Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
(mm) 20, 23, 26
The Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (THV) system is an Aortic transcatheter heart valve bioprosthesis, with stent-like framework. It consists of the Edwards SAPIEN 3 Ultra transcatheter heart valves and delivery systems. The Edwards SAPIEN 3 Ultra Valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate inner and outer fabric skirts.
Count and link only, sourced from the TGA's Database of Recalls, Product Alerts and Product Corrections. "Market actions" includes recalls, product alerts and product corrections — full detail stays on the TGA's own site.
No recorded changes yet — history accumulates with each release.
Data sourced from Australian Government publications · Not an official government service