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Medical Devices / Submissions and Approvals

FDA Hands Breakthrough Designation to Ascyrus’ Dissection Stent

Aug. 16, 2019
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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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