Medtronic bags expanded FDA OK for heart failure pump

The FDA approved Medtronic’s HeartWare implantable heart failure pump as a destination therapy for heart failure patients who are not candidates for a heart transplant.

The Heartware ventricular assist device (HVAD) is a small and powerful pump for the treatment of congestive heart failure, in which a patient’s heart does not pump enough blood to support the body. It is the first pump designed for implantation in the pericardial space and so doesn’t need a pump pocket.

The new nod supplements a previous approval for the HVAD to be used as a bridge to heart transplant. Medtronic acquired HeartWare for $1.1 billion in June last year.

"[Left ventricular assist devices] are an effective and well-established treatment for patients who have progressed to advanced heart failure," said Joseph Rogers, M.D., of Duke University, a co-principal investigator for the clinical trials on which the approval was based. "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."

The new approval is based on data from the Endurance and Endurance Supplemental trials, which enrolled nearly 1,000 patients who would receive the pump as an alternative to a heart transplant. The data showed the device was safe and effective for patients for whom a transplant was not planned, as well as an interim solution for patients awaiting transplant.

"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," said Francis D. Pagani, M.D., Ph.D., surgical director of the Adult Heart Transplant Program and director of the Center for Circulatory Support at the University of Michigan Health System, the other co-principal investigator of the trials.

Besides designing machines to take over organ function, companies are working to address the mismatch in the supply and demand for donor organs. With its organ care systems, TransMedics focuses on preserving organ function so fewer donor organs go to waste. And eGenesis is using the gene-editing tool CRISPR to cut a harmful virus out of the pig genome, which could lead to the possibility of transplanting animal organs into humans.