Reduced Leaflet Motion in Bioprosthetic Aortic Valves — The FDA Perspective  

Oleh:

Laschinger, John C. ; Changfu, Wu ; Ibrahim, Nicole G. ; Shuren, Jeffrey E.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 373 no. 21 (Nov. 2015), page 1996-1998.

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Perpustakaan FK Nomor Panggil: N08.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Bioprosthetic aortic valves play a critical role in improving the health and quality of life of many patients with severe aortic valve disease. On September 16, 2014, St. Jude Medical publicly disclosed that it had temporarily discontinued all implantations of its Portico transcatheter valve worldwide, including those being performed as part of a U.S. investigational device exemption (IDE) study and commercially outside the United States, because of the unexpected finding of reduced leaflet motion in a subgroup of IDE study patients who underwent computed tomographic (CT) scanning approximately 30 days after implantation.

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