Initial Results Reported from Fully Bioabsorbable Drug-Euting Coronary Stent Trial

 

October 26, 2006

Early clinical results from Abbott's ongoing ABSORB clinical trial, the world's first study to evaluate the safety and performance of a fully bioabsorbable drug-eluting stent platform for the treatment of coronary artery disease in humans, were presented during the 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. Initial results for the first 30 patients in the trial demonstrated no MACE (Major Adverse Cardiac Events, such as heart attack) and no stent thrombosis at 30 days for patients who received a bioabsorbable everolimus-eluting stent.

Abbott's bioabsorbable drug-eluting stent is made of polylactic acid, which is designed to be fully absorbed and slowly metabolized by the coronary artery. The everolimus-coated stent will release the drug into the artery and then slowly absorb over time. The goal is to leave a healed natural vessel behind.

"We are highly encouraged by these initial results from the ABSORB trial," said John Ormiston, M.D., Auckland City Hospital, New Zealand, and co-principal investigator of the study. "We are eager to explore Abbott's bioabsorbable technology as a potential clinical option for the treatment of coronary artery disease."

The ABSORB trial is designed to assess safety and performance of Abbott's bioabsorbable everolimus-eluting stent in the treatment of patients with single de novo, native coronary artery disease or untreated lesions. Everolimus has been shown to reduce tissue growth in the coronary vessels following stent implantation.

"Bioabsorbable technology holds great potential for many vascular applications," said John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. "We intend to use the data from the ABSORB trial to study and develop therapies that can better serve physicians and their patient. Abbott's support of this study further demonstrates the depth of our vascular pipeline and illustrates our commitment to investing in future technologies."

The ABSORB trial is a prospective, non-randomized (open label) study and has been designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. The key endpoints of the study include an assessment of the safety (MACE and stent thrombosis rate) 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. Additional endpoints of the study include angiography and intravascular ultrasound (IVUS) follow-up at 180 days and two years.

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