MDNews - Minnesota

++++++++++++++++++++++++++++ + + ++++++++++++++++++++++++++++ VASCULAR SPOTLIGHT +++ +++ IMPROVING VASCULAR ABBOTT'S INVESTIGATIONAL VASCULAR PRODUCTS OF THE FUTURE, THE MITRACLIP SYSTEM AND THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS), CONTINUE TO SHOW PROMISE BASED ON NEW RESEARCH DATA. A BBOT SHARED NEW data on its MitraClip system and the ABSORB BVS at the 23rd annual Transcatheter Cardiovascular Therapeutics scientifi c symposium, held November 7–11 in San Francisco, CA, building evidence of these innovative products' efficacy to help cardiac patients without surgery. MitraClip System Mitral regurgitation (MR) — leaking or ineffective closure of mitral valve leaflets — affects people worldwide and is the most common heart valve insuffi ciency in the United States and the second-most common in the E.U. If left untreated, MR can burden the heart and lungs and lead to conges- tive heart failure, irregular heartbeat, progressive myocardial injury, stroke and sudden death. Conventional surgery — the "Alfi eri Stitch," pioneered in the 1990s by Ottavio Alfieri, M.D. — sutures the mitral leafl ets, allowing blood fl ow to the left ventricle from the left atrium, as well as proper closure of the valve when blood is pumped to the rest of the body from the left ventricle. The MitraClip is delivered via catheter through the femoral vein, making it an excellent solution for patients at risk for conventional surgery. The MitraCl ip system is the fi rst percutaneous va lve repa i r system in the world. The procedure is per- formed under general anesthesia without the need for a heart-lung machine, and patients recover in as many as three days. The MitraClip is an investigational device in the United States, and Abbott is seeking approval from the U.S. Food and Drug Administration. It received its CE Mark in March 2008 and was temporarily recalled in May 2011 due to complications caused by the catheter-based delivery system, not the device itself. ABSORB BVS Conventional percutaneous treatment of coronary artery disease leaves the wire mesh stents in place indefi nitely. The investigational ABSORB BVS restores blood flow and provides support to arteries for approximately two years before dissolving. The ABSORB BVS is made of material used in dissolvable sutures and allows natural vessel functions to be restored after two years. Abbott received CE Mark for the product in January 2011 and is the only company with fi ve-year clinical data evaluating the performance and safety of this technology. The ABSORB trial enrolled 131 patients from Belgium, Denmark, France, the Netherlands, Australia and New Zealand. With 18-month data on its ABSORB trial — 101 patients in the second stage — and fi ve-year data from the ABSORB trial — 30 patients in the fi rst stage — Abbott has reported no cases of blood clots, cardiac death or ischemia-driven target lesion revascularization related ABSORB BVS's use. The major adverse coronary event rate was 3.4% at fi ve years, with no new events in patients enrolled in the fi rst phase of the trial after the fi rst six months. ■

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