HeartWare to commence CE mark trial of the world's smallest blood pump

MVAD pump--Courtesy of HeartWare

HeartWare ($HTWR) announced the initiation of its CE mark trial for the next-generation MVAD blood pump for heart failure patients, touting the investigational device's small size and ease of implantation.

The company already sells the HVAD blood pump as a bridge to transplantation for patients awaiting a donated heart, or as a long-term destination therapy, at least in Europe (but not the U.S., where that indication hasn't been approved yet).

The CE mark trial will consist of 60 patients in 11 sites throughout Europe, and the primary endpoint will be survival at 6 months.

Weighing 78 grams (0.17 pounds), the device is less than half the size of the HVAD, which is already the smallest commercially available pump in the two-company market. Other new features include an algorithm enabling customization of pulse settings, and a new system controller and battery unit.

"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 trial investigator Dr. Daniel Zimpfer, of Medical University AKH Vienna, in a statement. "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."

But the small size comes at a tradeoff, say Leerink equity analysts Danielle Antalffy and Puneet Souda. Describing their interview with an unnamed experienced engineer of the devices, in an analyst note they wrote, "First and foremost, he raised the question of support, a question that's been on the table for some time given MVAD's small size. Based on animal studies published/presented to date, he does think the MVAD is unlikely to deliver full support from a flow perspective given the trend for flow to decline over time and pressure to increase, as a 2013 animal study recently published shows. In his view, however, the lower flow MVAD will be adopted more aggressively in the less-sick patient population that requires lower flow--with patient selection likely critical--while HVAD will remain HTWR's full support device."

HeartWare also announced that it has submitted its Investigational Device Exemption submission to the FDA, which would enable the MVAD to be deployed in U.S. clinical trials. Health Canada is also reviewing a submission for a 15-patient three-center study that would commence later year.

HeartWare is fierce rivals with fellow left ventricular assist device specialist Thoratec ($THOR). The MVAD will compete with Thoratec's investigational Heart Mate III, which was implanted for the time in July during its CE mark trial, also using the less invasive thoracotomy technique.

Leerink previously predicted that Thoratec will gain some marketshare in Europe following the approval of HeartMate III, with FDA approval possible in 2018. They note that HeartMate III is larger than the current HeartWare's current generation HVAD. However the engineer preferred HeartMate III over the MVAD "from a pure engineering perspective."

HeartWare is also awaiting word from the FDA about the fate of its request for an expanded indication of the HVAD to include use as a long-term destination therapy. The Leerink analysts, and the doctors they interviewed, expect the indication to get approved despite a strikingly high stroke rate (around 30%) among destination therapy patients in the device's clinical trial. "Not all strokes are created 'equal'--with most HVAD strokes getting resolved over time and not disabling in nature, thus reducing the overall perceived stroke risk among physicians, in our view," they write.

- read the release

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HeartWare device meets trial endpoint, but stroke data a big concern
Clinical trial finds Thoratec heart failure device better than medical management
Thoratec receives CE mark for new blood pump to assist patients during complex procedures
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