Download Issue: 6th August 2004

Issue: 6th August 2004
CORPORATE NEWS
MERGERS & ACQUISITIONS
J&J tagged as potential bidder for Guidant
A Reuters news report has raised the possibility that Johnson & Johnson may be
considering a takeover bid for rival US cardiovascular device company, Guidant. The
report stems from heavy trading in Guidant's shares during the last week of July which
has seen the value of Guidant's shares increase sharply. The selection of J&J as
potential bidder, and Guidant as a would-be-willing partner, stems from the signing of a
joint market agreement in February 2004 between the two companies concerning the
development and marketing of J&J's Cypher stent with Guidant's Multi-Link Vision
stent delivery system. The agreement brought to an end a series of patent disputes
between the two companies and delivered a major obstacle to Boston Scientific's hopes
of dominating the drug-eluting stent market with its then newly FDA cleared Taxus
stent. The far reaching alliance surprised some observers with its potential scope, so it
was inevitable that talk amongst the media, investors and analysts would centre on the
possibility that they may go one better and consider a full blown merger.
Both companies are, not surprisingly, making no comment on such takeover speculation,
but J&J would be one of the few company's with deep enough pockets to buy Guidant,
and it could afford to as well, with annual sales from its Medical Device and Diagnostics
business run at US$15 billion and its Cordis unit makes an attractive partner. Guidant
is currently capitalised on the New York Stock Exchange at nearly US$17 billion, and a
successful bid would have to be in excess of that to attract the attention of its
management. So, it seems, the rumours will remain just that, but it is clear that
observers will increasingly look the progress of the alliance and scrutinise its activities
for signs of ever increasing collaboration, with speculation of a deal likely to continue to
affect the shares of both companies.
AGREEMENTS
Camtronics awarded cardiovascular image and information management contract
Camtronics, a subsidiary of Analogic, has announced that HCA Midwest, Kansas City,
MO, has selected Vericis for cardiovascular image and information management. A
division of HCA, HCA Midwest is an integrated delivery network that includes 12
hospitals and related healthcare entities serving Kansas City and surrounding areas.
When fully implemented, Vericis will leverage HCA Midwest's EMC enterprise data
repository for study archiving, giving clinicians immediate, centralised access to
diagnostic quality images from any location within the health system. Built on a single
information technology platform, VERICIS integrates data from different sites (office,
clinic, and hospital) and different sources (interventional and diagnostic X-ray
angiography, echo, nuclear, MRI, haemodynamics, reports and HIS) to create a digital
record on each cardiac patient.
Terumo/Spencer expand alliance to include cardiology and neurovascular markets
Terumo Cardiovascular Systems and Spencer Technologies have signed agreements
which give Terumo global rights to market and distribute Spencer's current offering of
diagnostic ultrasound products for cardiology and neurology applications, and future
products co-developed by the two companies. The two companies have been engaged in
similar agreements for monitoring products in the cardiac surgery market since 2002.
Spencer manufactures the PMD100 digital transcranial doppler system, an enhanced
ultrasound system for measurement of cerebral flow velocity and emboli detection. The
system is used for neurovascular diagnosis, and has also been used as part of a protocol
for the detection of patent foramen ovale (PFO), a hole in the wall that separates the
upper right and left chambers of the heart. PFO has been associated with stroke,
transient ischaemic attacks and migraine headaches. According to Terumo, the
PMD100's digital technology represents a number of improvements over traditional
analogue ultrasound technology, including increased accuracy and ease of use. Terumo
has also created a neurovascular monitoring business unit to provide current and future
diagnostic ultrasound devices to the cardiology and neurology markets.
Merit Medical Systems secures supply agreement with Novation
Merit Medical Systems has signed a supplier agreement with Novation, the supply
company of VHA and the University HealthSystem Consortium. The agreement takes
effect immediately and runs until 31st July 2007. The agreement covers Merit's line of
cardiology products, including diagnostic catheters, diagnostic guidewires, fluid
management kits and components, inflation devices and angioplasty accessories. The
new agreement also extends to healthcare organisations that purchase supplies through
HealthCare Purchasing Partners International, a company that markets Novation
purchasing agreements to non-members of VHA and UHC.
Meridian Medical to distribute DPA device
Meridian Medical, a subsidiary of Meridian Co, has signed a contract with CardioGrade,
based in Pleasanton, CA, to become its US distributor of the Digital Pulse Analyzer
(DPA). CardioGrade has projected a minimum sales goal of 50 DPA units per month
through the next quarter. Based on these projections, Meridian will receive revenues of
US$200,000 per month. Using information provided by a pulse waveform, the DPA
measures the elasticity of small and large arteries and provides information regarding
arterial ageing. CardioGrade claims the FDA approved device is inexpensive,
non-invasive and can provide results in one minute. The DPA can detect early signs of
arterial wall dysfunction, a precursor of peripheral vascular disease, heart attacks and
strokes. Such critical information can be used by the practitioner to determine if further
investigation is required or to monitor effectiveness of treatment choices such as
prescribed
lifestyle
changes
(diet,
exercise,
smoking
cessation
etc)
and/or
pharmaceuticals and nutraceuticals.
The DPA has a new software program that provides measurement of Heart Rate
Variability (HRV). Low HRV has been shown in numerous longitudinal studies to be
related to a higher mortality rate in both healthy and unhealthy subjects and thus can
be shown to be a strong predicator of all-cause mortality. Cardiovascular related issues
are not the only uses for the DPA. Psychologists are increasingly recognising the
importance of HRV. A number of studies have demonstrated that patients with anxiety,
phobias and post-traumatic stress disorder consistently show lower HRV, even when not
exposed to a trauma related prompt. Importantly, this relationship existed independent
of age, gender, trait anxiety, cardio-respiratory fitness, heart rate, blood pressure and
respiration rate.
COMPANY NEWS
BSI to assist Ventracor in EU approval process
Ventracor has appointed the British Standards Institution (BSI) as its notified body for
CE marking approval of its artificial heart device, the VentrAssist. European
certification is carried out by a notified body to conduct conformity assessments and
approvals for manufactured products sold in the EU. BSI will examine the VentrAssist
design and quality system for compliance with all relevant EU directives. The results of
the CE clinical trial will also be submitted and data will be assessed against the
requirements of the Active Implantable Medical Devices Directive. The CE mark trial,
which will begin soon, is the final step in the product validation process before sale in
Europe.
St Jude Medical targets growth through new business units
St Jude Medical is to create two new divisions by the end of 2004 as part of its ongoing
growth strategy. Reflecting the expansion and growth opportunities of its vascular
closure, cardiology and electrophysiology product lines, the company's Daig Division
will become two new divisions: cardiology and atrial fibrillation (AF), both of which will
be headquartered at the current Daig location in Minnetonka, MN. The St Jude Medical
Cardiology division will be led by Paul R Buckman, who has previously been Chairman
and CEO of ev3 and President of the worldwide interventional cardiology and radiology
businesses of Boston Scientific. The division will focus on maximising StJude Medical's
technology, products and services for cardiovascular catheterisations, and will build on
the market leadership position of the company's Angio-Seal vascular closure devices.
The company's angiography and catheter introducer product lines will be part of this
division. The St Jude Medical Atrial Fibrillation division will be led by Jane J Song who
has served as President of the company's Cardiac Surgery unit since 2002 and was
previously Senior Vice President, Operations for the company's Cardiac Rhythm
Management division. The new division will focus on medical technology and services to
help cure AF, as well as address the broad field of electrophysiology. The Epicor Medical
technology recently acquired by St Jude Medical will be part of the AF division as an
integral part of the organisation's focus on curative approaches to AF. The division will
also encompass all of Daig's technology, products and resources, not only for AF but also
for other types of electrophysiology catheterisation procedures. According to St Jude
Medical's Chairman, President and CEO, Daniel J Starks, the new structure of four
product divisions - cardiac rhythm management, atrial fibrillation, cardiology and
cardiac surgery - and two customer divisions - US and International - best aligns
leadership, infrastructure and resources with global growth priorities.
LITIGATION
Shareholders issue lawsuit against Thoratec
A class action has been commenced in the US District Court for the Northern District of
California on behalf of purchasers of Thoratec publicly-traded securities during the
period between 28th April and 29th June 2004. The plaintiff seeks to recover damages
on behalf of all purchasers of Thoratec’ securities during the class period. The complaint
charges Thoratec and certain of its officers and directors with violations of US law. The
company claims that its HeartMate XVE is an approved ventricular assist device
designed to provide permanent support for these patients. The complaint alleges that
during the class period, defendants made a number of false and misleading statements
regarding expected sales and the market for the HeartMate as a destination therapy
treatment for end-stage heart failure patients. As a result of these statements,
Thoratec's stock is alleged to have traded at artificially inflated levels and defendants
were able to complete a US$143.7 million note offering.
According to the complaint, the defendants knew but concealed from the investing
public a number of misleading material facts, including: the estimated number of
patients in the US that could be helped by their new destination therapy treatment
option, as well as the number of hospitals that qualified to carry out the treatment; the
potential negative impact of Medicare reimbursement policy for destination therapy;
grossly overstating demand for the company's destination therapy implants and
subsequent revenue projections; and revealing that sales of the HeartMate implants
would be depressed until the fourth quarter of 2004, with the result that the company's
earnings shortfall experienced in the first of 2004 would not be made up until the first
quarter of 2005.
On the 29th June 2004, Thoratec released its preliminary results for the quarter ended
30th June 2004. These results were much worse than previous forecasts. On this news
the price of Thoratec stock dropped precipitously to US$10.74 per share, a drop of more
than 25 per cent from the previous day's close, on extraordinarily heavy volume of over
11 million shares.
FINANCIAL NEWS
Guidant announces restructuring plan to combat declines in coronary stent operations
Led by strong sales growth for implantable defibrillators (ICDs), Guidant generated
record sales for the second quarter of fiscal 2004 of US$938.8 million, representing an
increase of 1.3 per cent over the same period in 2003, with currency favourably
impacting revenue by US$17 million. The company was able to reverse the net loss of
US$97.1 million reported in the second quarter of 2003 and generated net income of
US$126.5 million in the quarter.
In the six-month period, sales grew by 5 per cent to US$1.9 billion and the company
generated net income of US$265.9 million compared with a loss of US$3.7 million in the
same period last year. Special items in the first half of 2004 included US$50 million of
in-process R&D (IPRD) for Biosensors International's FUTURE II everolimus-eluting
stent trial, a US$15 million payment to Novartis for the completion of SPIRIT FIRST
clinical trial enrolment, US$6 million to purchase the remaining interest in
Bioabsorbable Vascular Solutions and US$22.8 million for the acquisition of AFx.
Special items in 2003 included US$35.2 million of IPRD for the Biosensors acquisition
and the achievement of a performance milestone related to the FUTURE I clinical trial,
US$16 million of IPRD for the Bioabsorbable Vascular Solutions acquisition and a US
422.8 million charge related to litigation with Johnson & Johnson’s Cordis subsidiary.
Guidant's quarterly revenue growth was led by sales of ICDs, biliary, peripheral and
cardiac surgery therapies, angioplasty products and pacemakers. Sales of ICDs rose by
21 per cent to US$456 million, with US sales up by 19 per cent to US$364 million, while
pacemaker revenue grew by 7 per cent to US$183 million, with US sales up by 3 per
cent to US$111 million. Sales of angioplasty products rose by 8 per cent to US 111
million and revenue from cardiac surgery, biliary, peripheral and carotid systems grew
by 32 per cent to US$68 million. However, sales of stents declined by 46 per cent to
US$120 million due to increased acceptance of drug-eluting stents and intensified
competitive pressures in Japan, where the company experienced a 60 per cent decline in
stent revenue.
In 2004 and 2005, declines in coronary stent sales are projected to be offset by growth
from the remainder of Guidant's product portfolio. Results for the rest of the year will
also be affected by a corporate-wide action to try and offset the decline in the company's
worldwide coronary stent business.
As a result of these actions, Guidant will record a pretax restructuring charge of US$50
to US$70 million in the third quarter of 2004, including severance for affected
employees and contract termination costs. Guidant expects third quarter sales of
US$890 to US$930 million and adjusted EPS of US$0.58 to US$0.62. Full-year 2004
revenue is expected to be US$3.65 to US$3.75 billion, with adjusted EPS of US$2.40 to
US$2.45. Including the impact of IPRD charges of US$0.24 per share in the first half of
the year and third quarter restructuring charges of US$0.10 to US$0.14 per share, EPS
is forecast to be US$0.44 to US$0.52 in the third quarter and US$2.02 to US$2.11 for
the full year. For 2005, the company is projecting sales of US$3.9 to US$4.1 billion and
adjusted EPS of US$2.52 to US$2.67. EPS will be US$2.28 to US$2.55, including the
impact of IPRD for the achievement of drug-eluting stent milestones of US$0.12 to
US$0.24 per share.
Vascular Solutions reduces losses
Vascular Solutions has announced that net sales for the second quarter ended 30th
June 2004, were US$5.24 million an increase of 93 per cent from the second quarter o
2003. Net loss for the quarter of 2004 was US$0.1 million improving from a net loss of
US$2.68 million in the second quarter of 2003. The primary contributor to the increase
in sales was the D-Stat Dry haemostatic bandage, which the company launched in
September 2003 for the topical control of bleeding in interventional procedures. Growth
in quarter sales also benefited from increasing sales of the Pronto extraction catheter,
which the company launched in January 2004, for the intra-arterial removal of
thrombus. In total, Vascular Solutions has launched four new products in the last 12
months, with over 60 per cent of its net sales in the second quarter coming from these
four new products. Net sales of the D-Stat Dry haemostatic bandage were US$2.1
million during the quarter.
The 3x3 version of the D-Stat Dry, which is designed for use in trauma indications,
received 510(k) clearance in March 2004 and has entered clinical evaluations in seven
trauma centres in the US as well as two US military operations in Iraq. The company is
completing these evaluations and entering into a distribution arrangement for revenues
starting in 2005. Net sales of the Pronto extraction catheter totalled US$0.69 million,
an increase of 77 per cent sequentially from the first quarter. Net sales of the Vari-Lase
endovenous laser product line increased to US$0.43 million in the quarter, whilst sales
of the Duett sealing device product line totalled US$1.6 million.
Boston Scientific's quarterly net income rises strongly despite costs for Taxus recall
Boston Scientific has reported strong operating results for the first half of fiscal 2004,
with revenue up by 71 per cent to US$1.5 billion in the second quarter and by 53 per
cent to US$2.5 billion for the year-to-date period, while net income grew by 175 per cent
to US$313 million and by 140 per cent to US$507 million, respectively. Secon -quarter
results included net special charges of US$64 million, including US$57 million for the
recall of certain units of the Taxus Express2 paclitaxel-eluting coronary stent and
Express2 coronary stent systems.
In the second quarter, the company’s US sales rose by 96 per cent to US$944 million and
international revenue was up by 39 per cent to US$516 million, or by 30 per cent
excluding exchange rates. Sales from the
Cardiovascular segment grew by 93 per cent to US$1.2 billion, driven by 105 per cent
growth for cardiovascular products (to US$1.1 billion), 11 per cent for electrophysiology
devices (to US$31 million) and 13 per cent for neurovascular products (to US$62
million).
The Endosurgery unit achieved a 12 per cent increase in revenue to US$268 million,
with oncology sales up 10 per cent to US$45 million, endoscopy revenue rising by 10 per
cent to US$159 million and urology sales up 19 per cent to US$64 million. The company
also generated US$7 million in sales of neuromodulation products gained through the
recent acquisition of Advanced Bionics.
For the six-month period, the company’s US sales rose by 58 per cent to US$1.5 billion
and international revenue was up by 46 per cent to US$1 billion, or by 33 per cent
excluding exchange rates. Sales from the Cardiovascular segment grew by 68 per cent to
US$2 billion, with 76 per cent growth for cardiovascular products (to US$1.8 billion), a
15 per cent increase for electrophysiology devices (to US$63 million) and 19 per cent
growth for neurovascular products (to US$126 million).
The Endosurgery unit generated a 14 per cent increase in revenue to US$531 million,
with oncology sales up 15 per cent to US$91 million, endoscopy revenue rising by 12 per
cent to US$317 million and urology sales up 17 per cent to US$123 million.
St Jude Medical reports solid sales growth
In the first six months of fiscal 2004, St Jude Medical has reported strong operating
results, with revenue up by 18 per cent to US$1.1 billion and net income up by 21 per
cent to US$194 million. Favourable currency translation comparisons increased first
half 2004 sales by about US$43 million, while earnings also benefited from reduced cost
of sales in the Japanese cardiac rhythm management (CRM) business due to the
acquisition of Getz Japan and manufacturing efficiency improvements within the CRM
unit as a whole. St Jude Medical’s achieved record sales and earnings results in both the
first and second quarters of the year. In the second quarter, revenue grew by 12.4 per
cent to US$556.6 million and net income rose by 23 per cent to US$98.8 million. Positive
exchange rates increased second-quarter sales by around US$19 million.
Within the company's CRM business, second-quarter sales of ICDs rose by 20 per cent
to US$127 million and the company claims to have gained market share for both
conventional and cardiac resynchronisation therapy (CRT) products in the international
market during the period. St Jude Medical’s pacemaker sales in the second quarter rose
by 7 per cent to US$227 million. Although US revenue fell by 6 per cent to US$116
million, this was offset by 19 per cent growth in the international market, to US$111
million, with US$8 million of this revenue due to positive currency effects. In the
electrophysiology (EP) catheter component of the CRM business, revenue grew by 16
per cent to US$37 million in the second quarter. Revenue from St Jude Medical’s
vascular closure business increased by 35 per cent to US$70 million in the second
quarter, with US$2 million due to favourable currency effects and the remaining growth
driven by strong customer demand for the Angio-Seal STS Plus product line. Sales of
other cardiology and vascular access products totalled US$24 million in the quarter.
Cardiac surgery sales in the second quarter rose by 3 per cent to US$72 million, with
US$3 million of the growth due to currency effects. Heart valve sales rose by 5 per cent
to US$67 million, while other cardiac surgery product sales totalled US$5 million. In
the third quarter of 2004, St Jude Medical expects ICD sales, including CRT devices, to
be in the range of US$150 to US$160 million; pacemaker sales to be US$225 to US$230
million; and EP catheter revenue to amount to US$35 to US$40 million. n addition,
revenue from vascular closure devices should total US$68 to US$73 million; sales of
other cardiology and vascular access products - US$22 to US$27 million; and cardiac
surgery revenue - US$66 to US$71 million. EPS for the third quarter is forecast to be
US$0.55 to US$0.57.
For the full year, St Jude Medical expects ICD sales, including CRT devices, to be
US$560 to 580 million, while global pacemaker sales should be US$895 to US910
million, representing 8 to 10 per cent growth from 2003. In addition, EP catheter
revenue is forecast to amount to US$150 to US$150 million; vascular closure devices
sales - US$275 to US 280 million; sales of other cardiology and vascular access products
- US$90 to US$100 million; and cardiac surgery sales - US$285 to US$295 million. R&D
spending is anticipated to amount to 12.5 to 13 per cent of revenue, increasing
sequentially during the year, and EPS is expected to be US$2.20 to US$2.23. Growth in
2004 and onwards is expected to be generated by St Jude Medical’s new CRT devices
and additional product launches. The company anticipates gaining FDA and CE mark
approval for the Frontier II device in the second half of 2004. This next-generation
low-voltage biventricular pacing system includes independent RV/LV timing outputs
and additional diagnostic features. St Jude Medical has also received an IDE from the
FDA for the QuickSite Bipolar left heart pacing lead which will complement the recently
launched unipolar version.
In addition, St Jude Medical’s recently-acquired Epicor Medical subsidiary has received
510(k) and CE mark clearance for its high-intensity focused ultrasound ablation system.
St Jude Medical will initiate limited sales of the system later in 2004 as part of an
expanded training and market development programme, but does not expect to
generate significant revenue from these programmes.
Kensey Nash raises prospects for fiscal 2004
Kensey Nash is raising its previously announced guidance for its fourth quarter and
fiscal year, with total revenues for the fourth fiscal quarter exceeding US$16 million,
surpassing the US$15.6 to US$15.9 million range previously announced. The increase
in guidance is due to stronger than expected net sales, combined with royalty income of
US$4.5 million in line with previously announced expectations. Angio-Seal royalty
income from St Jude Medical was US$4.3 million, with the balance from other royalty
generating relationships. Revenues for the fiscal year 2004 are expected to exceed
US$58 million, 30 per cent above fiscal 2003. Final results will be announced when the
financial audit is complete in mid-August 2004.
US sales boost Abiomed’s product revenues
Abiomed has reported that product revenues for the quarter ended 30th June 2004 were
US$7.4 million, a 47 per cent above the revenue reported in 2003. A 56 per cent increase
in US product revenue was partially offset by weakness in international sales. The
largest portion of the increase was attributable to sales of the AB5000 Ventricles and
AB5000 Consoles, as well as an increase in BVS Blood Pump sales. Price increases
across all product lines implemented during the final month of the quarter also
contributed to the year-to-year revenue growth and did not seem to have a restraining
influence on unit volumes. R&D expenses decreased by 20 per cent to US$3.3 million in
the quarter, related to lower AbioCor labour and material costs during the current
phase of clinical trial and to a shifting of some resources to commercial manufacturing
activities. R&D expense during the quarter consisted of continued clinical and
development efforts related to the AbioCor, the AbioCor II and continued efforts to
enhance and extend the BVS and new AB5000 product offerings. Net loss for the
quarter was US$2.4 million, a reduction of 25 per cent from the loss in the comparable
quarter of the prior year.
Thoratec sees drop in revenues despite rise in implants
Thoratec has reported that product sales for the second quarter of 2004 were US$40.6
million, a 12 per cent increase over sales of US$36.2 million in the second quarter of
2003. Thoratec reported net income of US$207,000 in the quarter, compared with net
income of US$1 million a year ago. For the first six months of fiscal 2004, Thoratec
reported product sales of US$83.4 million versus product sales of US$72.2 million in the
first six months of 2003. The company reported net income of US$1.5 million in the first
six months of 2004, compared with net income of US$2.4 million in the same period last
year.
The company reported that approximately 34 HeartMate XVE devices were implanted
for destination therapy during the quarter, bringing to approximately 76 the total
number of procedures performed in the first six months of 2004. The company reported
that it has now implanted 17 patients in its clinical trials for the HeartMate II, the
company's next-generation heart assist device, compared with six at the end of the first
quarter. Currently, 12 patients are being supported by the device, one for nearly nine
months. One patient has been transplanted successfully, and four have died due to
factors unrelated to the device. The company’s International Technidyne (IT) division
continued to deliver strong sales growth as revenues increased by 39 per cent over the
prior year. IT's performance reflected growing market share in the hospital point-of-care
and alternate site markets, the increase of IT's Hgb Pro testing system and the
continued integration of IRMA TruPoint products acquired in 2003. Without the effect of
sales from the IRMA TruPoint line, year-over-year sales growth at ITC would have been
26 per cent. Thoratec expects revenues for the full year to be in the range of US$175 to
US$180 million, which assumes approximately 200 destination therapy implants for the
full year.
Declines in CRM and Vascular Therapy units lead to lower earnings for Sorin
Sorin has announced a sharp decline in earnings for the first half of fiscal 2004
compared with pro forma results for 2003, with EBIT down by 82 per cent to EUR 1.4
million in the second quarter and by 71 per cent to EUR 3.7 million for the year-to-date
period. Although sales grew by 2.8 per cent to EUR 189.3 million in the quarter and by
3.4 per cent to EUR 367.5 million in the six-month period, and Sorin experienced a
significant improvement in the profitability of the Cardiac Surgery business, the
declines were due to weaker results from the Cardiac Rhythm Management (CRM) and
Vascular Therapy units, as well as higher costs for R&D and strengthening the sales
organisation. Sorin’s Cardiac Surgery business generated an 8.6 per cent improvement
in revenue on a comparable exchange rate and consolidation basis, to EUR 110 million
in the second quarter. This improvement reflected market share gains, particularly in
North America, driven by over 11 per cent sales growth for cardiac valves, including
over 30 per cent growth for tissue valves, as well as an 8 per cent increase in sales of
cardiopulmonary products such as oxygenators and extracorporeal circulation systems.
In the CRM unit, revenue grew by 3.9 per cent on a comparable basis to EUR 43.8
million in the quarter, although profitability was affected by the division modernising
and expanding its manufacturing facilities. The Vascular Therapy business reported a
13.8 per cent decline in comparable revenue to EUR 5.5 million in the quarter as a
result of lower market demand for conventional stents due to the launch of drug-eluting
stents. In addition, sales for the Renal Care unit rose by 4.3 per cent on a comparable
basis to EUR 29.2 million in the quarter. In the remainder of 2004, Sorin expects to
experience a continuing strong performance by the Cardiac Surgery division and a sales
and profitability turnaround by the CRM unit, which is expected to post double-digit
growth in the fourth quarter. The authorisation to begin marketing the Janus
drug-eluting stent, which is targeted for a European launch later in fiscal 2004, is
expected to open up a rapidly growing market to Sorin that offers high profit margins.
Zoll Medical boosted by North American hospital sales Zoll Medical has announced
third quarter revenues of US$54.54 million, an increase of 22 per cent. Net income for
the quarter was US$2.52 million, a decrease of 13 per cent. Quarterly sales to the North
American market grew to US$44.1 million, an increase of 31 per cent, whilst North
American hospital sales increased 60 per cent to US$21.9 million. Equipment sales to
the North American prehospital market increased 15 per cent to US$17.4 million, and
international sales decreased by 5 per cent to US$10.3 million. Total AED Plus product
sales increased by 61 per cent to US$7.8 million.
AngioDynamics triples net earnings to US$1.5 million
AngioDynamics, a majority-owned subsidiary of E-Z-EM, has reported net sales for the
fiscal 2004 fourth quarter of US$14.1 million, an increase of 26 per cent. The company
attributes the sales increase to solid market penetration for its new product launches,
as well as to continued growth of its core products. Operating profit for the quarter
increased 83 per cent to US$1.9 million, whilst net earnings for the quarter nearly
tripled to US$1.5 million, compared with net earnings in the prior-year period. For the
12 months, net sales were US$49.1 million, up 28 per cent from fiscal 2003. The
increase in net sales was due to new product introductions, the expansion of its US
salesforce and increased sales of existing product lines. Net earnings for 2004 were
US$3.1 million, up 165 per cent compared with 2003.
Quarterly losses increase for Cardiac Science
Cardiac Science’s revenue for the second quarter ended 30th June 2004 was US$17.5
million, a 20.5 per cent increase. Revenue from sales of AEDs and accessories for the
second quarter totalled US$13.8 million, compared with US$13.3 million. Sequentially,
revenue from sales of AEDs and accessories in the second quarter of 2004 increased 14.7
per cent from the first quarter of 2004. Revenue for the second quarter of 2004 from the
delivery of AED/CPR training and AED programme management services was US$2
million, up sequentially from US$1.7 million in the first quarter 2004. Operating
expenses for the quarter were US$13.2 million, compared with US$8.9 million in the
same period in 2003. The increase was due to new expenses related to AED programme
management services resulting from the business acquired from Complient in October
2003 of approximately US$1.1 million, increased US sales and marketing activities of
approximately US$1.4 million, the expansion of international sales and marketing
operations of approximately US$820,000, and increased legal, accounting, corporate
governance and insurance costs and provisions for bad debt of approximately
US$880,000. Operating expenses for the quarter increased sequentially over the first
quarter of 2004, due to increased direct marketing and selling expense of approximately
US$1 million, increased legal and corporate governance costs and provisions for bad
debt of approximately US$330,000, offset by a decrease of approximately US$220,000 in
R&D expense related to the timing of certain project development costs. The net loss for
the quarter was US$5.3 million, against US$2 million in 2003. Revenue for the six
months was US$33.1 million, a 16 per cent increase from 2003, whilst revenues form
the sales of AEDs was US$25.9 million, compared with US$25.7 million in 2003.
Operating expenses for the six months were US$25.6 million, compared with US$18.1
million in 2003. These increases were offset by a decrease of approximately US$700,000
in costs related to the relocation and expansion of facilities that took place in 2003. The
net loss for the six months was US$10.2 million, against US$4.6 million in 2003. In the
quarter, the company realised approximately US$1.4 million in sales of patient
monitors and CPR Prompt products which are expected to decline to approximately
US$100,000 in the third quarter as planned. Based on this reduction, the company
currently expects revenue in the third quarter to range between US$16.5 and US$18.5
million, which implies a sequential growth rate in core AED revenue of up to 16 per cent.
The company anticipates continued gross margin improvement in the fourth quarter as
additional reductions in AED material costs are realised.
ON THE MOVE
Lee named as Vice President Japan and Asia Pacific
Sorin has named Nam K Lee as Vice President, Japan and Asia Pacific, reporting to
Eric Beard, President International. Lee has been working in Japan and Asia Pacific for
more than 15 years in leading medical devices companies such as Baxter Healthcare,
Boston Scientific and Medtronic.
World Heart looks to new leadership
World Heart has announced the appointment of Jal Jassawalla as President and CEO
and the resignation of Roderick M Bryden from those positions and from the Board of
Directors of the company. C Ian Ross, Chairman of the Board, said the Board believed
that new leadership was required for the company to seize opportunities and build a
leadership position in the dynamic and rapidly evolving heart assist business.
Jassawalla founded Novacor Medical in 1979 and has led the development and
commercialisation of Novacor LVAS, having at various times directed R&D,
manufacturing, quality assurance, clinical technical support and having served as CFO
of Novacor Medical. In addition, Jassawalla that Dr Piet Jansen has been appointed to
Managing Director, Europe, effective immediately, and continues as Chief Medical
Officer. Previously Jansen, has worked for Edwards Lifesciences where he worked
directly with the Novacor LVAS, and with Jarvik Heart where he was Vice President
Clinical Affairs, prior to joining World Heart. Furthermore, John Marinchak is
appointed Vice President Marketing and Sales, effective immediately. In addition to his
current
field
sales
responsibilities
for
North
America,
Marinchak
assumes
responsibility for Marketing. Marinchak joined World Heart from Thoratec where he
was International Sales Manager. Finally, Robert W Corson has been appointed to the
position of Vice President Manufacturing. Corson joined World Heart in November 1997
as Vice President Manufacturing but left the company in August 2000 for health
reasons.
Abiomed unveils new development team
Abiomed has appointed Dr Karim Benali, as Vice President of Product Development,
and Vincent Wong as Director of Commercial Software Engineering. Benali brings to
Abiomed expertise in cardiology, bio-engineering and advanced technology development.
Previously, he held several global positions in R&D, product management and new
product development at GE HealthCare. Wong joins Abiomed with extensive experience
in commercial software engineering, overseeing development, upgrades, serviceability,
remote monitoring and diagnostics. Previously, he was the PET/CT Workstations
Product Manager for GE HealthCare.
MedicalCV reveals Heart division restructuring
MedicalCV has announced a restructuring of management to further reduce its
operating losses in its heart valve division and to reposition itself to better support its
new technologies. Richard Kramp, currently President of the New Technologies Division,
will become President and COO of the company. As a result of the strategic change,
Blair Mowery, President of the Heart Valve Division and Allan Seck, Vice President of
Business Development, will leave the company to pursue other business opportunities.
The company also announced that Robert Clapp is joining the company as Vice
President of Manufacturing and that it is conducting a search for a Vice President of US
Sales to strengthen both the valve business and the new products of the company.
However, the company did reveal that its first atrial fibrillation product, subject to
receipt of regulatory approval, could be available in September 2004.
PRODUCT NEWS
APPROVALS
Japanese approval paves the way for market release of Driver coronary stent system
Medtronic has received approval from the Japanese Ministry of Health, Labour and
Welfare to market its Driver coronary stent system in Japan. At the same time, the
Driver stent also gained reimbursement coverage, with immediate effect, and is now
available in Japan in diameters of 3.0, 3.5, and 4.0mm and in lengths of 9, 12, 15, 18, 24,
and 30mm. The Driver stent is a cobalt-based alloy stent and represents a
next-generation stent platform that incorporates thinner struts, a low profile and
advanced alloy to create aneffective stent therapy option for patients. Since its
introduction in the US and Europe in 2003, Medtronic clams the Driver has emerged as
a leading cobalt-alloy bare metal stent. The Driver stent system will be the first
cobalt-alloy stent available in Japan. The cobalt chromium alloy permits the Driver
stent to feature ultra-thin struts, providing physicians with the additional flexibility
needed for tracking through tortuous anatomy and for reaching difficult-to-access
lesions. The stent's small cells which each measure around 1mm squared) allow the
Driver stent to offer "excellent" support and coverage of the lesion, even when deployed
in tortuous anatomies. Furthermore, as the cobalt-based alloy is denser than stainless
steel, the Driver stent maintains optimal radiopacity, which means that it can be viewed
under fluoroscopy. As a result, the physician can precisely place the stent and more
clearly view the clinical result within the coronary anatomy.
CardioMag claims milestone FDA clearance for cardiac device
CardioMag Imaging has received clearance from the FDA to market and sell in the US a
cardiac device which can detect the magnetic field generated by a person's heart
According to the company, the CardioMag system has demonstrated that it is capable of
working in a typical open clinical setting, such as the non-invasive cardiology lab at
Cedars-Sinai Medical Center, where research is being carried out. The device is called a
magnetocardiograph (MCG) and six hospitals are already using the device to study, for
instance, the ability of MCG to detect coronary artery disease. According to Dr Peter
Smars of the Mayo Clinic who has been using the CardioMag MCG system since May
2003, if the ongoing clinical trial at various sites confirms expectations, MCG could
become standard diagnostic equipment in nearly every hospital in the US. An MCG
procedure takes less than ten minutes to perform, is risk-free, and does not require
injections or radiation. Generating a thousand images per heartbeat, CardioMag
believes its MCG system provides an insight into the human heart at work.
European clearance for EP-WorkMate with RPM technology
EPMedSystems has received regulatory approval from the European Notified Body for
its integration of Boston Scientific's Real-time Position Management (RPM) technology
with EPMedSystems' EP-WorkMate workstation. The new EP-WorkMate with RPM is
claimed to be the only EP recording system currently available on the market to
integrate advanced recording and stimulation, with anatomic modelling, advanced
mapping and 3D navigation features, allowing electrophysiologic studies to be more
efficient and user friendly.
Guidant obtains European approval for next-generation CRT defibrillator
Guidant has announced CE mark approval and first implant of its Contak Renewal 4
AVT cardiac resynchronisation therapy (CRT) defibrillator. The system is designed to
treat heart failure patients who are at risk for sudden cardiac death and also suffer
from atrial arrhythmias. Guidant plans to launch the system in Europe later this
quarter. The first implant took place at Kerckhoff-Klinik, Bad Nauheim, Germany, in
July 2004. The Contak Renewal 4 AVT system is designed to determine the origin of an
irregular heartbeat and provide the appropriate therapy. Once the origin and severity of
the arrhythmia is determined, the device provides either pacing therapy or delivers an
appropriate shock to return the heart to a normal rhythm. The system's diagnostic tools
also assist physicians in accurately diagnosing a patient's condition, documenting
symptoms, gaining clear insight into disease progression and monitoring the
effectiveness of the therapy.
FDA accepts reliability label revision and gives green light to begin Novacor LVAS
clinical trial
The FDA has approved World Heart’s PMA supplement application for a revision to the
labelling of the Novacor LVAS, to reflect the current device reliability data available to
patients and physicians. Notable in the revised labelling is the demonstrated
performance longevity of the Novacor LVAS, which encompasses implant duration from
zero to more than 36 months. The revised labelling, which is based upon statistical
analysis of 1,077 device implants, shows the chance for re-operation to either fix or
replace the Novacor LVAS is 1.6 per cent between zero and six months; 2.1 per cent
between six and 12 months; 11 per cent between 12 and 24 months; and, 16 per cent
between 24 and 36 months. The Physician's Manual will now also include the statement
that testing "revealed a single, non- catastrophic, device wear out mechanism, main
bearing wear, that is progressive and has detectable symptoms that can be proactively
and non-invasively monitored before wear out, permitting elective pump replacement".
World Heart has commenced site initiations in its RELIANT (Randomized Evaluation of
the Novacor LVAS In A Non-Transplant Population) trial, following the FDA’s
unconditional approval for the company's IDE supplement application relating to the
RELIANT trial. This equivalence trial randomises the Novacor LVAS against the
Thoratec Heartmate XVE. The data from this trial is expected to support a PMA
Supplement for use of Novacor LVAS by non-transplant eligible patients (destination
therapy). In May 2004, World Heart received conditional approval from the FDA with
five identified recommendations to the study protocol. The conditional approval
permitted full enrolment of recipients in the RELIANT trial, which will be conducted in
up to 40 clinical centres and will enrol up to 390 patients. The data from the trial will
support a request to revise the indications for the Novacor LVAS to include end-stage
heart failure patients that are ineligible for cardiac transplantation (destination
therapy).
The trial will evaluate the Novacor LVAS for destination therapy use by patients
suffering from irreversible left ventricular failure who are not candidates for
transplantation. Recipients will be randomised, on a 2:1 basis, to receive the Novacor
LVAS or Thoratec's HeartMate XVE LVAS. The objective of the trial is to demonstrate
that use of Novacor LVAS is superior to optimal medical therapy by demonstrating
equivalence to HeartMate XVE LVAS, which has been evaluated and approved for such
use. Abbott Laboratories’ Architect CK-MB test for heart attack diagnosis cleared in the
US Abbott Laboratories has announced a 510(k) clearance for a Creatine Kinase-MB
(CK-MB) test for use on Abbott's Architect i2000SR Immunoassay System and Architect
ci8200 Immunochemistry System. A cardiac marker used to assist in the diagnosis of a
heart attack, monitoring CK-MB values can help doctors determine if a patient has
damaged heart muscle. The test is the first part of Abbott’s acute cardiac panel for the
Architect platform; additional cardiac assays are in development or, in the case of
Troponin-I, under FDA review with a 510(k) submission filed in May 2004. Abbott
expects the Architect Stat CK-MB test to be available in August 2004. In June 2004,
Abbott introduced the test in major markets outside of the US. Providing stat results
within 18 minutes, the Architect i2000SR is an automated immunoassay system that
can perform up to 200 tests per hour. The stat functionality enables rapid turnaround
time of CK-MB results enabling doctors to quickly diagnose and treat patients with
chest pain. Combining immunoassay and clinical chemistry on one integrated platform,
the ci8200 system runs up to 200 immunoassay tests and up to 1,200 clinical chemistry
tests an hour. By consolidating both immunoassay and clinical chemistry testing
capabilities, the ci8200 helps improve laboratory productivity and efficiency. When
running tests to aid in the diagnosis of chest pain, tests can be run concurrently
supplying doctors with the rapid results they need to diagnose a potential cardiac event
and determine the best course of treatment.
PRODUCT LAUNCHES
Zoll gets FDA clearance for Lifecor in-hospital product
Zoll Medical has received FDA clearance to market Lifecor's Life-Padz WCD 3000S
System, a next-generation wearable cardioverter defibrillator. Zoll will now to market
and distribute this product to hospitals in the US for use with adult patients who are at
risk for sudden cardiac arrest. Data from the US-based National Registry of
Cardiopulmonary Resuscitation (NRCPR), which includes information on more than
14,000 adult in-hospital cardiac arrests, suggests that survival is improved when the
first defibrillating shock is delivered within three minutes. The Life-Padz WCD 3000S
offers an opportunity to improve the time to first shock, regardless of the patient's
location.
The system consists of a wearable monitor, a three-lead electrocardiogram (ECG)
system, and one set of therapy pads that are applied on the patient's chest and back.
The device continuously monitors a patient's heart through the ECG electrodes,
documenting critical events. If a life-threatening rhythm is detected, the device
automatically delivers an electrical shock to restore a normal heart rhythm.
In April 2004, Zoll announced an exclusive licence agreement, under which the company
secured all marketing and distribution rights to Lifecor's technology for in-hospital use.
Lifecor is obligated to produce product for Zoll, which will continue to use the Lifecor
and LifeVest brands in the hospital market.
US launch for Guidant’s Voyager RX catheter
Guidant has launched its latest line of coronary dilatation catheters, the Voyager
rapid-exchange (RX) coronary dilatation catheter, following FDA approval. The
company claims the catheter system combines several "exciting" new technologies to
enhance overall performance. In particular, the company highlighted its low-profile
tapered tip which assists the overall deliverability of the system. Coronary dilatation
catheters are used both in traditional angioplasty procedures and in stent implantation
procedures. By inflating a tiny balloon that has been delivered through a small incision
in the leg, the plaque is compressed, widening the artery and improving blood flow.
Toshiba offers multi-slice CT system for diagnostic cardiac applications
Toshiba America Medical Systems (TAMS) has unveiled the new Aquilion 64 CFX CT
system for examination of the coronary arteries. The system features TAMS' 64-row
Quantum detector for simultaneous 64-slice scanning with spatial resolution of 0.35mm,
volume imaging capabilities and proprietary software applications designed to
automate complex diagnostic cardiac studies. The Aquilion 64-slice CT scanner, which
has been scanning at the Fujita Health University in Japan since March 2004, is
currently performing clinical trials of its cardiac imaging capabilities and will be
available for delivery in 2005. The system is built on the same platform as the Aquilion
32, using the Quantum 64 detector that has scanned more than 3,000 patients
worldwide. Aquilion 32 users can upgrade to the new system with a simple field
modification.
At the heart of the Aquilion 64 CFX is its Quantum 64 multi-row detector design, a
sophisticated CT detector that provides high-speed, high-resolution imaging with low
noise. The Quantum 64 detector enables the Aquilion CT scanner to acquire 64
simultaneous image slices through an advanced 64-row data acquisition system (DAS)
at a 400-millisecond gantry revolution. The Aquilion 64 CFX, in combination with the
Quantum 64, also provides the low-contrast resolution at 2mm and isotropic voxel size
of 0.35mm to ensure multi-plannar image quality and accuracy. The result is precise
isotropic imaging of any region of the body with reduced breath-hold times. In order to
optimise the Aquilion 64 CFX and its Quantum detector for cardiac CT imaging, TAMS
offers SUREWorkflow applications suite to ensure image quality, repeatability and
productivity by automating complex CT studies. The SUREWorkflow application suite
for the Aquilion 64 CFX includes: SURECardio, an automated cardiac scan protocol
clinically validated to ensure the best temporal resolution regardless of a patient's heart
rate or condition; and SUREPlaque, a soft plaque identification and measurement
protocol for cardiac and peripheral vessel analysis using a colour-coding system based
on tissue density.
PRODUCT UPDATES
Panel recommend expansion of CRT indications based on COMPANION results
The Circulatory System Devices Panel of the FDA has unanimously recommended
approval, with conditions, for expanded user labelling, including indications, for
Guidant's cardiac resynchronisation therapy (CRT) defibrillators. The FDA will now
consider the recommendation prior to making its final decision. Guidant's submission is
based on results of the Comparison of Medical Therapy, Pacing and Defibrillation in
Heart Failure (COMPANION) trial. The latter included 1,520 heart failure patients
from 128 clinical trial sites across the US. All patients had advanced heart failure, a
wide QRS and depressed pumping function of the left ventricle. All patients received
optimal heart failure drug therapy. The COMPANION trial used Guidant's Contak TR
CRT pacemaker in one patient group and the Contak CD CRT defibrillator in another
patient group. The third patient group received optimal drug therapy only. The Advisory
Panel voted unaminously in favour of expanding indications and labelling approval to
cover the entire COMPANION population.
Trial results achieved the primary endpoint of a risk reduction for events consisting of
either time to death or first hospitalisation, for any cause, following implant of CRT
pacemakers or defibrillators. Additionally, treatment with resynchronisation therapy
defibrillators demonstrated a 36 per cent reduction in all-cause mortality.
Thoratec welcomes VAD reimbursement decision Keith Grossman, President of
Thoratec, has reacted favourably to news that, for the fiscal year beginning 1st October
2004, all VADs implanted for destination therapy in the US will be reimbursed under
DRG (diagnosis-related group) 103, which currently covers heart transplantation
procedures. The notice was filed in the Federal Register by the Centers for Medicare &
Medicaid Services (CMS). This notice is the finalisation of the proposed rule from CMS
in May 2004 that recommended this specific change. With this decision, reimbursement
for destination therapy will increase by approximately 30 per cent, with the average
Medicare payment to CMS-recognised destination therapy facilities increasing to
approximately US$125,000 to US$130,000. Thoratec's HeartMate XVE LVAS is the only
FDA-approved device for destination therapy, or the permanent support of end-stage
heart failure patients who are not eligible for heart transplantation. The company
received this approval in November 2002. Thoratec's believes this reimbursement will
encourage more hospitals to begin developing the infrastructure necessary to support
the procedure and be an important catalyst for the long-term development of the
market.
R&D
Wake Forest University examines method of screening for heart disease
According to the results from a multi-centre study led by Wake Forest University
Baptist Medical Center cardiologist, Dr David M Herrington, measuring the stiffness of
arteries to screen for early atherosclerosis may be another way to identify people at risk
for heart disease or stroke. The study was published in the July 2004 issue of
Circulation, a medical journal of the American Heart Association. The blood vessels of
individuals who are in the early stages of atherosclerosis begin to stiffen due to the
build up of plaque on the interior walls of the vessels. Using a non-invasive test to
detect this disease would allow treatment to begin much earlier in an effort to reduce
the odds of further cardiovascular disease. The study, which involved 267 participants,
showed that measurements taken with a blood-pressure-like test, and confirmed with
MRI, were "strongly predictive of extent of aortic atherosclerosis." The device measured
blood volume in the leg as a way to gauge artery stiffness. In addition to Wake Forest
Baptist, the study was conducted at the Atlanta VA Medical Center, Columbia
University Medical Center, and Jackson Memorial Hospital at the University of Miami
Medical Center, FL.Herrington said the test is still under development and not yet
ready for clinical use and claimed that a further study of the test was warranted. The
project was supported in part by a grant from Credit Swisse First Boston.
Recom begins ambulatory ECG system user preference studies
Recom Managed Systems will be undertaking a "user preference study" under the
supervision of a third party Institutional Review Board. The purpose of the study will be
to comparatively test Recom's first generation device against existing ambulatory ECG
systems using volunteer subjects. The study, to be conducted at a newly-completed
Recom product evaluation laboratory, will provide the company with the comparative
data needed to finalise user preference input and configurations as commercialisation
efforts are being prepared. The Recom ECG monitor system utilises the company's
patented signal technology which produces a high fidelity ECG signal in the presence of
ambient noise. This capability allows ambulatory recording to become another source
for diagnostic 12-lead ECG records on a par with other modalities such as resting ECG
and exercise stress testing. Recom believes this effort will demonstrate its superior ECG
signal quality under a range of ambulatory/stress conditions and assist in the final
production configuration of the company's first device. Since receiving FDA marketing
clearance for the device in 2004, the company has been preparing for its forthcoming
product launch.
Boston Scientific to begin ATLAS paclitaxel-eluting trial after receiving IDE
Boston Scientific has received an IDE from the FDA to begin its ATLAS clinical trial,
the first clinical trial using to use the company's new Liberte coronary stent as a
platform for its paclitaxel-eluting coronary stent system. Taxus Liberte will be the
next-generation to Boston Scientific's current paclitaxel-eluting stent system, Taxus
Express2. The Liberte stent, which has been designed to further enhance deliverability
and conformability, particularly in challenging lesions, is currently available in
international markets in a bare metal version. The ATLAS trial is a pivotal study to
collect data to support regulatory filings for product commercialisation. It is designed to
assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting
Taxus Liberte stent system for the treatment of coronary artery disease. The trial is
scheduled to enrol 822 patients at 60 sites in the US, Canada, Australia, New Zealand,
Singapore, Hong Kong and Taiwan.
Edwards reports milestone development for self-expanding stent
Edwards Lifesciences has announced the successful treatment of the first patient in its
RESILIENT (Randomised Study Comparing the Edwards Self-ExpandIng LifeStent vs.
Angioplasty-alone In LEsions INvolving The superficial femoral artery or proximal
popliteal artery) clinical investigation using the Edwards LifeStent NT self-expanding
stent system to treat patients with peripheral vascular disease. The LifeStent NT
self-expanding stent is a percutaneously-delivered flexible mesh tube that expands
when deployed to prop open a diseased vessel. The first patient, who was suffering from
peripheral vascular disease in his superficial femoral artery (SFA), was treated by one
of the study's co-principal investigators, Dr John Laird, Director of Peripheral Vascular
Interventions at the Cardiovascular Research Institute at the Washington Hospital
Center, Washington, DC. The SFA is a blood vessel in the back of the leg that extends
beyond the knee as the popliteal artery. This is a common area of blockages in patients
who suffer from atherosclerosis of the lower extremities, causing moderate to severe
pain due to poor blood flow in the leg muscles.
Edwards' RESILIENT study is a randomised, controlled clinical trial that differs from
other SFA investigations because it is intended to demonstrate superiority, not
equivalence, of the LifeStent NT self-expanding stent system over PTA in treating
blockages in the SFA and popliteal artery. Approximately 220 US patients are expected
to be enrolled in the RESILIENT trial, which will take place at up to 25 medical
institutions throughout the country.
At the same time, Edwards has begun a limited launch of the first sizes of its Edwards
LifeStent NT stent system for use in treating biliary disease. The stent's
proprietary, self-expanding triple helix design provides physicians with a highly flexible
intraluminal scaffold with sufficient radial strength to address clinical needs in a
challenging area of the anatomy. Edwards is currently seeking CE mark approval to
market the system to treat peripheral vascular disease, and plans to continue to
introduce additional stent sizes throughout the third quarter of 2004.
IDE approval for St Jude Medical bipolar CRT lead
St Jude Medical has received IDE approval to begin enrolment in the fourth phase of
the US-based RHYTHM (Resynchronisation HemodYnamic Treatment for Heart
Failure Management) ICD study, which is evaluating the QuickSite 1056T bipolar
left-heart pacing lead, the next advance in the QuickSite range of left-heart leads to be
introduced for cardiac resynchronisation therapy (CRT). The first implants of the lead
were most recently performed by Dr Stephen J Ackerman at St Elizabeth Regional
Medical Center in Lincoln, NE, and Dr James H Baker II at St Thomas Hospital in
Nashville, TN. In Ackerman's case. the lead was implanted along with the Epic HF
CRT-D.
The QuickSite 1056T bipolar lead, which at 5.5Fr is as small in diameter as the
previously approved QuickSite 1056K unipolar lead, is specifically designed for
placement in the coronary sinus to enable left-ventricular pacing in CRT applications.
The lead incorporates important advances, including a polyurethane body that
transitions to a distal silicone tip section for optimal pushability, torque transfer and tip
flexibility. It also has a steerable, S-shaped distal tip designed to improve
manoeuvrability and anchoring of the lead at distal as well as more proximal locations
within the coronary sinus, whilst a choice of either a ball-tipped guiding stylet or a
guidewire is available during the same implant for maximum flexibility in lead
placement. A radiopaque suture sleeve enhances visibility on fluoroscopy without
blocking visibility of the underlying coils, and grooved, circumferential tip electrodes
enhance stability and thresholds. The new biopolar lead is designed for use with the St
Jude Medical Epic HF CRT-D, said to be the world's smallest high-voltage CRT device,
and the Atlas+ HF CRT-D, a high energy output CRT device, to treat heart failure.
Devax commences Axxess stent system trial
Devax has initiated the Axxess Plus clinical study for the company's Axxess drug-coated
stent system. The Axxess stent system is said to be the first bifurcated stent design to
elute an anti-restenonic drug. The Axxess Plus clinical study is a multi-centre trial to
evaluate both the acute and long-term clinical utility of the Axxess stent system for the
treatment of bifurcated lesions in native coronary arteries. Most recently, two patients
were treated with the Axxess system in two clinical centres in Germany. The stent
system was successfully implanted in both patients with no acute complications. Devax
expects to add up to 15
international centres in the Axxess Plus study over the next few months and complete
patient enrolment by the end of 2004. All patients will receive six-month follow-up
angiography to evaluate long-term outcomes. Devax' Axxess technology is a patented,
multi-component stent delivery system comprising self-expanding nitinol stents
specifically engineered for the treatment of coronary and vascular bifurcation lesions.
The system includes a conical stent that conforms to the bifurcation anatomy and
provides full access to both side branches for additional interventional procedures.
Devax has licensed the drug, Biolimus A9, and a polymer coating from Occam, an
affiliate of Biosensors International. The Axxess stent system with Biolimus A9 has
already completed a series of preclinical tests.
MacroPore pursues development of adipose-derived regenerative cells to treat heart
attacks
MacroPore Biosurgery has been awarded US$750,000 as part of the second phase of a
National Institutes of Health SBIR grant. The latter was awarded for the study of the
potential role of adipose-derived regenerative cells in treating heart attack and to
support future application of these cells in human clinical trials.
The second phase follows the successful completion of the first stage, which included an
award of US$100,000, and demonstrated in an animal model that adipose-derived
regenerative cells may be useful for treating heart attack. The research is being
conducted in collaboration with Dr W Robb MacLellan at the David Geffen School of
Medicine at the University of California, Los Angeles. In the second phase, MacroPore
will study the safety and efficacy of these cells in a large animal model of acute
myocardial infarction.
Abbott submits Troponin-I ADV test to the FDA
Abbott Laboratories has submitted a 510(k) application to the FDA seeking clearance of
the Troponin-I ADV test for use on the company's AxSYM automated immunoassay
instrument system. Troponin-I is a protein that is released from dead or severely
injured heart muscle cells following a cardiac event. Following appropriate regulatory
approvals, the new test would replace the existing AxSYM Troponin-I assay in the US
and other major markets throughout the world.
Part of an acute cardiac diagnostic menu, doctors consider troponin assays to be one of
the most important tests to use when diagnosing heart attacks. The AxSYM
immunoassay system can process up to 80 to 120 tests per hour allowing
medium-volume clinical laboratories to process a variety of immunodiagnostic tests
simultaneously. Test menus include assays for abused drugs, cancer, cardiac,
endocrinology, fertility, hepatitis, infectious disease, metabolic/renal, therapeutic drug
monitoring and toxicology.
Cook to commence US DESTINY trial
Cook is set to begin the first US clinical trial of a drug-coated stent for a peripheral
(non-coronary) artery. The study will examine whether drug-coated stents, which have
shown clinical success in treating coronary artery disease, can have similar benefits in
treating peripheral vascular disease.
Cook's DESTINY trial (Drug-Eluting StenT IN the SFA/Fempop ArterY) is the first
clinical investigation approved by the FDA to study the effectiveness of a drug-eluting
stent for a peripheral artery. The trial will investigate the use of the Zilver PTX
paclitaxel-eluting stent in the above-the-knee femoropopliteal artery. It will be
conducted initially at ten US medical facilities and will enrol 60 patients, with an
expanded trial likely pending further FDA review. The company expects to enrol its first
patient in the DESTINY trial in September 2004.
The DESTINY trial will examine whether the Zilver PTX self-expanding vascular stent
coated with the anti-tumour agent, paclitaxel, can provide clinical benefit to patients
receiving stents in the femoropopliteal artery. The Zilver PTX peripheral stent is an
investigational device not approved for sale in the US.
MRI safe to use with modern heart devices - study shows Scientists at Johns Hopkins
have shown that modern, implanted heart assist devices can be safe for use in MRI
machines, in animal and laboratory studies. Their findings, published in the 3rd August
2004 issue of Circulation, could eventually make MRI scans more available to people
who might benefit from early detection of cancer and other diseases, when treatments
are most likely to succeed, and for guiding devices during minimally-invasive surgery.
Precise
MRI
guidance
of
surgical
instruments
would
improve
laparoscopic,
minimally-invasive and ablative surgical techniques, but is not currently recommended
for people with implanted heart devices. This study was funded by Medtronic, St Jude
Medical, the Bogle Foundation and the National Institutes of Health.
Dr Henry Halperin, Professor of Medicine, Radiology and Biomedical Engineering at
The Johns Hopkins University School of Medicine, said that many people, such as the
elderly and patients with arrhythmogenic right ventricular dysplasia, who might
benefit from an MRI scan are currently denied them because they have an implanted,
electrical heart device. The fear is that the electromagnetic fields of the MRI may heat
up metal components, or pull on and dislodge the device, causing tissue damage, device
malfunction or possibly death. Over a six-month period, the Hopkins team tested a
broad range of devices from among the hundreds of brands and models currently in use,
including nine pacemakers, 18 defibrillators and 40 different lead systems. Each type of
device was tested under a variety of electro-magnetic field strengths using one
MRI scanner, a 1.5T by manufactured by GE.
Using models filled with salt water or gel to simulate conditions inside the human body,
the researchers evaluated every model for its safety and functionality. They wanted to
determine if MRI heated the electrical, metal lead components of the device; to test the
electromagnetic field to see if it dislodged or caused a pulling effect on the devices,
which are housed in a titanium metal casing; and, fundamentally, to check if MRI
caused malfunctions in the devices or produced distortions in the resulting diagnostic
image. Results showed most modern devices are safe and perform well in both standard
MRI scans and when scans are performed using electromagnetic fields at maximum
strength. Lead components never heated more than 5ºC when exposed to the
electromagnetic fields and only at maximum strength. It was feared that the
radiofrequency waves of the MRI scanner would react with the lead components and, as
with any metal antennae, produce intense heat. However, the researchers found that
the lead components were too short to provide adequate coupling of the radiofrequency
energy to produce sufficient heat to cause tissue damage. Protective capacitors within
the devices also filtered out the radiofrequency waves.
The pull of the electromagnetic field on heart devices was negligible, never amounting
to more than the equivalent of a 100g. Modern devices are smaller, weighing on average
40g, Furthermore, the researchers highlight that titanium, the most widely used metal
for pacemaker casings, is almost completely non-magnetic. Tough scar tissue also forms
around heart devices after implantation, preventing their movement without the aid of
surgical cutting instruments. Device function for the defibrillators was measured for
four weeks after implantation using the 1.5T scanner. Selected, modern devices,
manufactured after 2000, performed well. Malfunction was observed in the batteries of
some defibrillators, but only in those manufactured before 2000, and some noise
distortions were misinterpreted as ventricular defibrillation. The reasons remain
unclear for the battery problems with older defibrillators. Overall, MRI testing using a
variety of existing clinical procedures yielded good images with negligible distortions or
artifacts (visible abnormalities created by the picture-taking process).
Kensey Nash submits FDA application for TriActiv system
Kensey Nash has submitted an application for 510(k) clearance for its TriActiv system
to the FDA. The protection system is designed to prevent material or debris, dislodged
during stent procedures, from embolising downstream and causing adverse coronary
events such as a heart attack. This is accomplished with three integrated system
features: an embolic protection balloon and a combined active flush and extraction
system to remove the problematic debris from the target vessel.
According to the company, the current market for these types of embolic protection
systems is estimated to approximate US$100 million worldwide and is expected to grow
substantially over the next several years as next-generation products are developed and
as indications are expanded. The application for 510(k) clearance contains data from
Kensey Nash's PRIDE (PRotection during saphenous vein graft Intervention to prevent
Distal Embolisation) trial which compared the TriActiv device against other approved
embolic protection systems for the treatment of saphenous vein graft disease. The
PRIDE study enrolled 894 patients at 68 sites in the US and ten sites in Europe. Data
from the PRIDE trial will be presented at the "Late Breaking Trials Session" of the
Transcatheter Therapeutics Conference to be held in Washington, DC, in September
2004. The TriActiv system is currently approved for sale for the saphenous vein graft
indication in the EU. Kensey Nash is selling direct to customers in Germany and
through distributors in other countries in Europe. The company is working to extend
the TriActiv platform to ultimately address all vessels where embolic protection is
important for patient safety.
Researchers develop strain test that monitors aortic aneurysm stress
Researchers at the University of Warwick have found a way of modeling the stress that
surgical procedures would put on an aortic aneurysm, using a test devised in the 1930s
to gauge the stress on the superchargers in wartime spitfire fighter planes.
Photoelasticity examines the patterns of coloured light reflected from the surface of an
object to gain a detailed understanding of the stresses on that object. In its most modern
incarnation photoelectric stress analysis uses high tech light sources and computer
analysis to get an even more precise understanding of the stresses involved. Initially,
surgeons from University of California had tried placing mechanical strain gauges on
an aortic aneurysm as they manipulated it but found that the gauges themselves placed
an unwelcome additional physical strain on the aortic aneurysm. They turned to
researchers at the University of Warwick led by Geoff Calvert who had an idea that
would combine photoelastic stress analysis with the technology of rapid prototyping to
solve the problem. The University of Warwick and UCL researchers took a 3D scan of
the patient's actual aortic aneurysm and used rapid prototyping technology to produce
an exact latex duplicate of the aneurysm. They then covered the duplicate with a
reflective coating and used photoelastic stress analysis to examine the stress on the
model aneurysm as the surgeon manipulated it. Dr Arindam Chaudhuri, a heart
surgeon carrying out research at UCL, said that the technique allows surgeons to
explore a greater range of possible interventions and manipulations of an aneurysm and
get a clear picture of the stresses created without the obvious risks that testing less
conservative interventions would bring if they were tried out on the actual patient.
University of Warwick researchers are seeking further funding to research materials
that could be used in the rapid prototyped aortic aneurysm that would provide an even
closer mimic of the mechanical properties of the original aortic aneurysm. They are also
looking for support to develop another technique that would stretch the ability of
current photoelectric stress analysis equipment to draw on the more limited reflective
properties of the original aortic aneurysm which would provide surgeons with a real
time monitor of the stress on the aneurysm as they operate.