HeartWare Initiates MVAD Pump Trial

HeartWare International Monday launched a clinical trial evaluating its MVAD system for advanced heart failure.

The multicenter trial will enroll 60 patients across 11 sites in the UK, Austria, Australia, France and Germany. Patients will be implanted via sternotomy or thoracotomy, and the system will be evaluated for both short- and long-term use, with a primary endpoint of survival at six months. 

Results of the trial will be used to support a CE mark submission.

Less than half the size of the company’s HVAD system, the MVAD pump features a low shear stress impeller and optimal blood flow paths to boost hemodynamic performance and enable circulatory support, the Framingham, Mass., devicemaker says.

Trial investigator Daniel Zimpfer says the MVAD device has the potential to reduce surgical trauma, use of blood products, adverse events and post-implant hospitalization time.

HeartWare has filed an application with the FDA seeking permission to launch a U.S. trial. Health Canada is also reviewing a study submission for a clinical trial later in the year. — Jason Scott