HeartWare has completed the Good Laboratory Practice (GLP) animal studies of its HeartWare MVAD Pump to treat Class IIIB / IV patients suffering from advanced heart failure.
HeartWare’s MVAD Pump is a development-stage miniature ventricular assist device and is based on the same proprietary impeller suspension technology used in the HVAD Pump, with its single moving part held in place through a combination of passive-magnetic and hydrodynamic forces.
The MVAD Pump features same as that of the HVAD Pump with a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery.
Northwestern University’s Feinberg School of Medicine associate professor and Northwestern Memorial Hospital Bluhm Cardiovascular Institute Mechanical Assistance and Heart Failure, Heart Transplantation surgical director Edwin McGee said the MVAD was successfully implanted via a left thoracotomy, without cardio-pulmonary bypass, and exhibited blood handling characteristics during the course of the study.
HeartWare International president and CEO Doug Godshall said based on these successful outcomes, we remain on track to commence human clinical studies of the MVAD System, with a newly designed controller, early next year.
"We look forward to explore the potential of the MVAD Pump for both left and right ventricular support, as well as the potential to benefit smaller-sized patients or those with smaller hearts, including pediatric patients." Godshall said.