Realheart Total Artificial Heart Earns Humanitarian Device Designation

Real Heart AB announced that its Realheart TAH (total artificial heart) has been awarded Humanitarian Use Device (HUD) designation from the U.S. Food and Drug Administration (FDA).

The HUD status means that Ralheart TAH is eligible to apply for Humanitarian Device Exemption (HDE), which is an expedited regulatory pathway that can give the product limited marketing rights.

Realheart TAH is a total artificial heart that mimics the human heart’s structure and physiological function. The HUD status paves the way for the device to treat advanced biventricular heart failure in patients who have few other options and must be supported by a TAH.

HDE will be approved if the company can show data that indicates probable safety and benefit to the intended patient group. The company will continue communicating with the FDA to develop a clinical investigation strategy to support an HDE premarket approval.

“We are extremely pleased that Realheart TAH has been granted Humanitarian Use Device designation by the FDA,” said Ina Laura Perkins, CEO of Realheart. It is gratifying to look forward to our efforts culminating in such humanitarian benefit. We look forward to updating the market on further clinical and regulatory activities and meanwhile continue our preclinical development which will be important for potential future full market approval.”