ReValve Solutions Inc.
Prospective, single-arm, multicenter, non-randomized early feasibility study
This study will evaluate the safety and performance of the ReValve System for the treatment of patients with clinically significant symptomatic primary orsecondary mitral regurgitation who are at high, but not prohibitive, surgical risk for mitral valvesurgery and, who are deemed anatomically or technically unsuitable for transcatheter edge-to-edgerepair (TEER) by the multidisciplinary heart team (MDHT).
Key Inclusion Criteria: * Age greater than 18 years * Mitral regurgitation ≥ 3+ documented by echo * Symptomatic New York Heart Association (NYHA) Functional Class II-IVa despite optimal medical therapy for at least 30 days Key Exclusion Criteria: * Severe tricuspid valve pathology with \> moderate tricuspid regurgitation. * Greater than moderate RV dysfunction * Significant aortic valve regurgitation greater than moderate and or stenosis greater than moderate * Prior cardiac surgery or intervention, within 6 months that would prohibit the implant of the Palmetto Valve as determined by the…
ReValve System Mitral Valve Replacement Procedure
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