HeartWare’s MVAD pump has achieved the objectives for system performance, haemocompatibility and biocompatibility in good laboratory practice (GLP) animal studies.
The pump, a development-stage miniature ventricular assist device that is approximately one-third the size of HeartWare’s HVAD Pump, is designed to support the heart’s full cardiac output.
The MVAD is based on the same proprietary impeller suspension technology used in the HVAD, with its single moving part held in place through a combination of passive-magnetic and hydrodynamic forces.
Associate professor Edwin McGee of Northwestern University’s Feinberg School of Medicine in Chicago said that the MVAD was successfully implanted via a left thoracotomy, without cardio-pulmonary bypass, and exhibited excellent blood-handling characteristics during the course of the study.
“At the 90-day explant date, there was no evidence of device wear or thrombus, and end-organ gross and histological results were positive,” McGee said.
HeartWare International president and CEO Doug Godshall said that the company expects to begin human clinical studies of the MVAD in early 2012 with a newly designed controller.
