The CE mark trial is a multicenter, prospective, non-randomized and single-arm study that assesses the clinical safety and performance of the HeartWare MVAD System to treat advanced heart failure.
HeartWare has designed miniaturized and hematologically advanced circulatory assist system to support patients with advanced heart failure.
The study will enroll around 60 patients at 11 sites in the UK, Austria, Australia, France and Germany (pending final regulatory approval from BfArM).
HeartWare International president and CEO Doug Godshall 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.
"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."
The system features MVAD Pump that has been implanted to patients 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, which supports a wide range of flows to provide circulatory support for patients with advanced heart failure.
Patients will be implanted with the MVAD Pump through sternotomy or thoracotomy in the trial. Its primary endpoint is survival at six months.
It weighs 78g and displaces 22cc of volume, as well as features steerable sewing ring that allows clinicians to position the inflow cannula to facilitate optimal blood flow into the pump.
Additionally, the MVAD System integrates pulsatility algorithm known as qPulse Cycle, which helps physicians to customize the device for each patient.
Image: HeartWare’s next-generation ventricular assist system. Photo: courtesy of HeartWare Inc.
