Jarvik Heart has received European approval for its Jarvik 2000 FlowMaker, a tiny left-ventricular assist device (LVAD) used to treat severe congestive heart failure. 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.
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. Doctors treating severe heart failure patients can use 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 company claims 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. The implanted device is placed inside the left ventricle, allowing the heart to continue to pump blood.
The company revealed it would soon be seeking to partner with medical centers throughout Europe to make the Jarvik 2000 FlowMaker available to the patients who can most benefit from it.
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