HeartWare lands approval for a 4th round of pivotal trials for its HVAD ventricular assist device
HeartWare International (NSDQ:HTWR) won the FDA’s okay to add 54 patients to a pivotal U.S. trial of its ventricular assist system as a bridge to transplant for patients with end-stage heart failure.
Under the original protocol, HeartWare enrolled 140 patients at 30 U.S. sites, making the study the largest bridge-to-transplant pivotal trial to date, according to a press release.
HeartWare submitted a pre-market approval application for the HVAD system in December 2010; the device is slated to get the FDA treatment from the watchdog agency’s circulatory devices panel April 25.
The news didn’t garner much love from Wall Street, where HTWR shares were down 1.4% to $68.07 as of about 4:15 p.m. today. Read more