HeartWare completes enrollment in Endurance2 HVAD trial

HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. 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 2n...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Surgical HeartWare International Inc. Source Type: news