Abiomed: FDA approves integrated cannula system for treatment of heart failure

By Lisa Kerner

Charlotte, N.C., July 11 - Abiomed, Inc. said the Food and Drug Administration OK'd its Premarket Approval Application supplement for the company's new integrated cannula system (or minimally invasive cannula) designed to work with its AB5000 and BVS 5000 Circulatory Support Systems for the treatment of acute heart failure.

The new cannula system consists of a 42 French cannula, surgical sewing cuff and an inline connector, according to a company news release.

One benefit of the new cannula is that patients will not require a second sternotomy during off-pump (beating heart) explantations, resulting in shorter hospital stays, less bleeding and less potential for infection.

"This new cannula system offers cardiovascular surgeons a standardized and efficient circulatory support procedure for use with patients in acute heart failure," Abiomed medical adviser Daniel Raess said in the release.

"The device makes for easier off-pump implantations, minimizes damage to the heart muscle and blood, and allows for easier explant of circulatory support once the native function of the patient's heart has returned."

Based in Danvers, Mass., Abiomed develops, manufactures and markets medical products to assist or replace the pumping function of the failing heart.

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