NEW YORK, March 29 /PRNewswire/ -- JARVIK HEART, Inc., a developer of advanced technology for the treatment of heart failure, announced today that it has received conditional approval to begin a pivotal trial of the Jarvik 2000 FlowMaker(R) for bridge-to-transplant use. The study will enroll up to 160 patients at 25 medical centers throughout the United States. The primary endpoint of the study will be successful bridging to heart transplant or survival for six months supported by the device. Secondary endpoints will include measures of quality of life, neuro-cognitive function, and rates of serious adverse events.
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JARVIK HEART recently completed enrollment in its pilot study of the Jarvik 2000, which included 63 patients at eight leading medical centers. Many of those patients are surviving up to five years following implant of the mechanical heart and subsequent transplant. In the pilot study there have been no failures of the implanted device, and although not evaluated for statistical significance, the data suggest lower device infection rates than reported in the literature for currently FDA-approved heart assist devices (HeartMate and Novacor), and rates of thromboembolism and stroke that are approximately the same as published for the approved devices.
The Jarvik 2000 weighs only 90 grams, compared to 1200 grams for HeartMate and 1800 grams for Novacor. It is silent whereas HeartMate and Novacor produce constant noise audible to the patient and others nearby. And because the Jarvik 2000 is a true booster pump, the patient's natural heart continues to work in tandem with it. Therefore the device requires less power and achieves long battery life. These and other characteristics have been "human engineered" to provide the patient a high quality of life.
The Jarvik 2000 FlowMaker has also been used as a permanent implant in Europe. The first patient to receive the device for lifetime use is in good health nearly five years following his surgery, and is the longest surviving patient in the world continuously supported by any type of artificial heart. On April 7th, the inventor of the artificial heart, Dr. Robert Jarvik, will interview that patient, Mr. Peter Houghton, about his life and experiences as an historic medical pioneer. The program, which will be held at the New York Academy of Medicine, 1216 Fifth Avenue at 103th Street, beginning at 8:00 p.m., is free of charge, and will be open to the public. It will be filmed for the Smithsonian's "Project Bionics", a history of the development of artificial organs, produced in collaboration with the American Society of Artificial Internal Organs and NIH's National Library of Medicine. To register, please visit the New York Academy of Medicine Web site at http://www.nyam.org/ and go to the events calendar.
Later this year, JARVIK HEART intends to submit an application to the FDA for a pivotal study of the Jarvik 2000 for lifetime use in the United States., under a protocol designed to demonstrate its safety and efficacy for the treatment of heart failure in earlier stage patients. Using the mechanical heart earlier, before patients suffer too much damage to other organs, which commonly occurs in heart failure, is expected to help them recover more rapidly to a normal life.
JARVIK HEART, Inc. is a privately held company that develops miniaturized heart assist devices for the treatment of severe heart failure. The company, founded in 1988, is located in Manhattan. Robert Jarvik, M.D., inventor of the Jarvik 7 and Jarvik 2000 mechanical hearts, is President and Chief Executive Officer. Marilyn vos Savant, columnist for Parade magazine, is Chief Financial Officer. Leon Hirsch, founder and former Chairman of United States Surgical Corporation, serves as Chairman of the Board.
For more information, please visit http://www.jarvikheart.com/.
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http://www.newscom.com/cgi-bin/prnh/20040427/NYTU126LOGOJARVIK HEART, Inc.