Ascyrus Medical Dissection Stent Receives CE Mark Approval
February 5, 2019—Ascyrus Medical LLC announced that it has received European CE Mark approval for its Ascyrus Medical dissection stent (AMDS), which is indicated for the treatment of acute type A dissections. The AMDS is an aortic arch remodeling hybrid graft designed as an adjunct to surgical reconstruction. The AMDS is designed to help reduce the risk of complications and reoperations by treating malperfusion and stabilizing or reducing the size of the aorta.
According to the company, CE Mark approval for the AMDS was based on data from the prospectively controlled DARTS I trial, which demonstrated effective single-stage malperfusion treatment, positive remodeling, and improved survival versus standard-of-care historical controls.
Ascyrus presented results from the DARTS I trial at the Society of Thoracic Surgeons 55th annual meeting held January 27–29 in San Diego, California. The data demonstrated that the AMDS effectively treated malperfusion in more than 95% of cases. In addition to recovery of visceral vessels, a unique characteristic in this cohort was healing of malperfusions involving cerebral vessels and reversal of dissection-induced paralysis, noted the company.
The National Principal Investigator for DARTS is Michael Moon, MD, from University of Alberta in Edmonton, Alberta. In the company's announcement, Dr. Moon commented, “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.”