All of the above.
Was approved due to no alternative being considered viable, was under a Special Access Scheme (means we can likely do more), was in Canada, and importantly it’s our first VIV successfully completed with great results.
Who knows the leverage this could have in FDA special access discussions for early use of DurAVR in VIV.
I know some here have been sceptical of this as they considered other valves in the market capable of doing the job so why give DurAVR early access / approval? Well this has called that into question big time.
DYOR and Not advice.
Ann: DurAVR first successful implantation Valve-in-Valve, page-6
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