Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System
20, 23, 26 and 29 mm
The Edwards SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve (THV) system consists of the S3UR THV and Delivery System (DS). The THV is comprised of a balloon-expandable, radiopaque, cobaltchromium frame, trileaflet RESILIA bovine pericardial tissue valve, and polyethylene terephthalate (PET) inner and outer fabric skirts. The DS and accessories are intended to facilitate the placement of the bioprosthesis via the transfemoral, transseptal, subclavian/axillary access approaches.
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