The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction: Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint

The ability to deploy the annuloplasty ring in a percutaneous fashion affords an improved safety profile for surgical candidates, as well as surgical style solution for those patients that are at elevated risk for surgery due to comorbidities and advanced age. This early feasibility study allows treatment of higher risk surgical candidates with a surgical- level annuloplasty repair therapy by the AMEND™ Implant.