HeartWare VAS Gets Panel Nod Despite Safety, Data Concerns

By a lopsided vote, the FDA’s Circulatory System Devices Panel Wednesday recommended approval of the HeartWare Ventricular Assist System (HVAS), in what could be an early sign of more tolerance by FDA reviewers toward study designs other than traditional double-blind clinical trials. The HVAS — intended as a bridge to heart transplant in end-stage heart failure patients with a one-year mortality rate of 50 percent without treatment — is the first left ventricular assist device that is magnetically levitated and can be implanted entirely within the pericardial space.
Devices & Diagnostics Letter