An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.
18 years of age or older
Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
Patient must present with an STS Score less than 10%
High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
Severe tricuspid regurgitation
Severe aortic stenosis or insufficiency
Severe mitral annulus calcification
Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
Polares Medical SA
Lead sponsor
Polares Medical, Inc.
Collaborator