Jarvik 2000 FlowMaker CE Mark Approved in Europe

Jarvik Heart, a developer of advanced technology for the treatment of heart failure, announced it has received CE mark certification for the 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. The company said the Jarvik 2000 FlowMaker has given extremely sick patients a nearly normal quality of life, shown low rates of infection compared to other approved LVADs, and had no mechanical bearing failures to date.

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. 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.