Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial
By Abbott, PRNESunday, November 15, 2009
New ABSORB EXTEND Trial to Study Performance of Revolutionary Bioabsorbable Device in Approximately 1,000 Patients
ORLANDO, Florida, November 16 - Abbott (NYSE: ABT) today announced three-year data from the first 30
patients in the first phase of the ABSORB clinical trial, demonstrating that
its fully bioabsorbable drug eluting coronary stent successfully treated
coronary artery disease and was absorbed into the walls of treated arteries.
Patients in this first phase of the ABSORB trial experienced no stent
thrombosis (blood clots) out to three years and no new major adverse cardiac
events (MACE(1)) between six months and three years (3.6 percent at three
years). These results were presented at the 2009 American Heart Association's
Scientific Sessions.
To build upon the promising results of the ABSORB trial, Abbott is
initiating a large-scale trial called ABSORB EXTEND, which will enroll
approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific,
Canada and Latin America. ABSORB EXTEND is a single-arm study designed to
further evaluate the performance of Abbott's proprietary fully bioabsorbable
stent technology. The study will enroll patients with more complex coronary
artery disease and is slated to begin enrolling before the end of the year.
"Abbott's bioabsorbable stent has the potential to be a major
breakthrough for coronary artery disease patients. The data show that
patients continue to do well three years after treatment with the
bioabsorbable coronary stent," said Patrick W. Serruys, M.D., Ph.D.,
professor of interventional cardiology at the Thoraxcentre, Erasmus
University Hospital, Rotterdam, the Netherlands, and principal investigator
for the ABSORB trial. "The strong results confirm my belief that
bioabsorbable technology is the next revolution in interventional
cardiology."
Abbott also announced that patient enrollment is complete for the second
phase of the ABSORB trial. The second phase of the ABSORB clinical trial
enrolled 101 additional patients from 12 centers in Europe, Australia and New
Zealand, and incorporated device enhancements designed to improve
deliverability and vessel support.
Abbott is the only company with three-year clinical data evaluating the
safety and performance of a fully bioabsorbable drug eluting coronary stent.
Abbott's bioabsorbable everolimus eluting coronary scaffold is made of
polylactide, a proven biocompatible material that is commonly used in medical
implants such as absorbable sutures. As with a metallic coronary stent,
Abbott's bioabsorbable technology is designed to restore blood flow by
propping open a clogged vessel, and to provide support until the blood vessel
heals. Unlike a metallic stent, however, a bioabsorbable scaffold is designed
to be slowly metabolized by the body and is completely absorbed over time.
"Abbott continues to make advancements with its promising bioabsorbable
technology," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice
president, Medical Affairs, and chief medical officer, Abbott Vascular. "The
second phase of the ABSORB trial enrolled very quickly, which is a testament
to the excitement among the clinical community around the potential shown
with this technology. We look forward to starting the ABSORB EXTEND trial to
further evaluate promising attributes of our fully bioabsorbable technology
in a broader patient population."
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label), two-phase
study designed to enroll approximately 130 patients from Australia, Belgium,
Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key
endpoints of the study include assessments of safety - MACE and stent
thrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years,
with additional annual clinical follow-up for up to five years, as well as an
assessment of the acute performance of the bioabsorbable drug eluting stent,
including successful deployment of the system. Other key endpoints of the
study include imaging assessments by angiography, intravascular ultrasound
(IVUS), optical coherence tomography (OCT), and other state-of-the-art
invasive and non-invasive imaging modalities at six months, one year and two
years.
Abbott's bioabsorbable drug eluting coronary device delivers everolimus,
a drug that inhibits tissue proliferation. Everolimus, developed by Novartis
Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed
to Abbott by Novartis for use on its drug eluting stents. Everolimus has been
shown to inhibit in-stent neointimal growth in the coronary vessels following
stent implantation, due to its anti-proliferative properties.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading
vascular care businesses. Abbott Vascular is uniquely focused on advancing
the treatment of vascular disease and improving patient care by combining the
latest medical device innovations with world-class pharmaceuticals, investing
in research and development, and advancing medicine through training and
education. Headquartered in Northern California, Abbott Vascular offers a
comprehensive portfolio of vessel closure, endovascular and coronary
products.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs more than 72,000 people and markets its products in more than
130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
1. MACE is a composite measure of key efficacy and safety endpoints and
includes cardiac death, heart attack (myocardial infarction) and
ischemia-driven target lesion revascularization.
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