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MPMD ENEWSLETTER
Thursday, January 29, 2009
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2909.html
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---------------------------------------------------------eNewsletter Sponsor – Materials & Processes for Medical Devices Conference
& Exposition (MPMD ’09)
http://asmcommunity.asminternational.org/content/Events/MPMD-09/
-----------------------------------------------------------The Complete Current Issue of MPMD is Now Available Online!
http://www.asminternational.org/emails/mpmdenews2009/img/amp16701p43.pdf
-----------------------------------------------------------RECORD OF THE MONTH
Each month the newsletter features a partial record from ASM’s acclaimed
database, Materials for Medical Devices, which includes a Cardiovascular
Module and an Orthopaedic Module. This month’s MPMD Record of the Month is
from the Cardiovascular Module: Intra-Aortic Balloon.
Intra-Aortic Balloon (General)
Device Category Cardiovascular – Balloons
Application
An intra-aortic balloon and control system is a device that consists of an
inflatable balloon, which is placed in the aorta to improve cardiovascular
functioning during certain life-threatening emergencies, and a control
system for regulating the inflation and deflation of the balloon. The
control system, which monitors and is synchronized with the
electrocardiogram, provides a means for setting the inflation and
deflation of the balloon with the cardiac cycle (USFDA-CFR-870.3535).
Description
The Intra-Aortic Balloon can be made from a synthetic polymer
(polyethylene) and is attached to a catheter.
Deployment Method
The IABP is a polyethylene balloon mounted on a catheter, which is
generally inserted into the aorta through the femoral artery in the leg.
The pump is available in a wide range of sizes (2.5 cc to 50 cc) that will
fit patients of any age and size. The balloon is guided into the
descending aorta, approximately 2 cm from the left subclavian artery. At
the start of diastole, the balloon inflates, augmenting coronary
perfusion. At the beginning of systole, the balloon deflates; blood is
ejected from the left ventricle, increasing the cardiac output by as much
as 40 percent and decreasing the left ventricular stroke work and
myocardial oxygen requirements. In this manner, the balloon supports the
heart indirectly. The balloon is inflated with helium, an inert gas that
is easily absorbed into the bloodstream in case of rupture. Inflation of
the balloon can be triggered according to the patient's electrocardiogram,
their blood pressure, a pacemaker (if they have one), or by a pre-set
internal rate (Texas Heart Institute, 2008).
Duration of Implantation (Typical) Long Term (Permanent)
http://products.asminternational.org/meddev/index.aspx
-----------------------------------------------------------'Lint Brush' Captures and Kills Cancer Cells in the Bloodstream
Cornell University researcher, Michael King, has developed a lethal "lint
brush" for the blood that captures and kills cancer cells in the
bloodstream. In research conducted at the University of Rochester, King
showed that two naturally occurring proteins can work together to attract
and kill as many as 30 percent of tumor cells in the bloodstream without
harming healthy cells.
The goal is to develop a tiny, implantable, tube-like device coated with
proteins that would filter out and destroy free-flowing cancer cells in
the bloodstream. Cancer cells adhere to the selectin protein on the
microtube's surface, and are exposed to the protein, TRAIL (Tumor Necrosis
Factor Related Apoptosis-Inducing Ligand), which binds to two so-called
"death receptors" on the cancer cells' surfaces, setting in motion a
process that causes the cells to self-destruct. The cancer cells are
released back into the bloodstream to die, and the device is available for
new cancer cells to enter.
Used in combination with traditional cancer therapies, the device could
remove a significant proportion of metastatic cells, and give the body a
fighting chance to remove the rest of them. The work will be published in
Bioengineering and Biotechnology; "Delivery of apoptotic signal to rolling
cancer cells: a novel biomimetic technique using immobilized TRAIL and Eselectin;" DOI: 10.1002/bit.22204.
mailto:[email protected]
http://www.news.cornell.edu/stories/Dec08/king.cancer.html
---------------------------------------------------------AGY Launches New Glass Fiber Biomaterial for Implants
AGY has launched a new biomaterial, HPB glass fiber, suitable for longterm implant applications and compatible with a wide range of
thermoplastic polymers such as PEEK, PEI and PPS. HPB glass fibers have
40% more tensile strength and a 20% higher tensile modulus than ordinary
E-Glass fibers. The material has been used successfully for dental
composite applications such as orthodontics, dental implants, crowns, and
bridges. AGY is pursuing other proprietary medical device applications
that require a biocompatible structural composite reinforcement, such as
orthopaedics.
http://www.agy.com
----------------------------------------------------------
Better Than Phelps: Hot, Golden, Swimming Nanowires Zap Cancer
Scientists at the University of Idaho are working on an innovative cancer
treatment may be hotter, covered in more gold, and even be a better
swimmer than Michael Phelps. Scientists at the University of Idaho are
engineering multifunctional and dynamic nanowires coated in gold that swim
through the bloodstream and attach to specific cancerous cells. An
electromagnetic fields heats the nanowires, destroying the cancerous
cells. The research is part of a multimillion dollar project funded by the
Korean government as part of the International Global Collaboration
Pioneer Program.
http://www.today.uidaho.edu
-----------------------------------------------------------MPMD 2009: Materials Innovations for Medical Devices
Abstract Submission Deadline Extended to February 16, 2009!
ASM International’s MPMD is the only medical devices conference and
exposition that brings together the world’s foremost experts from
academia, industry, and national laboratories involved in cardiac,
vascular, neurological and GI implants, orthopaedic implants, dental
devices, and surgical instrumentation/devices.
Sessions will focus on degradation, wear fracture, corrosion, processing,
biomimetics, biocompatibility, bioelectric phenomena and electrode
behavior, surface engineering, and cell-material interactions. Materials
covered include biomedical alloys (stainless steels, Ti alloys, Co-Cr
alloys, Ni-Ti alloys, noble and refractory metals), biopolymers,
bioceramics, surface coatings, and nanomaterials.
MPMD has the technical excellence and networking opportunities to impact
your career and the entire medical device industry. Don’t miss your
opportunity to shape what happens next!
http://asmcommunity.asminternational.org/content/Events/MPMD-09/
Can this be boxed and placed in the sidebar?
Who should attend?
- Materials scientists & engineers
- Metallurgists
- Product designers & engineers
- Research & development personnel
- Manufacturing engineers
---------------------------------------------------------Strategic Agreement to Develop Drug-Eluting Stents & Balloons
Micell Technologies has entered into a strategic agreement with Maxcor
Inc., the newly incorporated subsidiary of Opto Circuits Ltd. Micell
Technologies has obtained the rights to Maxcor’s Genius MAGIC Cobalt
Chromium Coronary Stent System for the purpose of developing and marketing
drug-eluting stents based on Micell’s prop coating technology. The stateof-the-art stent and delivery system was developed by EuroCor GmbH, a
subsidiary of Opto Circuits. The companies also entered into an agreement
to develop drug-eluting balloon products for cardiovascular applications.
http://www.micell.com
-----------------------------------------------------------Mott Porous Metal Products for Flow & Filtration
Mott Corp.’s porous metal media control gas and liquid flows in drug
delivery devices, increase instrument performance, and filter micron sized
impurities from gas and liquid streams. Porous metal products are
biocompatible, durable, and 100% recyclable. The porous metal components
can be removed from the device for cleaning and sterilizing between uses.
Mott porous metal products have been used as biocompatible porous titanium
filters, implantable devices, metal filters in test stands, spargers used
in cell-culture processes, filters to prevent plugging in catheters, and
precision flow restrictors for the delivery of gases in life-critical
systems.
http://www.mottcorp.com
-----------------------------------------------------------Japanese Ministry Approves St. Jude Medical’s Implantable Defibrillator
St. Jude Medical, Inc. has received regulatory approval from the Japanese
Ministry of Health, Labour and Welfare of its Atlas II implantable
cardioverter defibrillator (ICD), a device used to treat patients with
potentially lethal abnormal heart rhythms. An ICD is a small device
implanted in the chest to treat potentially lethal, abnormally fast heart
rhythms (ventricular tachycardias or ventricular fibrillation), which
often lead to sudden cardiac death. It delivers potentially life-saving
therapy from the device to the patient's heart through an insulated wire
or lead. The Atlas II ICD significantly enhances telemetry speed for
faster communications - up to five times faster than predecessor devices resulting in quicker, more convenient follow-up visits for patients and
physicians.
http://www.sjm.com
-----------------------------------------------------------ASM COURSE
Metallographic Techniques for Medical Devices
June 15-19, 2009, 3.0 CEUs
Save time on the calendar now for this course taught by Gabe Lucas,
metallography expert at Buehler.
Proper evaluation of medical devices presents unique challenges, and
routine materials testing methods do not work without modification or
advanced techniques. Students will prepare alloys commonly found in
medical devices under the guidance of the instructor, and they are
encouraged to bring their own specimens. The consistency and repeatability
of preparation through semi-automatic specimen preparation is discussed
and demonstrated on state-of-the-art equipment. On completion of the
course, students should be able to:
- Select proper consumables and techniques for sectioning, mounting,
grinding, polishing
- Choose the correct etchant to reveal the structure and features for the
alloy at hand
- Document structures using light optical microscopes equipped with image
capture cameras and software
- Distinguish artifacts from real structures
- Apply quantitative metallographic techniques
http://asmcommunity.asminternational.org/portal/site/www/AsmStore/ProductD
etails/?vgnextoid=1453a135c544d110VgnVCM100000621e010aRCRD
-----------------------------------------------------------Custom Manufacturing of Needles, Surgical Instruments, & Tubes
The Marshall Manufacturing Company uses the latest Swiss quality and
precision machining processes to manufacture new designs for improved
medical procedures such as laparoscopy and other minimally invasive
procedures. Straight and contoured surgical needles, tubes and rod shaped
instruments and components are custom manufactured for use in cosmetic,
orthopedic, cardiac, urological and vascular procedures. Materials include
stainless steel, titanium and most medical grade metals. Marshall
Manufacturing also provides plastic over-molding of handles and grips for
custom designed instruments.
http://www.marshallmfg.com
-----------------------------------------------------------NASA Fiber Optic System Provides Early Detection of Cataracts
Researchers from the National Eye Institute, part of the National
Institutes of Health, and NASA collaborated to develop a simple, safe eye
test for measuring alpha-crystallin, a protein related to cataract
formation. The compact fiber optic probe developed for the space program
has proven valuable as the first non-invasive early detection device for
cataracts, the leading cause of vision loss worldwide. If subtle protein
changes can be detected before a cataract develops, people may be able to
reduce their cataract risk by making simple lifestyle changes. The new
device is based on a laser light technique called dynamic light
scattering. It was initially developed to analyze the growth of protein
crystals in a zero-gravity space environment.
http://www.grc.nasa.gov
http://www.nei.nih.gov
-----------------------------------------------------------MPMD Database Releases 4th Quarter Updates
ASM International brings to your desktop a comprehensive and authoritative
set of mechanical, physical, biological response, and drug compatibility
properties for the materials and coatings used in medical implants. For
Winter 2008 update details, see
http://products.asminternational.org/meddev/index.aspx
Update Highlights
New ISO Standard
ISO 10993 Biological Evaluation of Medical Devices – Part 18: Chemical
characterization of materials
PMA/510(k) Updates
The database features all the new PMA and 510(k) approvals up to November
12th, 2008 in the Orthopaedic and Cardiovascular modules, fully integrated
for ease of searching, and linked to materials and supplier data.
New Database Functionality
A new function in the database displays a list of materials used in a
chosen device category (e.g. Spinal, Hips, Knees etc). Click here for
information about how to use it.
New or Updated Materials with Bioresponse Information
- Demineralized Bone Matrix
- Hydroxyapatite
- Hydroxyapatite, Silicon Substituted
- Hydroxyapatite/Tricalcium Phosphate
- Poly(ester urethane urea)
- Tricalcium Phosphate
- Nitinol
Producers
- 54 new producers with links to specific devices
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to persons or property as a matter of product liability, negligence or
otherwise, or from any use or operation of any methods, products,
instructions or ideas contained in the material herein.
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