Abbott Announces Positive Nine-Month Results from the World's First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
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- Published on Thursday, 24 May 2007 04:00
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BARCELONA, Spain | May 22, 2007 | Abbott today announced positive results from ABSORB, the world’s first clinical trial evaluating the safety and performance of a fully bioabsorbable drug eluting stent platform for the treatment of coronary artery disease. Nine-month results from the first 30 patients in the trial, presented today at the EuroPCR meeting, demonstrated no stent thrombosis and a low (4.0 percent, one patient) rate of Major Adverse Cardiac Events (MACE), such as heart attack or repeat interventional medical treatment. The results confirm the six-month findings from ABSORB, which were announced in March 2007, and show no new adverse events between six and nine months.
"These ABSORB nine-month data reaffirm the positive results we saw with Abbott's bioabsorbable stent system at six months," said ABSORB investigator Dariusz Dudek, M.D., Jagiellonian University in Krakow, Poland. "As we continue the ABSORB trial, we look forward to evaluating an updated version of the stent system designed to deliver additional support to the arterial wall and with the potential to reduce late lumen loss (vessel renarrowing) even further."
Abbott's everolimus eluting bioabsorbable stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and provide support until the blood vessel heals. Unlike a metallic stent however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.
At the EuroPCR meeting, Abbott will unveil an updated, bioabsorbable stent design that will be used in the next cohort of patients enrolled in the ABSORB trial. The new stent features improved radial strength, which is intended to maintain vessel expansion so blood can flow through.
"Not only is the ABSORB trial beginning to show that bioabsorbable technology, when applied to coronary stents, can work – it can also provide a foundation for future interventional medical innovation," said John M. Capek, Ph.D., senior vice president, Abbott Vascular. "Five years ago, the technology and 'know-how' to make a fully functioning bioabsorbable drug eluting stent didn't exist, but every success in the ABSORB trial brings us one step closer to providing this important new treatment option to physicians for their patients."
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. Key endpoints of the study include assessments of safety; MACE and stent thrombosis (blood clot formation) rates at 30, 180 and 270 days, with an annual follow-up for up to five years, and successful deployment of the bioabsorbable drug eluting stent. Other key endpoints of the study include follow-up measurements assessed by X-ray angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.
In March, six-month results from the first 30 patients in the ABSORB trial were presented at the American College of Cardiology conference, demonstrating no stent thrombosis and a low (3.3 percent, one patient) of Major Adverse Cardiac Events (MACE), such as heart attack or repeat interventional medical treatment.
For images of Abbott’s investigational bioabsorbable stent and other information, please visit the company’s online newsroom at www.abbottvascular.com/europcr.
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 that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
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 65,000 people and markets its products in more than 130 countries.