Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis - ARTG 471906
Access comprehensive regulatory information for Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 471906 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on December 05, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator)