August 13, 2019
FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent
August 14, 2019—Ascyrus Medical LLC announced that it has received Breakthrough Device designation from the FDA for its Ascyrus medical dissection stent to treat acute type A aortic dissections.
The company conducted Dissected Aorta Repair Through Stent Implantation (DARTS), a feasibility, safety, and performance trial. DARTS is a large prospective, monitored trial that enrolled patients in Canada and Germany. The results have shown a significant reduction in mortality and reinterventions along with effective malperfusion management, without any device-related adverse events.
According to Ascyrus Medical, the standard surgical treatment for an acute type A dissection is associated with a high rate of mortality and reintervention rates because of malperfusion and continued growth of the aorta. The Ascyrus device is intended to complement the current surgical repair without adding significant time or complexity to the procedure. It is designed to reduce the risk of mortality and reoperations by treating malperfusion and inducing positive aortic remodeling.
The FDA’s Breakthrough Devices Program is intended to accelerate the regulatory review process for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and health care providers with timely access to important breakthrough medical devices by accelerating their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the agency's mission to protect and promote public health.