Revenue Cycle Insider

Question: Are any medical devices available to treat patients with critical heart failure while they wait for a heart transplant?

Colorado Subscriber

Answer: Equipment like a left ventricular assist device (LVAD) is available to help treat patients with severe heart failure. An LVAD pumps blood from the left ventricle to the rest of the body. The unit is implanted in the chest, while a controller and battery pack remain outside the body.

Another device that comes to mind is BiVACOR’s titanium Total Artificial Heart (TAH). While the TAH has not been approved for commercial use yet, the device recently reached a developmental milestone. On May 30, BiVACOR announced the TAH received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). According to the FDA, the Breakthrough Devices program is for select medical devices and device-led combination products “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

The TAH acts as a bridge to transplant (BTT) for adults experiencing severe biventricular or univentricular heart failure. The TAH is designed to function in situations where treatments currently available, including LVAD, aren’t practical.

“Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that,” said Daniel Timms, PhD, founder and chief technology officer of BiVACOR, in a press release.

The new device from BiVACOR is representative of a new type of artificial heart technology. Magnetic levitation suspends a single, dual-sided rotor, which powers the right and left circulatory systems simultaneously. “[The device’s] simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability,” wrote BiVACOR in its press release.

The company stated that five patients in the U.S. received the device between July and November 2024. After reviewing positive safety and performance data, the FDA then approved the company to expand its trial to 15 more patients starting later in 2025.

Mike Shaughnessy, BA, CPC, Development Editor, AAPC