HeartWare International (NSDQ:HTWR) said today that it’s launching a clinical trial aimed at winning CE Mark approval in the European Union for its next-generation MVAD implantable heart pump.
The prospective, non-randomized, single-arm study is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months, HeartWare said.
The 1st patients in the trial were implanted at the Freeman Hospital in Newcastle upon Tyne, England, and the Medical University AKH Vienna, Framingham, Mass.-based HeartWare said.
The company is chasing arch-rival Thoratec (NSDQ:THOR) and its next-gen HeartMate III device. In May Thoratec said it expects to release its device in Europe later this year. Today HeartWare said it asked the FDA for an investigational device exemption for a U.S. MVAD trial; a bid for a 15-patient trial north of the border is under review by Health Canada and expected to begin later this year, the company said.
“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,” president & CEO Doug Godshall said in prepared remarks. “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 trial investigator Dr. Stephan Schueler of Freeman Hospital.
“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,” added investigator Dr. Daniel Zimpfer of the Medical University AKH Vienna. “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.”
