This article is more than 5 years old. Information may no longer be current.
LVAD system approved as destination therapy
Click Here to Manage Email Alerts
Medtronic announced that its left ventricular assist device has been approved by the FDA as a destination therapy for use in patients who cannot have heart transplants.
The system (HeartWare HVAD) includes the world’s smallest centrifugal-flow VAD and was initially approved in 2012 as a bridge to transplant in patients eligible for transplantation, according to a press release issued by the company.
Approval for the new indication was based on results of the ENDURANCE and ENDURANCE Supplemental trials, in which the device was found to be safe and effective in patients with advanced, refractory left HF; data now support the safety and effectiveness of the device, regardless of whether patients required it as a bridge to transplant, as a destination therapy or for myocardial recovery, the company stated in the release.
“There had been only one device approved in the United States for mechanical circulatory support in non-transplant candidates,” Joseph G. Rogers, MD, interim chair of the department of medicine at Duke University and a co-principal investigator of ENDURANCE and ENDURANCE Supplemental, told Cardiology Today. “Having another alternative for our patients is a very important next step in the evolution of the therapy.”
Mortality rates for patients with LVADs have remained stable in recent years, so “the next step is to conduct trials to help us understand better ways to take care of patients with LVADs until the next large innovation comes,” he said. – by Erik Swain
Disclosure: Rogers reports no relevant financial disclosures.
Editor’s Note: This article was updated on Sept. 28, 2017 to clarify the patient population of the ENDURANCE and ENDURANCE Supplemental trials. The Editors regret the error.