Medtronic HeartWare HVAD System Approved For Destination Therapy

 Medtronic FDA approval for its HeartWare HVAD System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.

“LVADs are an effective and well-established treatment for patients who have progressed to advanced heart failure,” says Joseph Rogers, MD, interim chair of the Department of Medicine at Duke University, and a co-principal investigator for the ENDURANCE and ENDURANCE Supplemental trials. “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.”

FDA approval is based on results from the ENDURANCE and ENDURANCE Supplemental trials, which enrolled nearly 1,000 destination therapy patients. The data support the safety and effectiveness of the HeartWare HVAD System for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation (BTT), or myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.

“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,” says Francis D. Pagani, MD, PhD, surgical director of the Adult Heart Transplant Program and director of the Center for Circulatory Support at the University of Michigan Health System, and a co-principal investigator for the ENDURANCE and ENDURANCE Supplemental trials. “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.”

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s needs. It is a progressive condition, affecting more than 6.5 million people in the United States alone,1 a number expected to rise to 8.5 million by 2030.2 A mechanical, centrifugal flow pump, the HVAD System supports heart function and blood flow, continuously drawing oxygen-rich blood from the left ventricle to deliver to the rest of the body.

The HVAD System received FDA approval in 2012 as a bridge to transplant in patients eligible for heart transplants. It also received European CE Mark that same year for patients at risk of death from refractory, end-stage heart failure, and it previously had received CE Mark for the bridge to transplant indication in 2009.

“Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system,” says David Steinhaus, MD, vice president and general manager of the Heart Failure business, which is part of the Cardiac and Vascular Group at Medtronic. “Medtronic strives every day to advance the field of mechanical circulatory support so we can offer physicians more solutions for patients who are living with this debilitating disease.”

The HVAD System features the world’s smallest centrifugal-flow VAD and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. Weighing only 160 grams, the HVAD System’s continuous flow pump is 30 percent thinner and has 38 percent less volume than other centrifugal devices. The pump features a unique integrated inflow cannula that is designed to treat more complex patients while maintaining stable inflow position and eliminating the need for abdominal surgery and device pockets.