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FDA clears FlexCath Advance Steerable Sheath
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The FlexCath Advance Steerable Sheath today received FDA clearance and will now be launched in the United States, according to a press release from Medtronic.
The second-generation sheath is intended for use with the Arctic Front Advance Cryoballoon System and is designed to increase the degree of deflection and response. The sheath allows for easy access to the inferior veins of the heart when delivering and positioning the cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation, according to the release. The second-generation sheath has a deflection of 135° vs. the 90° deflection rate of the first-generation product, which may allow the cryoballoon to be better maneuvered and positioned within the heart, according to the release.
The new sheath also includes the following features:
- Radiopaque marker band at 5 mm to provide enhanced visibility under fluoroscopy.
- A deflection mechanism with an ergonomic handle that optimizes the movement of the sheath.
- A hemostasis valve that allows for introduction, withdrawal and exchanging of catheters and guidewires, while preventing air insertion and minimizing blood loss.
The Arctic Front Advance System, which received FDA approval and CE mark approval in August 2012, is used in minimally invasive procedures to isolate the pulmonary veins using coolant.