Device Dossier

Thoraflex Hybrid Plexus - Graft, vascular, synthetic

Device Dossier for Thoraflex Hybrid Plexus - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor Terumo). ARTG record, intended…

Intended purpose

to treat aneurysm and/or dissection of the aortic arch and descending aorta, with or without involvement of the ascending aorta, by open surgical repair in order to reduce the risk of aortic rupture and aortic related mortality.

Functional description

The device is designed for the treatment of aneurysm and/or dissection in the ascending thoracic aorta, aortic arch and descending thoracic aorta. The compacted gelatin sealed device is preloaded in a single use delivery system, placed through the opened aortic arch and deployed leaving the self-expanding stented section positioned inside the descending aorta while the polyester prosthesis repairs/replaces the native aorta. The device has a series of radiopaque markers

TGA Public Summary