CDRH Grants HDE to Right-Side Heart Pump

CDRH has given a Humanitarian Device Exemption to the first heart pump that gives critically ill heart patients support for the right side of their hearts. Most heart pumps assist the left ventricle, which pumps oxygen-rich blood from the heart to the rest of the body.

October 8, 2008

1 Min Read
CDRH Grants HDE to Right-Side Heart Pump

The CentriMag Right Ventricular Assist System, made by Levitronix LLC, assists the right ventricle, which pumps oxygen-depleted blood from the heart to the lungs.The product is approved for use in critically ill heart patients for whom other treatments have failed, and can be used up to 14 days. It is intended to keep patients alive until they can get a heart transplant or a more permanent device implanted. The HDE process is a special program designed for lifesaving devices for rare conditions that will be used on no more than 4000 U.S. patients per year. Sponsors have to demonstrate safety and "probable benefit," as opposed to safety and effectiveness.

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