Abbott initiates ABSORB BVS device clinical trial in coronary artery disease

Abbott (NYSE: ABT) announced today that the first patient in Japan has been treated with the ABSORB™ bioresorbable vascular scaffold (BVS) as part of the ABSORB EXTEND clinical trial. Abbott's BVS restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant. The device received CE Mark approval in the European Union (EU) for the treatment of coronary artery disease and is under clinical investigation in several countries around the world. The first patient in Japan was treated in the ABSORB EXTEND clinical trial by Shigeru Saito, M.D., director, Cardiology and Catheterization Laboratories, and vice president, Shonan Kamakura Hospital, Kanagawa, Japan.

"Abbott's BVS technology has the potential to open up a new therapy option for physicians treating patients with coronary artery disease in Japan," said Dr. Saito. "For Japanese patients, this technology will hold tremendous appeal, as it is designed to treat a clogged blood vessel like a drug eluting stent and then dissolve, thereby restoring a more natural vessel function without leaving a permanent metallic implant behind in the body. Our hope is that our participation in the ABSORB EXTEND trial will be a meaningful contribution toward making this innovative technology available to patients in Japan."

Abbott's BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. Because a permanent metallic implant is not left behind, a vessel treated with the BVS device may ultimately have the ability to move, flex, pulsate and dilate. Restoration of these naturally occurring vessel functions is one of the features that makes Abbott's BVS a significant innovation for patients in the evaluation and treatment of coronary artery disease. In addition, continuing research will show whether the need to administer long-term dual anti-platelet therapy to patients is necessary once the temporary scaffold is metabolized.

"Abbott is focused on developing revolutionary bioresorbable drug and device combination products that have the potential to change the way physicians practice medicine, and improve outcomes for their patients," said Robert Hance, senior vice president, vascular, Abbott. "The enrollment of the first Japanese patient in the global ABSORB EXTEND trial is a significant milestone and an important contribution to evaluating this technology in patients with heart disease in Japan."



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