The pivotal trial will be a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The DuraHeart LVAS is a third generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It is currently said to be the only CE marked implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing reliability and minimizing the potential for blood damage and thrombus.
David Munjal, vice president of clinical studies, regulatory affairs and quality systems at Terumo Heart, said: “The conditional approval was granted pending answers to some additional questions. Terumo Heart has already responded to the FDA concerning these questions and final approval is anticipated in the near future.”