September 27, 2017
Medtronic's HeartWare HVAD System Approved for Destination Therapy
September 27, 2017—Medtronic announced that it has received US Food and Drug Administration (FDA) approval for its HeartWare ventricular assist device (HVAD). The HVAD system is a left ventricular assist device (LVAD) intended as destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The system features a small centrifugal-flow pump and is designed to reduce surgical invasiveness, improve patient recovery times, and enhance patient outcomes.
The HVAD system received FDA approval in 2012 as a bridge in patients eligible for heart transplantation. It also received European CE Mark approval that same year for patients at risk of death from refractory end-stage heart failure, and it had previously received CE Mark approval for the bridge to transplantation indication in 2009.
According to Medtronic, FDA approval is based on results from the ENDURANCE and ENDURANCE Supplemental trials, which enrolled approximately 1,000 destination therapy patients. The company stated that the data support the safety and effectiveness of the HeartWare system for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation, for myocardial recovery, or as destination therapy in patients for whom subsequent transplantation is not planned.
The ENDURANCE Supplemental trial was a prospective, randomized, controlled, multicenter evaluation of the incidence of neurologic events in patients receiving the HVAD system as destination therapy who experienced improved blood pressure management. Between October 2013 and August 2015, 465 patients were randomly selected to receive either the HVAD system or, as part of a control group, an alternative LVAD approved by the FDA for destination therapy, in a 2:1 ratio. Patients will be followed long up to 5 years.
In company's announcement, Joseph Rogers, MD, who is a Coprincipal Investigator for the ENDURANCE and ENDURANCE Supplemental trials, commented, "LVADs are an effective and well-established treatment for patients who have progressed to advanced heart failure. In addition to its use as a bridge to heart transplantation, the HVAD system offers a promising option for a growing number of patients who are ineligible for transplant."
Francis D. Pagani, MD, a Coprincipal Investigator for the ENDURANCE and ENDURANCE Supplemental trials, added, "We have been impressed with the overall clinical profile of the HVAD system, as evidenced by the ENDURANCE and ENDURANCE Supplemental trials, which affirmed its safety and effectiveness as a life-saving therapy for patients. The new indication is extremely important for patients with end-stage heart failure as the HVAD system offers significant survival and quality-of-life benefits."