AMDS - PTFE Felt Graft
PTFE felt graft component made of a PTFE felt tube is used to buttress and strengthen the aortic tissue in preparation to perform the conventional polyester graft to aorta anastomosis. Uncovered nitinol wire braided stent enables the stabilization of the dissection flap within the aortic arch and descending aorta thereby stabilizing the structure of the aortic wall and promoting healing of the wall. The AMDS device comes pre-mounted on a delivery system. There is no need for X-Ray, fluoroscopy or hybrid room to use the AMDS system.
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Clinical Trial
Intended Use
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 I aortic dissection undergoing open surgical repair within 0 to 14 days after diagnosis.
Primary Objectives
- To demonstrate a clinically meaningful reduction in the number of patients who experience at least one MAE within 30-days post-procedure compared to published outcomes following the standard of care.
- To demonstrate a clinically meaningful increase in the number of patients who have true lumen expansion ≥ 6.0 mm by 1- year compared to published outcomes following the standard of care.
Type of Study:Prospective, non-randomized, non-blinded, single-arm, multicenter interventional study.
Planned Sample Size:93 patients
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