FDA Hands Breakthrough Designation to Ascyrus’ Dissection Stent
The FDA has granted Ascyrus Medical’s Ascyrus Medical Dissection Stent (AMDS) breakthrough device designation for treating acute Type A aortic dissections.
The device is designed as an adjunct to the current standard treatment, which has a high rate of mortality and repeat procedures. The AMDS is designed to reduce the risk of mortality and reoperations by treating malperfusion — the loss of blood supply caused by arterial obstruction — and by inducing positive aortic remodeling.
Results of a clinical trial in Canada and Germany showed a significant reduction in mortality and re-interventions, without any device related adverse events, Ascyrus said.