The rate of serious adverse events with the LionHeart compared favorably to the overall adverse event rate reported in the REMATCH trial. Boehmer noted that the CUBS trial of the LionHeart represented the initial experience with the device, while HeartMate had been implanted in the bridge-to-transplant application more than 2,000 times prior to the REMATCH trial.
Nearly 5 million Americans have heart failure and an estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year. Only a fraction of those are eligible for and receive heart transplants.
Currently, a Phase I U.S. trial of the device is underway. Gayle Snider, a 36-year-old man from York, Pa., was the first U.S. recipient of the Arrow LionHeart released from the hospital. He recently celebrated four months at home and five months with the left ventricular assist device. Since leaving the hospital June 24, 2003, he has gained weight and taken a trip to the beach with family and friends. Most recently, Gayle enjoyed his favorite pastime - watching car racing - at the Dover Downs racetrack where he was treated to a behind-the-scenes look at a NASCAR event. (For more information, visit www.pennstatelionheart.com)
Arrow International, Inc., of Reading, Pa., announced Friday, Nov. 7, 2003, that it received authorization from its European Notified Body, TUV Product Services of Munich, Germany, to CE-mark the Arrow LionHeart, based on the results of the European trial. The CE-mark provides authorization to market the device within the European Economic Area for permanent implantation or "destination therapy". The Arrow LionHeart is the first left ventricular assist system to receive CE-marking authorization specifically for destination therapy.
Study sites for the European trial were: The Herzzentrum NRW (The Heart Center) in Bad Oeynhausen , Germany Deutsches Herzzentru
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Contact: Valerie Gliem
vgliem@psu.edu
814-865-9481
Penn State
12-Nov-2003