Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Edwards Lifesciences Pty Ltd

Klass:

Class III

Tillverkad av:

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

Terapiområde:

66209 - Valve-non-specific transcatheter heart valve bioprosthesis

Terapeutiska indikationer:

The Edwards Commander Delivery System consists of a balloon catheter for deployment of the THV, and a Flex Catheter to aid in valve alignment to the balloon, tracking and position of the THV. The delivery system includes a tapered tip to facilitate crossing of the native valve. The handle contains a Flex Wheel to control flexing of the Flex Catheter, and a Balloon Lock and Fine Adjustment Wheel to facilitate valve alignment and positioning of the valve within the native annulus. The Edwards SAPIEN 3 valve and SAPIEN 3 Ultra transcatheter heart valve, Commander Delivery System and accessories are 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).

Bemyndigande status:

A

Tillstånd datum:

2018-08-06