Medtronic (NYSE:MDT) said today it won expanded FDA approval for its HeartWare HVAD system, now cleared as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.
The HeartWare HVAD system is a left ventricular assist device designed to aid the heart and increase the amount of blood pumped through the body, the Fridley, Minn.-based company said.
“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,” study co-principal investigator Dr. Joseph Rogers of Duke University said in a prepared release.
The new clearance comes based on results from the company’s Endurance and Endurance Supplemental trials, which evaluated nearly 1,000 destination therapy patients.
“Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system. 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,” Medtronic heart failure biz GM Dr. David Steinhaus said in a press release.
Medtronic said that results from the trials supported that the system was safe and effective for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation, or myocardial recovery, or as destination therapy for patients with no planned subsequent transplantation.
“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,” study co-principal investigator Dr. Francis Pagani of the University of Michigan Health System’s Center for Circulatory Support said in a prepared statement.
In April, Medtronic said that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report lowered stroke rates compared to standard treatment.