HeartWare International Inc. (NSDQ:HTWR) won approval from the Food & Drug Administration to begin enrolling patients in a clinical trial of its cardiac assist device as a so-called “destination therapy.”
The FDA granted the Framingham, Mass.-based firm an investigational device exemption for the 450-patient Endurance study, which will examine the suitability of HeartWare’s ventricular assist system as a final therapy for patients with end-stage heart failure who can’t have a heart transplant and haven’t responded to other therapies.