Achieving long-standing goals"I've had the opportunity to work on the HVAD
® project since its conception over a decade ago. The goal was to develop a miniaturized 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," stated O.H. "Bud" Frazier, MD; 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."
Commencing Commercialization"Our team is positioned to commence the commercial rollout of the HeartWare System immediately, first facilitating broad use by the 50 U.S. hospitals that participated in our clinical studies, and then with training and expansion to additional U.S. hospitals," added Mr. Godshall. "As always, HeartWare remains committed to enhancing outcomes for patients with end-stage heart failure and we will continue working to improve the overall clinical experience with the HVAD."
HeartWare's pre-market approval (PMA) submission included data from the Company's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HeartWare System as a bridge to heart transplantation for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010. The ADVANCE study achieved a 94% survival at 6 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]. Four supplemental allotments of patients have been granted by the FDA under a Continued Access Protocol (CAP), encompassing more than 250 additional patients.
To help assure the continued safety and effectiveness of an approved device, FDA requires a post-approval study (PAS) as a condition of approval under 21 CFR 814.82(a)(2) to assess device performance in a real-world setting. HeartWare's PAS 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 centers. 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 program.