BiVACOR’s Total Artificial Heart Accepted into FDA’s TAP Program

BiVACOR announced that its titanium TAH (Total Artificial Heart) system has been accepted into the U.S. Food and Drug Administration (FDA)’s Total Product Life Cycle (TPLC) advisory program, also known as the TAP program.

The BiVACOR TAH is used as a bridge for transplant in adults with severe, irreversible or univentricular heart failure, particularly those who can’t be treated with traditional left ventricular assist devices (LVADs). It uses a magnetically levitated centrifugal pump inspired by space and industrial technologies, which offers continuous, pulsatile, and physiologically responsive cardiac support.

The FDA’s TAP program was designed to accelerate development and patient access to high-impact medical technologies. The company’s entry offers it proactive, strategic engagement with the FDA throughout the product lifecycle from development to commercialization. TAP participation is reserved for breakthrough-designated devices that could significantly improve outcomes for serious or life-threatening conditions.

As part of the program, BiVACOR will receive more regulatory guidance, earlier identification of scientific and evidentiary gaps, and greater coordination among stakeholders, including payers and patient advocacy groups.

“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.”

The company’s world-first titanium TAH received breakthrough status in June.

“This isn’t just a vote of confidence in BiVACOR, it’s a vote of confidence in the future of heart replacement technology,” said William Cohn, MD, BiVACOR Chief Medical Officer and renowned cardiac surgeon. “The TAP program gives us the opportunity to collaborate with the FDA at a level that aligns with the urgency and magnitude of our mission to bring a durable, fully implantable artificial heart to patients with no other options.”