Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Inclusion Criteria:

- Symptomatic, severe mitral regurgitation

- NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory).

- The local site heart team determines that the subject has been adequately treated per
applicable standards

- Not a member of a vulnerable population

Exclusion Criteria:

- Left ventricular ejection fraction < 25%

- Left ventricular end diastolic diameter > 7.0 cm

- Prior surgical or interventional treatment of mitral valve involving implantation of
prosthetic material

- Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for
Trial device implantation

- Subjects with non-cardiac comorbidities that are likely to result in a life expectancy
of less than 12 months.