As a condition of approval, Thoratec has agreed to a post-approval study of 247 patients who will be followed until outcome or two years, whichever occurs first. Thoratec will utilize the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to collect the FDA-required data on outcomes, adverse events, functional status and quality of life. Thoratec has also agreed to conduct a second small study at three specific centers to collect data regarding the relationship between bleeding, thrombosis, von Willebrand syndrome and anticoagulation in LVAD (Left Ventricular Assist Device) patients.

"Data from the DT trial demonstrated that the HeartMate II achieved statistically superior results over the patients in the control group who were implanted with the HeartMate XVE. The study primary composite endpoint included survival at two years, free of a debilitating stroke and reoperation to repair or replace the device. The HeartMate II also demonstrated substantially improved two-year survival of 58 percent versus 24 percent for the XVE patients," Burbach noted. "In addition," he continued, "the improvements in patients' quality of life were dramatic at two years of support, with 80 percent of the HeartMate II patients achieving Class I or Class II status, compared to zero at baseline. We believe these outcomes are particularly impressive when you consider the status of these patients at the time they entered the trial. They had a similar profile to those in the REMATCH trial who were managed with the standard of care of optimal medical management and experienced a two-year survival rate of eight percent versus the 58 percent achieved by HeartMate II patients in this trial.


"The data also showed similar outcomes between men and women implanted with the HeartMate II. The smaller size of the HeartMate II enables its use in a broader patient population, including the currently under-served population of small-sized patients with advanced-stage heart failure, most notably women. The trial outcomes also demonstrated superior safety profiles for the HeartMate II, based on its lower level of major adverse events, including reduced rates of infections, renal failure, right heart and respiratory failure and cardiovascular arrhythmia. HeartMate II patients also fared better with respect to shorter hospital stays and lower rates of re-hospitalizations and reoperations per year," Burbach noted.

"This approval will only add to the enthusiasm among the clinical community, based on the HeartMate II's experience with BTT patients, and we look forward to facilitating the adoption of this therapy among a wider group of patients. We believe the HeartMate II represents clinically proven technology, and when combined with our new HeartMate peripherals, offers a compelling and economically viable therapy for heart failure patients. Our focus now is to educate the referring cardiologist community about the efficacy of the device and continue to help VAD centers bring on DT programs. Through our training initiatives, support for centers and educational programs targeted to referring cardiologists, we are committed to advancing the field of mechanical circulatory support and improving the outcomes for a much broader population of advanced-stage heart failure patients," Burbach continued.

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