Nyra Medical, Inc.
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral regurgitation.
Key Inclusion Criteria: * Age \> 21 years at time of enrollment * Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits * Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation * Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team * Patient is suitable for transcatheter mitral valve repair as determine…
CARLEN System
Arctuva estimate
Verify or correct the compensation shown for this listing.