Ascyrus Medical said today that it won CE Mark approval in the European Union for its Ascyrus Medical Dissection Stent, or AMDS, intended for treating acute type A aortic dissections.
The Boca Raton, Fla.-based company’s AMDS is an arch remodeling hybrid graft designed as an adjunct to surgical reconstruction, and is intended to reduce the risk of complications and reoperations by treating malperfusion and stabilizing or reducing aorta size.
“We continue to be impressed with the clinical outcomes of the AMDS device and are thrilled with this milestone achievement of CE Mark approval. We look forward to partnering with hospitals and physicians throughout Europe to bring this lifesaving technology to more patients world-wide,” founder & CEO Dr. Ali Shahriari said in a press release.
Approval of the AMDS came based on data from the DARTS I trial of the device. Results from the trial indicated effective single-stage malperfusion treatment, positive aortic remodeling and improved survival when compared to the standard of care, Ascyrus Medical said.
“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,” trial national principal investigator Dr. Michael Moon of the University of Alberta Edmonton said in a prepared statement.