Capstan Medical
This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair.
Inclusion Criteria: 1. Age ≥ 18 years at the time of consent. 2. Moderate-to-severe or severe mitral regurgitation. 3. NYHA II or greater symptoms. 4. The participant is considered to be at elevated, but not prohibitive, surgical risk for mitral valve replacement, as determined by the local multi-disciplinary heart team and/or a validated surgical risk assessment tool (e.g., STS PROM). 5. The local multi-disciplinary heart team determines that surgical mitral valve replacement is not the preferred treatment option and that the participant is an appropriate candidate for treatment with the Cap…
Capstan System includes the Capstan Mitral Valve
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