The study will evaluate the safety and feasibility of the DurAVRTM THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
This first study is only small because they need to go through the process to ensure it’s safe and basically confirm what we all know it will do with the data to date.
Going by Edwards and Medtronic the pivotal trial is the one that has decent numbers.
But we will be hopeful of getting Breakthrough Device Designation off the back of Valve in Valve one would think.
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
3D printed heart valves, page-21
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