CE Mark for Ascyrus Medical Dissection Stent-Ascyrus Medical

Ascyrus Medical, a privately-owned medical device company focused on innovative treatments for aortic dissections, announced the CE mark approval of its Ascyrus Medical Dissection Stent (AMDS) for treatment of acute type A aortic dissections.

The AMDS is an arch remodeling hybrid graft designed as an adjunct to the current surgical reconstruction. The AMDS helps reduce the risk of complications and reoperations by treating malperfusion and stabilizing or reducing the size of the aorta, known as positive aortic remodeling. An acute type A dissection is a life-threatening condition that requires emergent repair. Today�s surgical treatment, although lifesaving, does not effectively treat malperfusion and leaves the aorta untreated beyond the ascending segment, which can lead to negative remodeling, reoperations, and increased risk of mortality.

CE Mark approval for the AMDS was based on data from the DARTS I trial, the largest prospectively controlled device trial for treatment of type A dissections. DARTS successfully demonstrated effective single- stage malperfusion treatment, positive remodeling, and improved survival vs. standard of care historical controls. �By reducing the complications and reinterventions associated with acute aortic dissections, the AMDS significantly improves the care of patients far beyond what we have been able to accomplish prior to the AMDS therapy,� said Dr. Michael Moon, Cardiac Surgeon at the University of Alberta Edmonton and National Principal Investigator for DARTS.