Five patients received the BiVacor TAH between July and November 2024 in the study looking at the TAH as a bridge to donor heart transplant. The initial phase supported patients with the TAH system for up to a month while they waited for a donor heart. These patients had severe biventricular failure.
After the five successful implants and subsequent discharges, the FDA had enough data to greenlight the expansion of the EFS. This allows BiVacor to expand its trial to an additional 15 patients.
“It is incredibly rewarding to see our device provide such efficient support to the first U.S. patients,” said Dr. William Cohn, BiVacor chief medical officer. “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.”
More about the BiVacor TAH
BiVacor designed the TAH to replace the function of the native heart completely. Sized similarly to an adult fist, it uses magnetic levitation technology. Left and right vanes positioned on a common rotor form the only moving part, a magnetically suspended double-sided centrifugal impeller. BiVacor designed it to create pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps to minimize blood trauma and eliminate mechanical wear.
Despite its small size, the TAH can provide enough cardiac output for an adult male undergoing exercise. It has no valves or flexing ventricle chambers, but achieves pulsatile outflow by transiently increasing the rotor speed each second.
The company received FDA investigational device exemption to conduct a first-in-human study for the system in November 2023.
“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, founder and chief technology officer of BiVacor. “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.”
