Expanded Clinical Study of the Tendyne Mitral Valve System
Expanded Clinical Study of the Tendyne Mitral Valve System
The purpose of this study is to generate initial insights into the safety and performance of
 the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral
 regurgitation who are not suitable candidates for conventional mitral valve repair or
 replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up
 evaluations will be conducted through 5 years post implantation.
Inclusion Criteria:

 1. Severe mitral regurgitation of primary or secondary etiology

 2. NYHA functional Class ≥ II. If IV, patient must be ambulatory

 3. Heart team determines patient is not a suitable candidate for traditional surgical
 treatment

 4. Age 18 years or older

 Exclusion Criteria:

 1. Severe mitral calcification or mitral stenosis

 2. Chest condition that prevents transapical access

 3. Prior surgical or interventional treatment of mitral or aortic valves