Edwards SAPIEN 3 Transcatheter Heart Valve System ?Valve -non-specific transcatheter heart valve bioprosthesis

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Verfügbar ab:

Edwards Lifesciences Pty Ltd

Klasse:

Class III

Hergestellt von:

Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America

Therapiebereich:

66209 - Valve-non-specific transcatheter heart valve bioprosthesis

Anwendungsgebiete:

The Edwards SAPIEN 3 transcatheter heart valve (THV) is comprised of a balloon-expandable, radiopaque, cobalt-chromium alloy frame, a trileaflet bovine pericardial tissue valve, a polyethylene terephthalate (PET) inner skirt, and a PET outer skirt. The Commander Delivery system components are intended for use via transfemoral, subclavian/axillary access routes. The Edwards SAPIEN 3 Transcatheter Heart Valve System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral 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). The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System with Edwards Commander Delivery System is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with ? moderate regurgitation and/or a mean RVOT gradient of ? 35 mmHg

Berechtigungsstatus:

A

Berechtigungsdatum:

2017-01-11