Abbott Completes Enrollment of ABSORB Trials in US, Japan, and China

April 10, 2014—Abbott Vascular (Santa Clara, CA) announced that it has completed enrollment of three randomized clinical trials to support approvals of the company’s everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) in the United States, Japan, and China. Absorb received European CE Mark approval in 2011.

In the United States, the ABSORB III randomized clinical trial has enrolled approximately 2,000 patients. The trial will evaluate the potential benefits of the Absorb BVS in patients with coronary artery disease. The primary endpoint of ABSORB III is target lesion failure (TLF), a combined measure of the safety and effectiveness in comparison to the company’s Xience family of everolimus-eluting stents at 1 year.

The ABSORB Japan and ABSORB China trials each enrolled approximately 400 patients, and the primary endpoint is TLF at 1 year and late loss at 1 year, respectively, in comparison to the Xience family of everolimus-eluting stents. The ABSORB II trial enrolled approximately 500 patients, mostly in Europe, and 1-year clinical results are anticipated later this year, stated Abbott Vascular.

In the company’s press release, ABSORB III Study Chair Gregg W. Stone, MD, commented, “The rapid completion of enrollment in the Absorb randomized trials is a testament to the interest among doctors and patients in advancing new options to treat heart disease. Absorb represents an entirely new approach to helping people with heart disease by doing the job of a metallic stent, but then disappearing after its work is done, giving people the opportunity to live their lives free of a permanent metallic device implanted in their arteries.” Dr. Stone is Director of Cardiovascular Research and Education for the Center for Interventional Vascular Therapy at Columbia University Medical Center New York-Presbyterian Hospital in New York City.

Dean J. Kereiakes, MD, a Principal Investigator of ABSORB III, added, “The medical community eagerly awaits the results of the randomized trials for Absorb. We have made tremendous progress in interventional cardiology with the advances in metallic stents. A device that could provide similar benefits but not leave behind a permanent implant has the potential to transform the way coronary artery disease is treated.” Dr. Kereiakes is Medical Director of the Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati, Ohio, and Professor of Clinical Medicine at Ohio State University.

Abbott Vascular advised that the Absorb BVS is an investigational device that is limited by United States law to investigational use and is not approved or available for sale in the United States. Absorb is authorized for sale in CE Mark countries and is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India.