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Medical Devices / Submissions and Approvals

FDA Hands Breakthrough Designation to Ascyrus’ Dissection Stent

Aug. 16, 2019

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.

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