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Breakthrough Dissection- Specific Remodeling Device for Treatment of Type A Dissections Receives Health Canada Approval

Ascyrus Medical today announced that Health Canada has approved it’s Ascyrus Medical Dissection Stent (AMDS) for treatment of acute type A aortic dissections.

BOCA RATON, FLORIDA, UNITED STATES, December 4, 2018 / -- Ascyrus Medical, a privately-owned medical device company focused on innovative treatments for aortic dissections, today announced that Health Canada has approved it’s Ascyrus Medical Dissection Stent (AMDS) for the treatment of acute type A aortic dissections. The AMDS is the first marketed arch remodeling hybrid graft. Composed of a superhelical nitinol stent attached to a PTFE cuff, it is designed to complement the current surgical standard of care.

An acute type A aortic dissection is a life-threatening condition that requires emergent repair. Today’s surgical treatment, although lifesaving, is not an effective modality for treatment of malperfusions and leaves the aorta untreated beyond the ascending section, which can lead to unfavorable remodeling, reoperations, and increased risk of mortality. “Our vision was to design a more effective treatment option for these patients, one that allows one-stage management of malperfusions and reverses the process of negative remodeling without adding extra time or complexity in this critical and emergent setting” said Dr. Ali Shahriari, Founder and CEO of Ascyrus Medical.

Ascyrus recently presented the DARTS clinical trial results at the annual EACTS meeting in Milan, and also has published results in the Journal of Thoracic and Cardiovascular Surgery. The DARTS Trial showed that the AMDS is a safe and reproducible adjunct to current surgical treatments of acute type a dissection repair without prolonging the procedure or adding any additional risks to the care of these critically ill patients. The AMDS promotes early positive remodeling in the aortic arch and also serves as an effective treatment for dynamic malperfusion involving major aortic branches.

“It’s been a true pleasure to participate in the DARTS trial and witness the improvements in this very sick subset of our patients. We look forward to helping to train more centers and surgeons throughout Canada on this ground-breaking technology” said Dr. Michael Moon, Cardiac Surgeon at the University of Alberta Edmonton and National Principal Investigator for DARTS.

“We’re thrilled with this milestone achievement from Health Canada and look forward to partnering with sites and surgeons throughout Canada to help bring this life-saving technology to more patients. The AMDS represents a significant leap forward in the treatment of aortic dissections” Shahriari said.

Ali Shahriari
Ascyrus Medical
+1 617-839-8525
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