Terumo Heart Submits IDE for Ventricular Assist System

Terumo Heart has submitted an investigational device exemption (IDE) for its DuraHeart left-ventricular assist system to the FDA as a first step in getting approval for a trial to test the device long-term in patients ineligible for a heart transplant, the company says. Terumo is enrolling patients for the device’s Bridge-to-Transplant trial, it says. DuraHeart already has a CE Mark and is available in Europe.