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FDA Approves Avalus Surgical Aortic Valve

Medtronic news release; 2017 Aug 2

The FDA has granted US approval and CE Mark for the Avalus surgical aortic valve for the treatment of aortic valve disease. The device is manufactured by Medtronic (Dublin, Ireland).

The Avalus valve is the only stented surgical aortic valve that is MRI-safe and is designed for excellent implantability. The device features several significant developments, including: a supra-annular design for excellent hemodynamic performance, intended to limit central regurgitation; interior-mounted leaflet and frame design to enhance durability; and a low-profile valve design, streamlined valve holder and a single, one-cut release to facilitate ease of implantation.

The FDA approval and CE Mark of the Avalus valve is based on subsets of data from the PERIGON Pivotal Trial, a single arm, non-randomized, prospective study of >1,100 patients from approximately 40 clinical sites across Europe, Canada and the US.

Citation:

Medtronic expands heart valve portfolio with FDA approval and CE Mark of the Avalus™ surgical aortic valve. [news release]. Dublin, Ireland: Medtronic; August 2, 2017: http://phoenix.corporate-ir.net/phoenix.zhtml?c=251324&p=irol-newsArticl.... Accessed August 3, 2017.

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