Ascyrus Medical Announces CE Mark Approval for the Ascyrus Medical Dissection Stent (AMDS)

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Novel aortic arch remodeling device indicated for treatment of acute type A dissections receives CE Mark approval.

With approval, the AMDS offers physicians and patients in Europe the first marketed arch remodeling device and a breakthrough treatment for type A aortic dissections.
Ascyrus Medical, a privately-owned medical device company focused on innovative treatments for aortic dissections, today 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.

Earlier this week at the 55th Annual STS meeting in San Diego, Ascyrus presented results from the DARTS I Trial, demonstrating the AMDS effectively treating malperfusion in over 95% of cases. A unique characteristic in this cohort in addition to recovery of visceral vessels was healing of malperfusions involving cerebral vessels and reversal of dissection-induced paralysis.

“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,” said Ali Shahriari, MD, Founder and CEO of Ascyrus Medical.
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