FDA OKs Expansion of BiVACOR’s Total Artificial Heart Feasibility Study

BiVACOR has successfully completed the first phase of its U.S. Food and Drug Administration (FDA) early feasibility study, with five patients receiving the BiVACOR total artificial heart (TAH) between July and November 2024.

The study evaluated the BiVACOR TAH’s feasibility in supporting adult patients with severe biventricular failure. The study’s initial phase supported patients with the system for up to a month as they waited in the hospital for a donor heart to become available. Five patients were successfully implanted with the TAH, received a heart transplant, and were discharged from the hospital.

This achievement provided the FDA with the data needed to OK the expansion of the early feasibility study to a further fifteen patients.

“We are thrilled to share that the first patients implanted with the BiVACOR TAH achieved expected milestones utilizing the device as a bridge to heart transplant and experienced no complications,” said Daniel Timms, Ph.D., BiVACOR’s founder and chief technology officer. “This has been decades in the making, and to achieve such success during first-in-human trials is extremely encouraging. We are incredibly grateful to all the patients, their families, and clinical partners involved. Without them, we wouldn’t be able to get the TAH to the people that need it most.”

The company said the BiVACOR TAH’s size is suitable for most men and women. Despite the small size, it can offer enough cardiac output for an adult male undergoing exercise.

The product touts a unique pump design with a single moving part—a magnetically suspended, dual-sided rotor with left and right valves positioned within two separate pump chambers. This forms a double-sided, centrifugal impeller that propels blood from the respective pump chambers to the lung and body circulations.

The TAH has no valves or flexing ventricle chambers but pulsatile outflow occurs by transiently increasing the rotor speed each second. The rotor’s non-contact suspension via MAGLEV was designed to remove the possibility of mechanical wear and offer large blood gaps that minimize blood trauma.

“It is incredibly rewarding to see our device provide such efficient support to the first US patients,” said William Cohn, MD, BiVACOR’s chief medical officer and Heart Surgeon at the Texas Heart Institute. “The unique design and features of the BiVACOR TAH translated into an unparalleled safety profile without complications or stroke. Now that the first five patients have been implanted, we will continue to work with the FDA to provide the necessary data to expand our EFS study.”