Device Category Dossier
Valve-non-specific transcatheter heart valve bioprosthesis
Device Category Dossier for Valve-non-specific transcatheter heart valve bioprosthesis. Australian ARTG records, sponsors, device class — compiled by…
- Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent System - Pulmonic Kit - Valve-non-specific transcatheter heart valve bioprosthesis
- Device: Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis
- Device: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
- Device: Valve-non-specific transcatheter heart valve bioprosthesis
- Device: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - Valve-non-specific transcatheter heart valve bioprosthesis
- Device: Edwards SAPIEN 3 Transcatheter Heart Valve System –Valve -non-specific transcatheter heart valve bioprosthesis
Transcatheter heart valve bioprostheses are delivered via catheter-based access approaches including transfemoral, transeptal, and subclavian/axillary routes. These devices are used to relieve stenosis or regurgitation in patients with native or surgically repaired heart valves, including aortic, mitral, and pulmonary valve disease, across varying levels of surgical risk.