Advanced Heart Failure Device Approved by the FDA

The US Food and Drug Administration (FDA) has approved HeartWare HVAD System, an advanced heart failure (HF) therapy for patients not qualified for heart transplants.

The HVAD System, a left ventricular assist device (LVAD), assists patient’s hearts in pumping and increasing blood flow through the body. It is created by Ireland-based medical device company Medtronic PLC.

The FDA approval was based on the results of the ENDURANCE trial, and its supplemental study, which reported safety and efficacy in almost 1,000 patients who met criteria for destination therapy, and were not eligible for transplant.

The device was previously indicated by the FDA as a bridge to cardiac transplantation (BTT), based on the results of a previous study, ADVANCE, in 2012. Combined, the 3 trials' data supported safety and efficacy in BTT, myocardial recovery, and destination therapy patients.

LVADs are a well-established treatment for advanced HF patients, Joseph Rogers, MD, interim chair of the Duke University Department of Medicine, said.

"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,” Rogers, the ENDURANCE co-principal investigator, said.

HF, which affects more that 6.5 million US patients, is a progressive disease expected to raise by another 2 million patients in the country in the next 13 years. The HVAD System provides heart function and blood flow to patients while moving oxygen-rich blood from the left ventricle to the rest of the body. The system first received FDA approval in 2012 as a bridge to heart transplant-eligible patients.

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, said the new FDA indication is “extremely important” for end-stage HF patients, as the device provides survival and quality-of-life benefits.

"Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system," David Steinhaus, MD, vice president and general manager of the Heart Failure business, part of Cardiac and Vascular Group at Medtronic, said. "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."