Ascyrus Medical Dissection Stent - Aortic arch endovascular stent-graft

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Cryolife Medical (Australia) Company Pty Ltd

Klass:

Class III

Tillverkad av:

Ascyrus Medical GmbH Bethmannstrasse 8, Frankfurt, 60311 Germany

Terapiområde:

62573 - Aortic arch endovascular stent-graft

Terapeutiska indikationer:

The AMDS is constructed of an uncovered Nitinol wire braided stent attached proximally to a PTFE felt graft component. The distal uncovered stent component enables the stabilization of the dissection flap within the aortic arch and descending aorta stabilizing the structure of the aortic wall and promoting healing. The proximal PTFE felt component is used to buttress and strengthen the aortic tissue in preparation to perform the conventional polyester graft to aorta anastomosis. The AMDS is intended for aortic repair, aortic remodeling and re-expansion of the intimal flap within the ascending aorta, aortic arch, and into the descending aorta for patients with acute DeBakey Type I aortic dissections undergoing open surgical repair within 0-14 days of diagnosis.

Bemyndigande status:

A

Tillstånd datum:

2023-05-24