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…

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.