Ascyrus Medical announced today that it has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. This designation underlines the clinical importance of the AMDS and continues the 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.
The FDA’s Breakthrough Devices Programme is intended to accelerate the regulatory review process for certain medical devices and device-led combination products that provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions.
The goal of the programme is to provide patients and healthcare providers with timely access to important breakthrough medical devices by accelerating their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the agency’s mission to protect and promote public health.
An acute type A dissection is a life-threatening condition that requires emergent repair. Today’s 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’s designed to reduce the risk of mortality and reoperations by treating malperfusion and inducing positive aortic remodeling.
Ali Shahriari (West Palm Beach, Florida, USA), CEO of Ascyrus Medical, said: “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.”