The US Food and Drug Administration (FDA) has approved HeartWare International's miniaturised ventricular assist system, designed as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Featuring HVAD, a proprietary circulatory assist pump with a sintered inflow cannula, the HeartWare system is implanted next to the heart, avoiding the need for abdominal surgery.
Texas Heart Institute Cullen Cardiovascular Research Laboratories co-director and Center for Cardiac Support chief Dr OH "Bud" Frazier said the HVAD pump 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 said.
"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 an the investigational device exemption study, which enrolled 140 patients from 30 US hospitals to evaluate the HeartWare system.
The study, named ADVANCE, achieved a 94% survival at six 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], according to the company.
In other clinical development for the HeartWare system, the company has enrolled 450 patients from 50 US sites for a destination therapy study and requested a Continued Access Protocol allocation for destination therapy from the FDA.
HeartWare president and cCEO Doug Godshall said; "Our team is positioned to commence the commercial rollout of the HeartWare system immediately, first facilitating broad use by the 50 US hospitals that participated in our clinical studies, and then with training and expansion to additional US Hospitals."
Image: The HeartWare system featuring a HVAD circulatory assist device with a sintered inflow cannula displaces a volume of approximately 50mm. Photo: Courtesy of PR News Wire.