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s CAUTION – Investigational device. Limited by U.S. Federal law to investigational use under early feasibility study (EFS) and by foreign regulatory agencies for clinical assay in respective countries.
Given the unmet clinical need for patients with moderate or greater functional valve regurgitation (FTR)/ tricuspid insufficiency, NCSI is developing a catheter-guided atrioventricular valved stent for replacement of a failing tricuspid valve. Innovative anchoring mechanisms serve to secure and maintain positioning of the replacement valve.
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