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Medical Devices / Submissions and Approvals

FDA Clears Medtronic’s Transcatheter Valve with Advanced Sealing

March 23, 2017
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Medtronic received FDA clearance for its CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery.

The device is designed with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance.

The device is delivered through the EnVeo R delivery catheter system and is indicated for vessels down to 5.5 mm.

The 23mm, 26mm and 29mm sizes of the device are available for use in the U.S. It is not available for use in countries outside of the U.S. — Cynthia Jessup

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