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ChangeWave Research: Golden Age of Cardiac Care
ChangeWave Research Report:
Golden Age of Cardiac Care
Implantable Defibrillators Thrive–Coated Stents Steady But Not Yet Stellar
Abstract
The findings of our March 2003 report on stents and defibrillators showed sales of
Implantable Cardiac Defibrillators (ICDs) would exceed analyst projections, but new
drug-eluting stents would launch somewhat slower than expected. Subsequent events
have shown both Alliance findings to be on target.
During the week of August 19-25, 2003 we went back to our Alliance Healthcare
members to learn more about new trends in cardiac devices and treatments. A total of
101 members participated in the survey. Some key findings:
The ICD Market Continues to Thrive. The ICD market is expanding rapidly and the
private marketplace is following Medicare's lead.



By nearly a 6-to-1 margin (59% vs. 12%), respondents believe ICD use will continue
to expand due to increasing usage by new patients.
45% believe ICD sales are solely achieved by educating customers and supporting
physicians who use the devices. Medtronic (56%) is considered the leading brand.
53% of respondents believe hybrid devices (pacemaker and defibrillator) will steadily
replace pacemaker-only units if covered under Medicare.
New Coated Stents are Doing Steady, but Not Yet Stellar. The new drug-eluting
stents are continuing to capture market share at a steady, but not yet stellar pace.


72% expect a "Rapid" or "Dramatic" adoption rate of 25% or more for drug-eluting
stents over the next 12 months. But while 41% see rapid physician acceptance, 47%
see physicians adopting these devices at a rate typical for any new cardiac device.
By a 56% to 12% margin, respondents said patients are eagerly seeking information
about the new drug-eluting stents.
Other Key Findings:


Cardiac scanning technology is emerging as a major growth area.
BioSite's Triage BNP cardiac test has a modest 28% brand recognition, which may
pose problems as it appears headed for a serious challenge from big competitors.
Bottom Line: The key trends first underscored in our February 2003 survey – stronger
than expected ICD sales and a steady but not yet stellar rise in market share for coated
stents – will continue to shape these markets at least through mid-2004.
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ChangeWave Research: Golden Age of Cardiac Care
Table of Contents
Summary of Key Findings ............................................................................................ 3
The Findings .................................................................................................................. 4
Drug-Eluting Stents .................................................................................................... 4
Implantable Cardiac Defibrillators (ICDs) ................................................................... 8
Other Cardiac Devices and Treatments ................................................................... 10
Summary and Analysis.................................................................................................. 15
ChangeWave Research Methodology ....................................................................... 17
About ChangeWave Research ................................................................................... 18
Copyright ©2003 ChangeWave Research
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ChangeWave Research: Golden Age of Cardiac Care
I. Summary of Key Findings
Drug-Eluting Stents
Gain At A Steady But
Not Yet Stellar Pace



72% see "Rapid" or
"Dramatic" adoption
rate (25%+) for new
stents over next 12
months
But while 41% see
rapid physician
acceptance, 47% see
physicians adopting
these devices at a rate
typical for any new
cardiac device
By 56% to 12%,
respondents say
patients are eagerly
seeking info about the
new stents
Defibrillator Outlook
is Strong
Prognosis: Healthy
Cardiac Markets




By 59% to 12%,
respondents see ICD
usage continuing to
expand
45% said ICD sales
are solely achieved
by educating
customers and
supporting physicians
who use them. Few
see major differences
between brands.
Medtronic (56%) is
easily the most
recognized brand in
ICD market, followed
by Guidant (12%) and
St. Jude Medical (6%)
The key trends first
underscored in our
February 2003 survey
– stronger than
expected ICD sales
and a steady but not
yet stellar rise in
market share for
coated stents – will
continue to shape
these markets at least
through mid-2004.
Other Key Trends


Cardiac scanning is
emerging as a major
growth area
BioSite's Triage BNP
cardiac test appears
headed for a serious
challenge from big
pharma competitors
Overview
The findings of our February 2003 report on stents and defibrillators showed sales of
Implantable Cardiac Defibrillators (ICDs) would exceed analyst projections, but new
drug-eluting stents would launch somewhat slower than expected. Subsequent events
have shown both findings to be on target.
During the week of August 19-25, 2003 we went back to our Alliance Healthcare
members to learn more about new trends in cardiac devices and treatments. A total of
101 members participated in the survey, which focused on three areas:



Drug-Eluting Stents
Implantable Cardiac Defibrillators
Other Cardiac Devices and Treatments
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ChangeWave Research: Golden Age of Cardiac Care
II. The Findings
A. Drug-Eluting Stents
(1) Question Asked: How would you characterize the probable rate of change
from traditional to coated or drug eluting stents over the next year?
Current Previous
Survey
Survey
Aug 2003 Feb 2003
Dramatic - 50% or more of all new procedures within one year
Rapid - 25-50% of all new procedures within one year
Typical - 10-25% of all new procedures within one year
Measured - less than 10% of all new procedures within one year
Don't Know
No Answer
23%
49%
18%
2%
8%
1%
28%
47%
21%
2%
0%
0%
Coated Stents Will Gain Momentum in Coming Year. Nearly three-quarters (72%) of
respondents see either a "Rapid" or "Dramatic" adoption rate (i.e., 25% or better) for
drug-eluting stents from the older, traditional stents during the next 12 months. These
results signal a pick-up in momentum for coated stents. Meanwhile, only 18% anticipate
a typical changeover rate (i.e., 10% - 25% of all new procedures within one year).
(2) Question Asked: Based upon statistical analyses of clinical trials by
manufacturers, the new coated stents offer a materially better set of outcomes for
patients than traditional metal stents - but they also cost three times as much.
How are physicians and other health care professionals responding to this
clinical trial data?
Physicians and other health care professionals are accepting coated stents at a
very rapid rate, and they will dominate the market within six months
Physicians and other health care professionals are accepting the new stents at a
rate similar to their acceptance of other new cardiac devices and treatments
Physicians and health care professionals are somewhat skeptical of claims by
manufacturers, and acceptance of coated stents will be slower than that of other
new cardiac devices and treatments
Don't Know
41%
47%
2%
11%
But Doctors' Level of Acceptance May Temper Adoption. Two-in-five respondents
(41%) believe that rapid physician acceptance of the new coated stents will result in
market dominance within six months. However, 47% see the new coated stents being
adopted at a rate typical for any new cardiac device or treatment. The relative closeness
indicates that swift acceptance of coated stents may be tempered over the near term by
moderating forces in the healthcare community.
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ChangeWave Research: Golden Age of Cardiac Care
(2A) Question Asked: Please elaborate.
The question of costs versus benefits is at the center of most of the responses on this
issue. Respondents who see a rapid rate of acceptance for coated stents generally
believe their efficacy overrides cost considerations.
Alternatively, respondents who see the acceptance of coated stents as being on par
with other new cardiac devices, believe that the adoption of any new medical
technology – no matter how useful – takes time to overcome obstacles – such as
reimbursement issues and limited field experience.
Sample of Alliance Member Responses
a. Members Who Said: “Physicians and other health care professionals are
accepting coated stents at a very rapid rate, and they will dominate the market
within six months” (41%)

RID4768 writes, “As a physician, you always offer the best to the patient. In this
case, if the stent has materially better outcomes, it could be more cost effective in
the long run.”

DDY0175 writes, “The coated stents have significantly better outcomes. There is not
likely going to be a problem getting cardiologists to recommend them to patients.
The holdup will be the insurance companies' willingness to pay for them. “

KER5863 writes, “At our institution the use of coated stents has increased
dramatically. The results have had a significant reduction in the number of CABG
procedures performed at our institution resulting in a 20% reduction of operative
coronary artery bypass grafting in the last year.”

QUA1514 writes, “It is a matter of risk management. Physicians are risk averse (the
great majority). The coated stent gives them a parallel or redundant system (the
mechanics of the wire and the drug).”

JEF7065 writes, “Several cardiologists I work with from different groups are very
excited about using the coated stents and only wish they had them available
sooner.”

CLI1209 writes, “The coated stents have the best - lowest - rate of restenosis by far.
Patients and doctors will want the safest therapy and best possible outcome. In
addition, no surgeon will risk legal complications if restenosis follows use of
traditional stents.”

SOM4483 writes, “Demand for J&J's stents is high. Only problem is lack of supply of
these stents. Many patients are already aware of the new drug eluting stents and are
demanding them. BSX stent will not arrive in the US market until early Q1 2004 in
my opinion. Cost of stents is justified by their efficacy and the cost savings of not
having to go back to the cath lab for correction of a restenosis. Medicare is already
willing to pay $2,800/stent. I can't remember the last time I saw this type of
Copyright ©2003 ChangeWave Research
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ChangeWave Research: Golden Age of Cardiac Care
reimbursement by Medicare for a therapy that hadn't even hit the market yet.”

WPW6938 writes, Anytime a materially better outcome can be assured, the product
will be recommended and requested more often. What stent do want in your
coronary artery, a cheap one or one with better known outcomes that costs more?”
b. Members Who Said: “Physicians and other health care professionals are
accepting the new stents at a rate similar to their acceptance of other new cardiac
devices and treatments” (47%)

WIL1338 writes, “Adaptation takes time. Any new therapy needs time to get
accepted. Enough data will help to convince, but medical professionals need time to
absorb information and adapt. Apart from that, hospitals require debate on their
purchasing policies, and the same applies for insurance with regard to
reimbursement.”

DJA1158 writes, “Limiting factor is not doctors it is payors; but with Medicare
agreeing to pay, the new technology has a great head start in the market place.”

EBE8160 writes, “Until further clinical information is available from independent
sources, there is likely to be no real change in the acceptance rate or utilization of
these devices.”

FER6435 writes, “Patients are already aware of the lower closure rate of these
stents. If it continues to pan out the word will rapidly spread. Patients' needs still
count. Doctors still listen to them. The HMOs have learned some lessons already
about withholding superior treatments.”

MOJ6686 writes, “Physicians may be initially resistive but I think this will be
countered by increased patient demand/desires as they hear about and become
educated about the improved outcomes.”

SGO4526 writes, “Cost/benefit ratio to be determined. Insurance will always balk at
higher costs until the evidence is overwhelming. At that point, the cost of failures
plus litigation risk tilt in the balance of the more expense procedure.”

WAL7128 writes, “Cardiologists will have to balance their desire to use a promising
new treatment against the caution of a new treatment with limited experience in
humans. Since uncoated stents are still a very viable intervention treatment,
cardiologists don't have to rush to judgment to adopt the use of coated stents.
Doctors will also be heavily influenced by reimbursement practices.”

GOL8321 writes, “There seems to be a lot of confusion not solely from standpoint of
costs -- but more importantly from legal standpoint. Will they get sued if they don't
opt for the more expensive and effective stent?”

MIK3319 writes, “We are trying to be selective as to who we use these on, limiting
them to lesions that are more inclined to restenose (LAD) or to areas that have
Copyright ©2003 ChangeWave Research
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ChangeWave Research: Golden Age of Cardiac Care
restenosed already.”

GAR6917 writes, “Hospitals are pressuring physicians to temper their use of eluting
stents for inpatients as hospital reimbursement would be based on admitting
diagnosis (DRG) rather than on actual costs incurred. For hospitalized patients it's a
loser for hospitals trying to make a dollar.”
c. Members Who Said: “Physicians and health care professionals are somewhat
skeptical of claims by manufacturers, and acceptance of coated stents will be
slower than that of other new cardiac devices and treatments” (2%)

JBU7649 writes, “There are some serious adverse events that are occurring with the
coated stents. These things happen when a new therapy opens up to include the
entire population. A prudent surgeon will go slowly with this new therapy, waiting to
learn some information from outcome trials over the longer term.”
(3) Question Asked: Are patients actively inquiring about the new coated stents?
Yes
56%
No
12%
Don't Know 32%
Patients are Anxious to Learn About the New Stents. By better than a 4-to-1
margin (56% vs. 12%) respondents said patients are eagerly seeking information about
the new drug-eluting stents.
(4) Question Asked: Patient opinion often affects treatment procedures. Do you
believe current patient knowledge about the new coated stents is adequate
enough that a significant number of patients (i.e., 20%+) will be asking for the new
stents over the next 12 months?
Current Previous
Survey
Survey
Aug 2003 Feb 2003
Yes
No
Don't Know
44%
39%
18%
50%
40%
10%
Patient Education has Room to Improve. By 44% to 39% respondents believe
enough patients are "in the know" that at least 20% will be asking about new coated
stents during the coming year. Surprisingly, the margin has tightened since our
February 2003 survey, when we asked this same question.
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ChangeWave Research: Golden Age of Cardiac Care
B. Implantable Cardiac Defibrillators (ICDs)
(1) Question Asked: Will Implantable Defibrillators continue to grow in terms of
usage by new patient populations, or will their growth slow over the next year?
They will continue to grow in usage by new patient populations
Their growth in usage by new patient populations will begin to slow over the
next year
Their growth in usage by new patient populations will slow appreciably in the
next year
Don’t Know
59%
12%
4%
24%
Implantable Defibrillator Usage Will Continue to Grow. By close to a 6-to-1 margin
(59% vs. 12%), respondents said ICD usage will continue to expand – thanks to
increasing usage by new patients.
(2) Question Asked: Medicare granted new reimbursement rates for the use of
Implantable Defibrillators for a new patient population earlier in the year. The
population was smaller than anticipated by some. Do you believe Medicare will
expand the target patient population for Implantable Defibrillators within the next
12 months?
Yes
28%
No
30%
Don’t Know 42%
But Will Medicare Increase the ICD Patient Population in the Year Ahead?
Respondents were evenly split (28% vs. 30%) over whether Medicare will expand target
patient populations for ICDs during the coming year.
(3) Question Asked: It is fairly common industry practice for insurance
companies to provide reimbursement rates and guidelines similar to Medicare's.
In the case of Implantable Defibrillators, however, that could prove expensive
given the cost of these devices and the procedures required to put them into a
patient.
Do you think insurance companies will follow Medicare's lead on Implantable
Defibrillators, and provide similar reimbursement rates and guidelines?
Yes, they will follow Medicare's lead and provide similar reimbursement rates and
guidelines
Yes, they will follow Medicare's lead, but will pay for use of these devices in patient
populations smaller than currently covered by Medicare
Yes, they will follow Medicare's lead, but they will pay for use of these devices in
patient populations larger than currently covered by Medicare
No, they will not follow Medicare's lead
Don't Know
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51%
23%
6%
4%
17%
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ChangeWave Research: Golden Age of Cardiac Care
Insurance Companies Will Track Medicare on ICDs. One-half (51%) of respondents
expect insurance companies to follow Medicare's lead on ICDs and provide similar
reimbursement rates and guidelines. Another three-in-ten (29%) agree insurance
companies will track Medicare, but most of this group (23 percentage points) envision
payments for ICDs in patient populations smaller than currently covered by Medicare,
while far less (6 percentage points) anticipate patient populations larger than currently
covered by Medicare.
(4) Question Asked: Among the companies that serve the Implantable Defibrillator
market are Medtronic, Guidant and (by year-end) St. Jude Medical. These
manufacturers are all increasing their sales forces to support the sale of
implantable defibrillators.
Do you see any major differences between the implantable defibrillators
manufactured by each of these companies, or is their sale solely determined by
the ability of each company's sales force to educate and support physicians in
using their device?
Current Previous
Survey
Survey
Aug 2003 Feb 2003
There are major differences between the various devices on the
market
Sales are solely determined by the ability of each company's sales
force to educate and support physicians in using their device
Don't Know
No Answer
12%
11%
45%
31%
42%
2%
53%
5%
Salesmanship and Support Provide Winning Edge in ICD Market. When asked
about factors that determine success in the ICD market, 45% of respondents said sales
are solely achieved by educating customers and supporting physicians who use the
devices. Alternatively, only 12% see major differences between the various ICDs on the
market.
(5) Question Asked: Who do you believe is the vendor most associated with
implantable defibrillators?
Current
Previous
Survey Aug Survey
2003
Feb 2003
Guidant
Medtronic
St. Jude Medical
Don't Know
12%
56%
6%
26%
17%
51%
1%
30%
Medtronic is Top Brand in ICDs. Medtronic (56%) is easily the most recognized
brand in the implantable defibrillator market today, according to our respondents,
followed by Guidant (12%) and St. Jude Medical (6%).
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ChangeWave Research: Golden Age of Cardiac Care
(6) Question Asked: There are several other new devices on the market that are
hybrids of pacemakers and implantable defibrillators. When pacemakers need to
be replaced, do you see such hybrid pacemaker/defibrillator devices as the
product of choice if the replacement falls within Medicare treatment guidelines?
Current Previous
Survey
Survey
Aug 2003 Feb 2003
Yes, new hybrid pacemaker/defibrillator devices will routinely be
used to replace pacemakers if they fall within Medicare guidelines
No, pacemakers will still be used to replace pacemakers
Don't Know
No Answer
53%
60%
15%
25%
7%
16%
22%
2%
New Hybrid Devices on Track to Supplant Pacemakers. Fifty-three percent (53%)
of respondents believe hybrid devices (pacemaker and defibrillator) will steadily replace
pacemaker-only units, as long as these new devices are covered under Medicare. Only
15% expect new pacemakers will continue to replace old ones.
C. Other Cardiac Devices and Treatments
(1) Question Asked: Triage BNP - a cardiac test created by BioSite - has been
doing well in the marketplace. Have you heard of this cardiac test?
Yes
28%
No
60%
Don't Know 11%
No Answer
2%
(1A) Question Asked: There are rumors that Bayer and Roche will enter the Triage
BNP cardiac testing marketplace with their own "me-too" products. Assuming the
new products are competitive with the existing Triage BNP test, do the Roche or
Bayer brands matter enough to displace sales of Triage BNP?
(n=28)
Yes
57%
No
4%
Don't Know 36%
No Answer
4%
Big Brands Flexing the Muscle. The modest brand recognition (28%) of BioSite's
Triage BNP cardiac test could prove to be a problem for the company, since big
pharmas may soon enter the market. By a 57% to 4% margin, respondents said big
brand challengers would have enough impact to hurt sales of Triage BNP.
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ChangeWave Research: Golden Age of Cardiac Care
(2) Question Asked: Finally, there are a host of new diagnostic tests and devices
for various phases and aspects of cardiac disease. Please name the new
diagnostic device/test you feel is most likely to be both an important addition to
cardiac care and well accepted in the marketplace:
(n=30)
Heart Scans
Nuclear Tests
C-Reactive Protein (CRP) Tests
Cholesterol and Blood Tests
Cardiac Support Devices
BNP Tests
Other
20%
13%
13%
13%
10%
7%
24%
Best Cardiac Diagnostic Devices and Tests? When asked which cardiac diagnostic
device or test is important for patient care and enjoys solid market acceptance,
respondents chose a handful of winners. The top pick of all was Heart Scans (20%).
Nuclear Tests, C-Reactive Protein Tests, Cholesterol and Blood Tests, and Cardiac
Support Devices also received mention.
(2A) Question Asked: Why?
Sample of Alliance Member Responses
a. Heart Scans (20%)
DRB8164 writes
Diagnostic Device/Test: “Ultra fast CT scanning.”
Reason Why: "Earlier detection of cad."
NIL5788 writes
Diagnostic Device/Test: “Cardiac CT scan.”
Reason Why: “To test for the presence of coronary plaque."
MOJ6686 writes
Diagnostic Device/Test: “Heart scans.”
Reason Why: "Media advertisements to general consumer population."
JEF7065 writes
Diagnostic Device/Test: “PET/CT.”
Reason Why: “You have the ability to combine the strengths of two modalities using
fusion software to look at cardiac perfusion imaging of PET with the noninvasive
coronary angiogram of CT.”
WPW6938 writes
Diagnostic Device/Test: “EBT scanning.”
Reason Why: “Non invasive and has been proven over several years to correlate well
with other tests showing amount of coronary disease. Can also be easily repeated to
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ChangeWave Research: Golden Age of Cardiac Care
show whether efforts to decrease CAD (meds, dietary changes, weight loss, and
exercise) have had any actual effect on reducing amount of plaque in the coronary
arteries.”
STE3218 writes
Diagnostic Device/Test: “Electronic beam transmission.”
Reason Why: "Detects calcium in plaque prior to rupture. Will become more widely
available as a screening tool in addition to stress testing in both high and low risk
groups"
b. Nuclear Tests (13%)
ASH9119 writes
Diagnostic Device/Test: “Nuclear Injected Stress Test.”
Reason Why: "Cost is coming down so the equipment is showing up in cardiologists'
offices. Only hospitals could afford this equipment up to now. This will replace the Echo
Stress Test over time."
WIS5710 writes
Diagnostic Device/Test: “Nuclear testing.”
Reason Why: "Non-invasive."
JCH8588 writes
Diagnostic Device/Test: “Exercise Gated Blood Pool Scan or MUGA.”
Reason Why: “Exercise Gated Blood Pool Scan or MUGA: a nuclear scan to see how
the heart wall motion and ejection fraction with exercise when taken while the patient is
at rest.”
DR.1535 writes
Diagnostic Device/Test: “Nuclear Medicine Cardiac Scans for MI's.”
Reason Why: “Quick and fairly accurate.”
c. C-Reactive Protein (CRP) Test (13%)
BAR9865 writes
Diagnostic Device/Test: “C Reactive Protein (CRP) blood test.”
Reason Why: "A recently elevated CRP has been shown to be a strong marker for
heart attack risk. Infections raise the CRP, which makes monitoring the CRP a fairly
inexpensive way to lower the risk for MI."
BOD1855 writes
Diagnostic Device/Test: “C-reactive protein.”
Reason Why: “Recent reports have suggested that the addition of C-reactive protein to
diagnostic testing may aid in the prediction of cardiovascular risk. As an inflammatory
marker, its measurement may also help select drug therapy. C-reactive protein has
received the most press, and is involved in cardiovascular research."
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ChangeWave Research: Golden Age of Cardiac Care
BEL5152 writes
Diagnostic Device/Test: “C-reactive protein (CRP)."
Reason Why: "Old and simple test has rapidly become a standard test in cardiac
patients. CRP measures the vascular inflammatory response. Vascular inflammation is
now believed to be the underlying process driving coronary heart disease. It helps to
bridge the gap in our understanding of traditional risk factors. By this I mean it helps to
explain why some patients without the traditional risk factors such as smoking, elevated
LDL cholesterol and high blood pressure still can develop heart disease -- these
patients tend to have elevated serum CRP values. Conversely, some patients with high
risk factors don't develop heart disease -- these patients tend to have low serum CRP
levels."
ERI5582 writes
Diagnostic Device/Test: “C-Reactive Protein.”
Reason Why: “Simple, cheap."
d. Cholesterol and Blood Tests (13%)
CEN9132 writes
Diagnostic Device/Test: "Tests to determine cholesterol particle sizes, for
homocysteine."
Reason Why: "First there was test for total cholesterol. Now, many doctors agree that
total cholesterol is not nearly as important as individual HDL and LDL cholesterol
numbers. The particle size test further subdivides LDL cholesterol into groups separated
by particle sizes. The smallest particles are the most damaging to arteries. Hence, it
will be very important information for cardiologist to know. Likewise, along with high
LDL Cholesterol and high triglycerides, homocycteine is a third important risk factor for
heart disease. So, again, this would be very useful and important information for
cardiologists to know."
VIT1251 writes
Diagnostic Device/Test: “VAP.”
Reason Why: "Covers many aspects of cardiac and vessel disease with one test."
MTA6607 writes
Diagnostic Device/Test: “Genes and Enzymes related blood tests.”
Reason Why: “To target early cases."
EBE8160 writes
Diagnostic Device/Test: “Serum tests for risk factors.”
Reason Why: "Generally this will be an area of growth as more people want to know
their risks for cardiac disease, especially as there seems to be evidence that much of
this risk may be genetically determined."
e. Cardiac Support Devices (10%)
KUR3102 writes
Diagnostic Device/Test: “Cardiac support devices.”
Reason Why: “Thoratec Ventricular Assist Device system (Thoratec VAD system), an
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ChangeWave Research: Golden Age of Cardiac Care
external device for short- to mid-term cardiac support, and the HeartMate Left
Ventricular Assist system (HeartMate), an internal device for longer-term cardiac
support. Both made by Thoratec and provide maintenance for those waiting or unable
to get transplant."
LEO7024 writes
Diagnostic Device/Test: “Left ventricular assist devices."
Reason Why: “These are used in patients with congestive heart failure. Studies show
the quality of life is much better with these than the best medical therapy available.
These pt will ultimately need a cardiac transplant and will be on a waiting list much
longer than the list of hearts from donors. These devices also prolong life. They cost
$60,000 and are currently approved by Medicare and private insurance companies for
class V patients. The Medicare Advisory Committee has recommended usage in the
other four categories. Only one company is allowed to sell these for the next two years-Thoratec (THOR), and has been designated by Medicare as the gold standard for
comparison for efficacy. This will immediately benefit 250,000 Americans and
physicians will embrace this device — they already do."
ELK5836 writes
Diagnostic Device/Test: “Implantable Defibrillators."
Reason Why: "Further improvements with price reduction will result in physician,
patient acceptance (with reimbursement approval)."
f. BNP Tests (7%)
GOL8321 writes
Diagnostic Device/Test: “Triage BNP.”
Reason Why: “Because it seems the cardiologists are presently overwhelmed with the
onslaught of data being thrown at them on an ever rapidly increasing basis in this
fiercely competitive market. Anything that helps to simplify their choices would certainly
be welcome."
WJH7828 writes
Diagnostic Device/Test: “BNP (Biosite, Beckman, and Bayer) and NTproBNP (Roche
and Dade).”
Reason Why: “This testing is in its infancy. The Roche test, NTproBNP will eventually
dominate (4:1) because this is an outpatient office/clinic test primarily and the Biosite
BNP version is not stable if not performed within four hours of draw. If proBNP
dominates in the offices it will dominate in the ER and to a great extent in the hospital.
The only place for Biosite BNP is in patient's with renal failure (<10%) and in monitoring
after Natrecor infusion because the level register a change more quickly (shorter half
life)."
g. Other (24%)
HER4689 writes
Diagnostic Device/Test: "Gene Therapy."
Reason Why: "I like the non-invasive approach of gene therapy. I have recently
become interested in Coratus Genetics CAQ and its endothelial growth factor 2.
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ChangeWave Research: Golden Age of Cardiac Care
Apparently Boston Scientific does too!"
GUT8640 writes
Diagnostic Device/Test: “Non invasive arrhythmia detector.”
Reason Why: "Vicor, a private company, has a non-invasive arrhythmia detector which
will be a blockbuster product."
WAT6220 writes
Diagnostic Device/Test: “None.”
Reason Why: "None work at understanding the underlying cause of cardiac problems
and therefore focus only on symptoms. Medicine has a terrible track record on cures,
but they are quite good at playing around with symptoms."
JES5551 writes
Diagnostic Device/Test: “Self-administered, accurate and simultaneous blood
pressure/pulse rate/weight stations that give credit card storage of sequential tests.”
Reason Why: "They provide an interesting incentive to improve on one’s habits by
seeing the trend in your numbers."
BOB3328 writes
Diagnostic Device/Test: “Detection of cardiac calcium deposition.”
Reason Why: “Importance of it as a primary indicator of the level of heart attack risk.”
Summary and Analysis
Unconventional Thinking. In our February 2003 report, "Next Boom in Cardiac Care:
Stents and Defibrillators," our findings showed that ICD sales would exceed analyst
projections, while the new drug-eluting stents would launch somewhat slower than was
widely expected. Subsequent events have shown both Alliance findings to be on target.
Reaffirmation of Established Trends for ICDs and Drug-Eluting Stents. The new
coated stents are continuing to capture market share at a reasonable pace, not a
breathtaking one. But the ICD market is expanding rapidly, and the private marketplace
will follow Medicare's lead.
(A) ICD Market Continues to Thrive

By nearly a 6-to-1 margin (59% vs. 12%), respondents believe ICD use will continue
to expand due to increasing usage by new patients.

But respondents were split (28% vs. 30%) over whether Medicare will expand target
patient populations for ICDs in the coming year.

One-in-two respondents (51%) expect insurance companies to follow Medicare's
lead on ICDs and provide similar reimbursement rates/guidelines.

45% believe ICD sales are solely achieved by educating customers and supporting
physicians who use the devices.
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ChangeWave Research: Golden Age of Cardiac Care

53% of respondents believe hybrid devices (pacemaker and defibrillator) will steadily
replace pacemaker-only units, as long as these new devices are covered under
Medicare.

Regarding companies, Medtronic (56%) is easily the most recognized brand in ICD
market, followed by Guidant (12%) and St. Jude Medical (6%).
(B) New Coated Stents are Doing Solid, but Not Yet Stellar

72% of respondents expect a "Rapid" or "Dramatic" adoption rate of 25% or more for
drug-eluting stents over the next 12 months.

But while 41% see rapid physician acceptance, 47% see physicians adopting these
devices at a rate typical for any new cardiac device.

By a 56% to 12% margin, respondents said patients are eagerly seeking information
about the new drug-eluting stents. This indicates a swift acceptance might be
tempered by moderating factors (i.e. reimbursement issues).

By a 56% to 12% margin, respondents said patients are eagerly seeking information
about the new drug-eluting stents.
Other Cardiac Diagnostics and Treatments. Cardiac scanning technology is
emerging as a major growth area, while BioSite's Triage BNP appears to be heading for
a serious challenge from big pharma competitors.

Cardiac scanning technology is emerging as a major growth area. When asked
which cardiac diagnostic device or test is important for patient care and enjoys solid
market acceptance, the top pick of all was Heart Scans (20%). In addition, Nuclear
Tests, C-Reactive Protein Tests, Cholesterol and Blood Tests, and Cardiac Support
Devices also received mention.

BioSite's Triage BNP cardiac test has a modest 28% brand recognition, which may
pose problems as it appears headed for a serious challenge from big pharma
competitors. By a 57% to 4% margin, respondents said big pharma challengers
would have enough impact to hurt sales of Triage BNP.
Bottom Line: The key trends we first uncovered in our February 2003 survey –
stronger than expected ICD sales and a steady but not yet stellar rise in market share
for coated stents – will continue to shape these markets at least through mid-2004.
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ChangeWave Research: Golden Age of Cardiac Care
III. ChangeWave Research Methodology
This report presents the findings of an August 19-25, 2003 survey of Alliance
Healthcare members to learn more about new trends in cardiac devices and treatments.
A total of 101 members participated in the survey.
The Alliance’s proprietary research and business intelligence gathering system is based
upon the systematic gathering of valuable business and investment information directly
over the Internet from accredited members.
ChangeWave surveys its Alliance members on a range of business and investment
research and intelligence topics, collects feedback from them electronically, interprets
and reconciles the information in a cohesive manner and converts the information into
valuable quantitative and qualitative reports.
The Alliance has assembled its membership team from senior technology and business
executives in leading companies of select industries. Nearly 3 out of every 5 members
(58%) have advanced degrees (e.g., Master’s or Ph.D.) and 94% have at least a fouryear bachelor’s degree.
The business and investment intelligence provided by the Alliance provides a real-time
view of companies, technologies and business trends in key market sectors, along with
an in-depth perspective of the macro economy – well in advance of other available
sources.
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ChangeWave Research: Golden Age of Cardiac Care
IV. About ChangeWave Research
ChangeWave Research, of Phillips International, Inc. is a market research intelligence
network powered by thousands of accredited and organized front-line professionals –
the ChangeWave Alliance.
ChangeWave is the alternative to traditional “sell-side” investment research. The
company publishes ChangeWave Investing, the investment advisory service for
individual investors dedicated to researching and discovering growth stocks that profit
from radical change, and Weekly WaveWire, a free e-mail newsletter distributed to
nearly 200,000 investors.
ChangeWave has a very unique asset in its 4,000-member Alliance. We have
assembled our membership team from a broad cross section of more than 20 vertical
markets such as Internet e-commerce, semiconductors, data storage, and
biotechnology, along with a wide range of professional disciplines including CIOs, IT
managers, executive management, scientists, engineers and sales personnel.
The ChangeWave Alliance is composed of senior technology and business executives
in leading companies – credentialed professionals who spend their everyday lives
working on the frontline of technological change.
ChangeWave Research Reports provide a real-time view of companies, technologies
and business trends in key market sectors along with an in-depth perspective of the
macro economy – well in advance of other available sources. ChangeWave surveys its
4,000 Alliance members on a wide range of investment research topics and converts
the findings into valuable investment and business intelligence reports. ChangeWave
delivers its products and services on the Web at
ChangeWave Research does not make any warranties, express or implied, as to
results to be obtained from using the information in this report. Investors should
obtain individual financial advice based on their own particular circumstances
before making any investment decisions based upon information in this report.
For More Information:
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USA
Telephone: 301-279-4200
Fax: 301-610-5206
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