FDA clears FlexCath Advance Steerable Sheath for Arctic Front Advance Cryoballoon System

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The FlexCath Advance Steerable Sheath is a new enhancement to the Arctic Front Advance Cryoballoon System, which is expected to facilitate easier access to the inferior veins when treating paroxysmal atrial fibrillation.

The US Food and Drug Administration (FDA) has given clearance to Medtronic for its FlexCath Advance Steerable Sheath, a new enhancement to the Arctic Front Advance Cryoballoon System. According to the company, this second-generation sheath has an increased degree of deflection and response, providing greater ease compared to the previous generation in reaching the inferior veins of the heart when delivering and positioning the cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation.

The Arctic Front Advance System is used in minimally invasive procedures to isolate the pulmonary veins using coolant.