Health Canada Licenses CardiacAssist’s TandemHeart Circulatory Platform

Health Canada has granted CardiacAssist a Class IV medical device license for its TandemHeart circulatory support system, the Pittsburgh, Pa., devicemaker said Tuesday.

TandemHeart takes over for a damaged heart by withdrawing oxygenated blood from the left atrium and returning it to central arterial circulation. This lets the left ventricle rest and recover, CardiacAssist says.

The device is indicated for 10 days of in-hospital circulatory support in patients with reduced left ventricular function and limited preoperative/preprocedure ejection fraction and patients with high risk of low output syndrome post-procedure.

The system includes a small centrifugal pump that sits on the patient’s leg and can circulate up to 8L/min and a 21Fr transseptal cannula implanted via catheterization or open-heart surgery. The cannula tips have radiopaque disks allowing them to be seen under fluoroscopy, the company says.

An external controller provides on-screen help with setup and support. It can be attached to a hospital bed or IV pole, where it monitors infusion pressure and detect air bubbles.

TandemHeart is also cleared for sale in the U.S. and Europe. — Lena Freund

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