FDA accepts CryoLife®‘s IDE application for clinical trials.
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
