Terumo Heart has submitted an investigational device exemption to the FDA for approval to begin studying its DuraHeart Left Ventricular Assist System (LVAS) as a destination therapy.
According to Ann Arbor, Mich.-based Terumo, destination therapy gives advanced-stage heart failure (HF) patients who are not eligible for heart transplant long-term mechanical circulatory support.
The DuraHeart LVAS is equipped with a centrifugal flow rotary pump and an active magnetically levitated impeller with three sensors and magnetic coils to optimize blood flow. Terumo said that magnetic levitation helps minimize friction and enables blood to flow in an unconstrained, non-turbulent manner.
The company also said that a DuraHeart pivotal trial evaluating the safety and efficacy of the LVAS in the U.S. seeks to enroll 140 HF patients.
The LVAS system has already received a CE Mark of approval and is soon to be undergoing evaluation during a clinical trial in Japan.