Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study

The study is a multi-center, prospective, single-arm, and non-randomized study designed to
evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction
System

Inclusion Criteria:

- Chronic functional tricuspid regurgitation (moderate or greater)

- Symptomatic despite medical therapy

- The local site Heart Team determines that the patient is appropriate for transcatheter
tricuspid reconstruction

Exclusion Criteria:

- Unsuitable anatomy

- Primary tricuspid valve disease

- Previous tricuspid valve repair or replacement

- Co-morbid condition(s) that, in the opinion of the investigator, could limit the
patient's ability to participate in the study, including compliance with follow-up
requirements, or that could impact the scientific integrity of the study