Positive Results from Clinical Trial of Bioabsorbable Coronary Stent

Abbott, a global, broad-based health care company devoted to pharmaceuticals and medical products discovery, development, manufacture and marketing, recently announced positive results from ABSORB, a 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 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 re-narrowing) even further.”

The 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. However unlike a metallic stent, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.

Abbott will soon unveil an updated, bioabsorbable stent design that will be used in the next group 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 provides 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.”

For pictures of Abbott’s bioabsorbable stent and other information, visit the company’s website at www.abbottvascular.com.

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