Abbott Announces Positive Six-Month Results From the World's First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent

Abbott's Bioabsorbable Stent Technology Holds Promise as Future-Generation

Treatment Option for Physicians Treating Patients with Coronary Artery


Mar 24, 2007, 01:00 ET from Abbott

    ABBOTT PARK, Ill., March 24 /PRNewswire-FirstCall/ -- Abbott today
 announced positive results from ABSORB, the world's first clinical trial
 evaluating the overall safety and performance of a fully bioabsorbable
 drug- eluting stent platform for the treatment of coronary artery disease.
 Six- month results from the first 30 patients in the trial, presented at
 the 56th Annual American College of Cardiology Scientific Session in New
 Orleans, demonstrated no stent thrombosis and a low (3.3 percent)
 hierarchical rate of ischemia-driven Major Adverse Cardiac Events (MACE),
 such as heart attack or repeat intervention.
     "The encouraging results from the first 30 patients of ABSORB suggest
 that drug-eluting bioabsorbable stent technologies may be a promising
 future therapy option for physicians treating patients with heart disease,"
 said Patrick W. Serruys, M.D., Ph.D., professor of interventional
 cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, who
 is co-principal investigator of the study. "A drug eluting stent that would
 eventually disappear after restoring blood flow is an exciting concept that
 we look forward to further exploring."
     The single MACE event reported was a non-Q-wave myocardial infarction.
 The same patient underwent a repeat intervention that occurred at the site
 of the original procedure, resulting in an overall target lesion
 revascularization rate of 3.3 percent. The trial results confirmed that the
 treatment effect of everolimus in the bioabsorbable stent is similar to
 that observed in Abbott's studies of metallic drug-eluting stents, with
 everolimus actively inhibiting tissue growth into the artery. The rate of
 device success (successful placement of the bioabsorbable stent at the site
 of the lesion) was 93.5 percent.
     Abbott's everolimus-eluting 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, the
 bioabsorbable stent is designed to restore blood flow by propping the
 vessel open, providing support until the blood vessel heals. Unlike a
 metallic stent, a bioabsorbable stent is designed to be slowly metabolized
 by the body and completely absorbed over time.
     "Based on these encouraging safety results, Abbott will continue to
 advance this technology by enrolling the next cohort of patients in the
 ABSORB study in Europe and New Zealand," said John M. Capek, Ph.D., senior
 vice president, Abbott Vascular. "The next phase of the ABSORB study will
 utilize a next-generation bioabsorbable everolimus-eluting stent that
 incorporates several advancements designed to improve strength and
     About the ABSORB 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 and stent thrombosis (blood clot formation)
 rates -- 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.
 Other key endpoints of the study include follow-up measurements assessed by
 angiography, IVUS, and state- of-the-art imaging modalities at 180 days and
 two years, as well as a new noninvasive technique in a subset of patients
 at 18 months. The co-principal investigator of the study is John Ormiston,
 M.D., of Mercy Hospital in Auckland, New Zealand.
     For images of Abbott's bioabsorbable stent and other information,
 please visit the company's online ACC newsroom at .
     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.
     About Abbott
     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
     Abbott's news releases and other information are available on the
 company's Web site at .