A Medical Device Daily

Terumo Heart (Ann Arbor, Michigan) reported receiving conditional FDA approval to begin enrollment in the U.S. pivotal yrial of the DuraHeart LVAS for bridge-to-transplant.

David Munjal, MD, VP of clinical studies of regulatory affairs and quality systems at Terumo Heart, said: “We are extremely pleased that FDA has allowed us to move directly to the Pivotal Trial based on our existing European data. 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.”

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.

Terumo Heart, a division of Terumo (Tokyo), develops technologies focused on treatment of heart failure.