The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said.
Data from the 465-patient supplemental cohort trial will be used to support pre-market approval for the HeartWare HVAD as a destination therapy system intended for long term use, according to the Framingham, Mass.-based company.
The device is currently FDA approved for bridge-to-transplant applications.
“This trial supports our commitment to studying enhanced patient management strategies and identifying best practices for patients who receive the HeartWare system. Optimizing patient care is a critical component of our ongoing focus to improve patient outcomes with mechanically assisted circulation,” co-principal investigator Dr. Joseph Rogers of Duke University said in a press release.
The primary endpoint for the trial is incidence of neurologic injury at 12 months on the originally implanted device and will be tested for non-inferiority against a control device, the company said.
“We are delighted to have completed enrollment in this important study and would like to thank the investigators, coordinators and entire heart team at each hospital site for participating in this trial and for focusing on improved patient management. This 2nd phase of our destination therapy trial reflects HeartWare’s commitment to research and to the betterment of patient outcomes,” CEO Doug Godshall said in a press release.
Last week, the FDA published a security communication warning on issues associated with HeartWare’s HVAD as well as Thoratec’s Heartmate, saying there was an increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s HVAD, as well as bleeding complications associated with both devices.
The warning came a week after HeartWare posted 2nd-quarter results that beat expectations, despite a plunge to red ink, sending its stock price up more than 7%.