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Abbott Advances Its Revolutionary Fully Bioabsorbable Drug Eluting Stent With Initiation of Next Phase of Clinical Trial
Date:3/24/2009

ing a MACE rate of 3.6 percent (one patient) at two years. MACE is a composite clinical measure of safety and efficacy outcomes, defined as any event that resulted in re-treatment of the treated artery lesion (ischemia-driven target lesion revascularization), heart attack (myocardial infarction) or cardiac death.

"Based on the strong clinical outcomes from the first stage of Abbott's bioabsorbable device trial, interventional cardiologists have been eager to enroll their patients into the second stage of the trial," said John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator in the ABSORB trial. "If the bioabsorbable stent continues to perform well in this trial and subsequent larger trials with more complex narrowings, bioabsorbable device technology may become the new standard of care for patients with coronary artery disease."

Abbott is the only company with long-term clinical data (out to two years) evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent. Abbott's bioabsorbable everolimus eluting coronary device is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. As with a metallic stent, Abbott's bioabsorbable device 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 device is designed to be slowly metabolized by the body and completely absorbed over time.

"Abbott has been on the front lines of innovation in stent technology, and the fully bioabsorbable device is on track to become a clinical reality for patients," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Abbott is the furthest ahead in its clinical programs to bring a bioabsorbable drug eluting device to patients, and the company is com
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