A Medical Device Daily
The FDA on Thursday approved a Humanitarian Device Exemption (HDE) 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, made by Levitronix (Waltham, Massachusetts), 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.
Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart-assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body.
"This device will provide patients with much-needed time until a more permanent treatment option is available," said Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health. "The approval reaffirms 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.
HDEs facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.S. every year.