BiVacor announced today that the FDA accepted its Total Artificial Heart (TAH) into its Total Product LifeCycle Advisory Program (TAP).
TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company expects its acceptance into the program to help accelerate its novel titanium TAH system through engagement with the agency through the entire product life cycle. Acceptance comes a few months after the FDA granted breakthrough device designation for the system.
Huntington Beach, California–based 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.
The company received FDA investigational device exemption to conduct a first-in-human study for the system in November 2023. It kicked off a clinical trial last year and the FDA gave the green light for a study expansion in December.
“Acceptance into the TAP program marks a major milestone not just for BiVacor, but for the field of mechanical circulatory support as a whole,” said Daniel Timms, founder and chief technology officer of BiVacor. “The BiVacor TAH has the potential to fundamentally redefine the standard of care for patients with end-stage heart failure. TAP access gives us a powerful framework for working hand-in-hand with the FDA to bring this technology to the patients who need it most.”
