The U.S. Food and Drug Administration today 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.
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. 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.
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. To receive approval of an HDE application, a company must demonstrate the product's safety and probable benefit. Such products are generally used under the supervision of an Institutional Review Board, a committee that approves, monitors, and reviews biomedical research within a locality.
"This device will provide patients with much needed time until a more permanent treatment option is available," said Daniel Schultz, M.D., 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.
While severe right-side heart failure is uncommon, it can lead to death. It is often caused by left-side heart failure or, in unusual cases, by heart surgery.
Safety data from two multi-center clinical trials showed that the CentriMag system does not expose patients to an unreasonable risk, and the probable health benefit from use of the device outweighs the risk, taking into account the probable risks and benefits of alternative forms of treatment.
Because shortness of breath is common in patients with right-sided heart failure, it is unclear whether the device caused any of the breathing difficulties reported in the study group.
Patients who are unable or unwilling to take anti-clotting medicine should not use the CentriMag system, because bleeding and blood clots are two of the most common adverse events associated with heart assist devices.
The CentriMag Right Ventricular Assist System is manufactured by Levitronix LLC, Waltham, Mass.----
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