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
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
• Patient age \>21
• The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve reconstruction or replacement
• Symptomatic functional MR≥3+
• NYHA functional capacity ≥2
• LV Ejection Fraction \> 30%, LVEDD \< 68 mm
• The subject meets the anatomical eligibility criteria for available implant size(s)
• The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures.
• The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion
• Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator
⁃ The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits
⁃ Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.