Why the study?
Calcific aortic stenosis causes progressive restriction of valve opening, and non-implant valve repair using the Leaflex device was developed to score calcified leaflets to increase mobility without valve implantation.
The Leaflex device is a novel non-implant technology designed to score calcium deposits on aortic valve leaflets to reduce the severity of calcific aortic stenosis.
Warrants safety and efficacy trials before any clinical use; leaves open the role of non-implant leaflet scoring in calcific AS.
Introduction Senile calcific aortic stenosis (AS) is a multifactorial degenerative disease which results in calcification of the aortic valve leaflets. A bridging pattern of calcium involving both the centre and bases of the leaflets is typical and causes progressive restriction of valve opening, yielding the clinical syndrome of symptomatic AS. The Leaflex™ device (Pi-Cardia, Rehovot, Israel) is designed to score calcium deposits on the aortic surface of calcified aortic valve leaflets. The scoring lines aim to segment restrictive deposits and thereby increase mobility, reducing the severity of AS without implantation of a bioprosthetic valve. The device has undergone ...
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Baumbach et al. (2021) studied this question.
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