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Abbott Laboratories

Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial

Orlando, Florida, November 16 (ots/PRNewswire)

- New ABSORB EXTEND Trial to Study Performance of Revolutionary
Bioabsorbable Device in Approximately 1,000 Patients
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.

Contact:

Media, Jonathon Hamilton, +1-408-845-3491, or Jennie Kim,
+1-408-845-1755, or Financial, John Thomas, +1-847-938-2655, or Tina
Ventura, +1-847-935-9390, all of Abbott

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