Jarvik 2000 FlowMaker® CE Mark Approved In Europe

The Jarvik 2000 is a thumb-sized titanium pump implanted inside the weakened, failing heart to boost its output of blood to the body. For the past five years, the Jarvik 2000 has been used to treat over 100 heart failure patients worldwide. It has had high rates of success both as a bridge to transplant and for lifetime use.

The CE Mark applies to the Jarvik 2000 both as a bridge-to-transplant and lifetime-use treatment, an important development in the availability of heart assist devices to the public. Now, severe heart failure patients and their doctors in Europe can choose the Jarvik 2000 as an intervention before the disease takes an irreversible toll on patients' bodies and other organ systems. The Jarvik 2000 will be used more often with patients who are outpatients at the time the decision is made to implant the device. Earlier treatment is expected to benefit patients' health, quality of life, and chances of survival.

The Jarvik 2000 FlowMaker has given extremely sick patients a near normal quality of life; it has shown low rates of infection, compared to other approved LVADs; and it has had no mechanical bearing failures to date. Its external components, including the battery and pump controller, are rugged and ultra-portable, weighing about a kilogram. The implanted device itself weighs only 90 grams and slips inside the left ventricle, allowing the heart to continue to fill with and eject blood. With their natural heart intact, Jarvik 2000 patients do not feel the device at work, they retain a pulse, and they often have recovery of their own heart to some degree. Their quality of life approaches the ideal for this type of mechanical circulatory support device: "forgettable" use by the patient.

The difference between the bridge-to-transplant and lifetime-use models of the Jarvik 2000 is in how the driveline for the device is connected to its external battery and controller. For lifetime use, the driveline is routed through a titanium connector mounted behind the ear, a design that borrows from cochlear implants which have been used infection-free in individual patients for more than 20 years. The first patient to receive the Jarvik 2000 for lifetime use is active and in good health almost five years after implantation. He is the longest surviving patient in the world continuously supported by any type of mechanical heart. Many other Jarvik 2000 patients are surviving up to five years following implant of the mechanical heart and subsequent transplant.

JARVIK HEART will soon be seeking to partner with exceptional medical centers throughout the European Union to make the Jarvik 2000 FlowMaker available to the patients who can most benefit from it.

JARVIK HEART, Inc. (http://www.jarvikheart.com/) 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.

CONTACT: Robert Jarvik of JARVIK HEART, M.D., +1-212-397-3911, ext. 10

Web site: http://www.jarvikheart.com/