HeartWare announces initiation of MVAD System CE Mark international clinical trial

HeartWare International, Inc. (Nasdaq: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced commencement of its MVAD^® System CE Mark international clinical trial. The first patients receiving HeartWare's next-generation MVAD Pump were implanted at the Freeman Hospital in Newcastle upon Tyne, England, and at the Medical University AKH Vienna in Austria.

The MVAD Pump is a heart pump that supports a wide range of flows to enable circulatory support for patients with advanced heart failure. The MVAD Pump was designed with a low shear stress impeller and optimal blood flow paths, which together are expected to result in improved hemodynamic performance. In addition, the MVAD System incorporates a pulsatility algorithm called the qPulse™ Cycle that allows physicians to customize the device for each patient, providing four pulse settings designed to enhance aortic valve function and reduce chronic bleeding events.

"With the successful completion of these first implants in Europe, we are taking the next significant step in our efforts to help patients worldwide who suffer from advanced heart failure," said Doug Godshall, President and Chief Executive Officer at HeartWare. "The MVAD Pump is less than half the size of our HVAD^® Pump – currently the smallest commercialized full-support device – and is designed to be implanted through a less-invasive thoracotomy technique. In addition, the MVAD System controller and battery unit, called Peripherals for an Active Lifestyle (Pal™), is expected to greatly enhance the user experience."

"We are encouraged by the initial implant and early post-operative experience with the MVAD System and believe that the benefits of this novel device have the potential to lead to better patient outcomes and an improved quality of life for patients," said Professor Stephan Schueler, M.D., Ph.D., Director of the Ventricular Assist Program at the Freeman Hospital, and an investigator in HeartWare's MVAD System CE Mark clinical trial.

The MVAD Pump, which weighs only 78 grams and displaces 22 cc of volume, has a steerable sewing ring, which enables clinicians to position the inflow cannula to facilitate optimal blood flow into the pump. The integrated Pal controller and battery system includes a touch-screen display and two sizes of small, light-weight, snap-on batteries.

"Since the MVAD Pump requires a comparatively small thoracic space, it will be even more conducive to minimally invasive implant techniques, which is our preferred approach today with the current-generation HVAD Pump," said Professor Daniel Zimpfer, M.D., Director of Mechanical Circulatory Support, Medical University AKH Vienna, and an investigator in HeartWare's MVAD System CE Mark clinical trial. "The MVAD device has the potential to reduce surgical trauma, enable use of fewer blood products during the procedure, decrease adverse events and lower post-implant hospitalization time. Reducing the invasiveness of the surgery will not only enable us to treat a greater proportion of patients with heart failure but may offer a more attractive option to patients at an earlier stage of the disease progression."

The CE Mark trial is a multicenter, prospective, non-randomized, single-arm trial that evaluates the clinical safety and performance of the HeartWare MVAD System for the treatment of advanced heart failure. The trial will enroll 60 patients at 11 sites in the United Kingdom, Austria, Australia, France and Germany (pending final regulatory approval from BfArM). In the trial, patients will be implanted with the MVAD Pump via sternotomy or thoracotomy, and the device will be evaluated for short- and long-term use. The primary endpoint is survival at six months.

HeartWare has submitted to the U.S. Food and Drug Administration (FDA) an Investigational Device Exemption (IDE) seeking approval to commence an MVAD System clinical trial in the United States. Health Canada is also reviewing a submission for a 15-patient, three-center study, which is expected to commence later this year.