The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.
Results presented at the International Society of Heart and Lung Transplantation (ISHLT) in San Diego aggregated data from the 140 patients in the clinical trial and an additional 110 patients from Continued Access Protocol (CAP) allotments granted by the FDA in the past year.
As announced in November 2010, the study achieved its primary endpoint of establishing noninferiority 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 president and CEO Doug Godshall said building on the experience from ADVANCE, the largest BTT study conducted to date, the CAP data has added to their understanding of implantation techniques and post-operative care that appear to impact patient outcomes.
HeartWare System received CE marking in the European Union in 2009, and in 2011 the Therapeutic Goods Administration (TGA) granted approval for the device in Australia.
The HeartWare Ventricular Assist System is an investigational device in the US and not yet available commercially in the US.
