Tuesday, October 7, 2008

Levitronix heart pump gets FDA Humanitarian Device Exemption

By Mass High Tech Staff

A heart pump that supports the right ventricle of the heart, and developed by Waltham-based Levitronix LLC, has received a Humanitarian Device Exemption (HDE) by the U.S. Food and Drug Administration. The CentriMag Right Ventricular Assist System provides temporary support in helping the heart pump oxygen-depleted blood into the lungs to fill up on oxygen — a function normally conducted by the right ventricle and not usually requiring as much assistance as left ventricle failure, which can affect the moving of oxygen-filled blood throughout the body.

Designations of HDE are meant to apply new treatments or diagnosis technology to conditions impacting fewer than 4,000 people annually in the U.S. In order to achieve HDE status, companies must show the benefits and safety features of the product and enable supervision from an Institutional Review Board.

Right-sided heart failure, which often is caused by an initial left-side heart failure, or possibly by heart surgery, tends to be characterized by shortness of breath and could ultimately lead to death.

The heart pump can be used temporarily for up to 14 days to keep a person’s heart functioning either until recovery or until a heart transplant. The device requires the use of anti-clotting medicine, since heart assist devices can potentially lead to bleeding and blood clots.