WebThe Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an ... WebEdwards eSheath Introducer Set: For controlled deployment. ... and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable). Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the …
Edwards SAPIEN 3 Ultra Implanter Brochure
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SAPIEN 3 TAVR Durability and Versatility HeartValves
WebGet in touch with us! For more information, submit a physician request form or call our Physician Referral line at 630-527-6363, Monday through Friday from 7 a.m. to 6 p.m. … WebThe device identification (di) numbers for edwards esheath introducer set are (b)(4). The instructions for use (ifu) list hemorrhage requiring transfusion or intervention as a potential risk associated with the overall tavr procedure, including potential access complications associated with standard cardiac catheterization. WebIFUs and Operator Manuals are subject to change; the most current version is available on this site. If you do not find the document you need, have difficulty accessing the … Superseded by Edwards eSheath Introducer Set 2024-02-25. Supersedes … black panther face clipart