Healthcare Industry News: ABSORB trial
News Release - October 22, 2007
Abbott Announces Positive One-Year Results from the World's First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary StentOne-Year Data on First 30 Patients Enrolled in Ongoing Study Presented at TCT
WASHINGTON, Oct. 22 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) today announced continued 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. One-year results from the first 30 patients in the trial demonstrated no stent thrombosis and a low major adverse cardiac event (MACE) rate at 12 months (1 patient, 3.4%, n=29), with no additional MACE, including no re-treatment of a diseased lesion (ischemia-driven target lesion revascularization) since six months for patients who received a bioabsorbable stent. The overall MACE rate in the ABSORB trial at six months was 3.3%, as previously announced in March 2007. The results were presented today at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"We continue to see consistent positive data from consecutive patient follow-up in the ABSORB trial," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. "Abbott's bioabsorbable coronary artery stent technology has maintained initial safety and effectiveness results in patients out to one year."
Abbott is the only company with a bioabsorbable drug eluting coronary stent in clinical trials. Abbott's bioabsorbable everolimus eluting coronary 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 to 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.
As reported in March 2007, late loss, a measure of reduction in lumen (vessel) diameter after stenting, was 0.44 mm for ABSORB at six months.
"ABSORB is an exciting future generation device that has the potential to advance the treatment of coronary artery disease beyond the benefits that next-generation metallic drug eluting stent platforms can provide," said John M. Capek, PhD., executive vice president, Medical Devices, Abbott. "Positive data with Abbott's bioabsorbable technology is encouraging and supports the direction we are moving toward in helping physicians open blocked arteries with stents, while also allowing the stent itself to disappear over time."
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 (defined as any event that resulted in re-treatment of a diseased artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates -- at 30,180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug-eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.
For images of Abbott's bioabsorbable stent and other information, please visit the company's online TCT newsroom at http://www.abbottvascular.com/presskit.
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.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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