The HeartWare system, which includes a HVAD circulatory assist device with a sintered inflow cannula, is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Texas Heart Institute Cullen Cardiovascular Research Laboratories co-director and Center for Cardiac Support chief Bud Frazier said the HVAD pump with an integrated inflow cannula was developed to avoid the attendant infection risks created by a pump pocket.

"A second goal was elimination of mechanical bearings to suspend the impeller, designed to enhance durability and blood handling characteristics," Frazier added.

"Those of us who treat these challenging end-stage heart failure patients are fortunate to have this pericardial, wearless system available for our patients."

The approval was based on the ADVANCE investigational device exemption study, which enrolled140 patients from 30 US hospitals.

The study showed a 94% survival at 6 months and met its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001].

HeartWare International president and chief executive officer Doug Godshall said, "FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients."