The FDA approved a Humanitarian Device Exemption (HDE) Tuesday for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart.
The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen, according to the FDA.
“This device will provide patients with much needed time until a more permanent treatment option is available,” said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health. “The approval reaffirms the FDA's commitment to even the smallest patient populations.”
The CentriMag system is for critically ill patients with a failing right ventricle when other therapies have failed. It is intended to be used for up to 14 days to keep the patients alive until their heart recovers or until a heart transplant or long-term heart assist device can be implanted, the agency said.
Levitronix in Waltham, Mass., manufactures the CentriMag system.