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www.fdanews.com/articles/182961-medtronic-gets-ce-mark-fda-approval-for-aortic-surgical-valve

Medtronic Gets CE Mark, FDA Approval for Aortic Surgical Valve

August 7, 2017

Medtronic announced CE Mark and FDA approval for its new aortic surgical valve.

The Avalus aortic surgical valve is indicated for treatment of aortic valve disease. The device is the only MRI-safe stented surgical aortic valve on the market, according to the company.

The valve features a design built around limiting central regurgitation, a single, one-cut release and a more durable frame design.

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