FDA Approves Temporary Heart Pump

The U.S. Food and Drug Administration said it has granted an exemption for the first heart pump that provides temporary support for the heart’s right side.

The Humanitarian Device Exemption, or HDE, was granted to allow use of the pump that’s designed to temporarily support certain critically ill patients.

The FDA said most heart assist devices support the heart’s left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support of their heart’s right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

The federal agency said HDEs facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year.

"This device will provide patients with much needed time until a more permanent treatment option is available," said Dr. Daniel Schultz, 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 Right Ventricular Assist System is manufactured by Levitronix LLC of Waltham, Mass.