Abiomed Inc. has received FDA approval, under special humanitarian device exemption, for system upgrades to its AbioCor implantable artificial heart. The device replaces severely damaged hearts for patients who are not eligible for a transplant or alternative treatment. The approval restricts the device from being sold to more than 4,000 patients in the U.S. per year. The company expects to charge $250,000 per AbioCor unit.

The FDA Humanitarian Device Exemption (HDE) is an application that is similar to the FDA premarket approval (PMA) application. An HDE is granted for an HUD (Humanitarian Use Device), which, according to the FDA, is a:

“Medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.”