Effects of device post-dilatation
An assessment of the effects of post-implant dilatation on the leaflets and frame should be conducted if this is an expected use condition to which the (novel) heart valve substitute will be exposed.
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
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