FDA approves HeartWare Ventricular Assist System as a bridge to heart transplantation


The US Food and Drug Administration (FDA) has given approval to HeartWare for its HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. 

HeartWare’s pre-market approval was supported with data from the pivotal ADVANCE clinical trial. In the study, 140 patients at 30 hospitals in the USA received the HeartWare investigational device between August 2008 and February 2010. The ADVANCE study achieved a 94% survival at six months and successfully 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]. 

“I have had the opportunity to work on the HVAD project since its conception over a decade ago. The goal was to develop a miniaturised device with an integrated inflow cannula that could be placed within the pericardial sac, avoiding the necessity of creating a pump pocket with its attendant infection risks, as well as simplifying the surgical insertion,” said OH Frazier, chief, Center for Cardiac Support; director, Cardiovascular Surgery Research; and co-director, Cullen Cardiovascular Research Laboratories, at Texas Heart Institute and a global pioneer in mechanical circulatory support. “A second goal was elimination of mechanical bearings to suspend the impeller, designed to enhance durability and blood handling characteristics. Those of us who treat these challenging end-stage heart failure patients are fortunate to have this pericardial, wearless system available for our patients.”

FDA requires a post-approval study as a condition of approval to assess device performance in a real-world setting.  HeartWare’s post approval study is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database. The data for both arms of the study will be entered into the INTERMACS registry by the implanting centres. Other post approval commitments include the transfer of patients from the ADVANCE IDE study into a post approval database as well as an obligation to continue training sites in accordance with an approved training programme. 

In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrolment of a 450-patient destination therapy study at 50 US sites. The final patients were implanted in May 2012, with a two-year, primary endpoint follow-up period. HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA. 

About the HeartWare Ventricular Assist System

The HeartWare Ventricular Assist System features the HVAD pump, a small full-support circulatory assist device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump, with sintered inflow cannula, weighs approximately five ounces and displaces a volume of approximately 50mm.

The HeartWare System received the CE mark in 2009, and the Australian Therapeutic Goods Administration (TGA) approval in 2011. The company states that more than 2,500 advanced heart failure patients globally have received the HVAD pump.