NEW YORK, July 12 /PRNewswire/ -- JARVIK HEART, Inc., a developer of advanced technology for the treatment of heart failure, announced today that it has received full approval from the Food and Drug Administration (FDA) to begin a pivotal trial of its mechanical heart, the Jarvik 2000 FlowMaker(R), for bridge-to-transplant use.
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The pivotal study is designed to establish the safety and efficacy of the Jarvik 2000 in supporting severe heart failure patients while they await the availability of a donor heart for transplant. Up to 160 patients will be enrolled in the study at 25 medical centers throughout the United States. Presently, Jarvik Heart has nine trained implant centers and will add sixteen additional implant teams over the next year. In addition to the survival rate to transplant, the study will examine quality of life of the patients, and rates of serious adverse events.
The launch of the pivotal study follows completion of a pilot study of the Jarvik 2000 in the U.S., which enrolled 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. The pilot study yielded other important data, as well, including very high reliability with no failures of the implanted Jarvik 2000 and rates of infection, thromboembolism, and stroke the same or lower than those reported in the literature for currently FDA-approved heart assist devices, the HeartMate and Novacor.
The Jarvik 2000 also compares favorably with the HeartMate and Novacor in other ways. It 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 of the Jarvik 2000 FlowMaker have been "human engineered" to provide the patient a high quality of life. In Europe, the Jarvik 2000 has earned CE Mark certification for both bridge-to-transplant and lifetime use, and has been supporting its first lifetime-use patient for over five years with an excellent quality of life.
Later this year, JARVIK HEART plans 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 for the treatment of heart failure in earlier stage patients. Using the mechanical heart earlier, before patients suffer too much damage to other organs, is expected to help them recover more rapidly to a normal life.
About JARVIK HEART, Inc.
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 visit http://www.jarvikheart.com .
JARVIK HEART, Inc.