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Initial clinical results for SIKELIA™ polymeric heart valve (THV) for TAVI in severe symptomatic aortic stenosis showed favorable 1-year safety and performance: reduced mean pressure gradient, increased effective orifice area, improved NYHA class, 6-minute walk test, KCCQ score, and normal leaflet mobility without HALT or calcification in 12 patients (max 27 months follow-up).[2][3]
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