ABBOTT PARK, Ill., Jan. 8, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced today the initiation of the ABSORB III clinical trial in patients in the United States. This randomized, controlled trial is designed to enroll approximately 2,250 patients, the majority in the United States, and compare the performance of Abbott's drug eluting Absorb ™ Bioresorbable Vascular Scaffold (BVS) device to the company's XIENCE ™ family of drug eluting stents. The start of this trial in the United States follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India – a country with a significant and growing prevalence of heart disease. Data from the ABSORB III trial will support U.S. regulatory filings for Absorb.
Absorb, a drug eluting, fully bioresorbable vascular scaffold 1, is an innovative device for the treatment of coronary artery disease, which is a narrowing of one or more arteries that supply blood to the heart. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. Absorb works by opening a clogged vessel and restoring blood flow to the heart similar to a drug eluting metallic stent, the current standard of care. Absorb then dissolves into the blood vessel, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic implant. 1,2
Dean Kereiakes, M.D., FACC, FSCAI, medical director of The Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati, and professor of clinical medicine at Ohio State University, was one of the first physicians to enroll a patient into the ABSORB III trial. "The deliverability of the Absorb device is impressive and similar to a best-in-class drug eluting stent," said Dr. Kereiakes, who is a co-primary investigator of the ABSORB III trial. "Absorb combines the unique attributes of a dissolvable material with the established MULTI-LINK stent design, making the scaffold flexible and conformable to the vessel."
The ABSORB III clinical trial is designed to evaluate potential benefits of Absorb in patients with coronary artery disease. Unlike a permanent metallic stent, preliminary evidence of natural vessel function suggests that treatment with an Absorb BVS could provide important clinical benefits.