AMDS delivery system

Ascyrus Medical has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. A press release reports that this designation serves as validation of the clinical importance of the AMDS and represents a significant milestone in the continued advancement of the technology globally. Ascyrus Medical conducted the largest prospective, monitored type A dissection trial (DARTS) with patients enrolled in Canada and Germany. The results have shown a significant reduction in mortality and re-interventions along with effective malperfusion management, without any device related adverse events.

At present, according to the press release, standard surgical treatment is associated with a high rate of mortality and reintervention rates due to malperfusion and continued growth of the aorta. The AMDS complements the current surgical repair without adding significant time or complexity to the procedure. It is designed to reduce the risk of mortality and reoperations by treating malperfusion and inducing positive aortic remodelling.

Ali Shahriari, CEO of Ascyrus Medical, says: “Receiving Breakthrough Device Designation will accelerate our efforts and partnership with the FDA to secure a US approval for the AMDS. This is aligned with our commitment to offer life-saving and innovative products, supported by rigorous clinical data, to make a difference in patient’s lives. We look forward to close collaboration with the FDA and our clinician partners to continue to advance the treatment options for patients suffering from this deadly disease.”