Edwards SAPIEN 3 Kit ? Transapical and Transaortic - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Tersedia dari:

Edwards Lifesciences Pty Ltd

Kelas:

Class III

Diproduksi oleh:

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

Area terapi:

60245 - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Indikasi Terapi:

The Edwards SAPIEN 3 transcatheter heart valve (THV) is comprised of a balloon-expandable, radiopaque, cobalt-chromium alloy frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET) inner skirt, and a PET outer skirt. The Certitude Delivery System is designed to facilitate transapical and transaortic access for implantation of the THV. The Edwards SAPIEN 3 valve, Edwards Certitude delivery system, and accessories are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

Status otorisasi:

A

Tanggal Otorisasi:

2019-09-19