Press Release
Abbott Announces Positive Three-Year Data on Its Fully Bioabsorbable Stent Technology, Initiates Large-Scale International Trial
New ABSORB EXTEND Trial to Study Performance of Revolutionary Bioabsorbable
Device in Approximately 1,000 Patients
November 16, 2009
Orlando, Florida — 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 (MACE1) 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 (NYSE: ABT)
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.
| 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. |
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
John Thomas
Tina Ventura |
(847) 938-2655
(847) 935-9390 |
