Abbott Presents Positive Three-Year Data On Bioabsorbable Stent Technology

Published: 17-Nov-2009

Initiates large-scale international trial

Abbott has 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 out to three years and no new major adverse cardiac events (MACE1) between six months and three years (3.6% at three years). These results were presented at the 2009 American Heart Association's Scientific Sessions.

Abbott is also 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 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'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.

Charles Simonton, divisional vice president of medical affairs and chief medical officer at Abbott Vascular, said: "Abbott continues to make advancements with its promising bioabsorbable technology. 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."

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