AIMS
Transcatheter mitral valve replacement for mitral regurgitation (MR) remains limited due to the need for improved patient screening, device safety and broad applicability for the MR patient population. Tioga Cardiovascular’s novel Luna Mitral Valve Replacement System uses a transseptal procedure to first pull in the native leaflets and chordae before deploying a self-seating valve replacement implant. The two-step procedure targets a wider range of patient etiologies, has a smaller profile to allow future LV remodeling, and aims to safely and effectively improve outcomes for patients with MR.

METHODS AND RESULTS
This First-in-Human experience is a prospective, single-arm, non-randomized, multicenter study conducted in the Republic of Georgia and Paraguay for patients with symptomatic, moderate-severe mitral regurgitation who are deemed non-ideal for surgical intervention or other available treatment options. The primary endpoints in this study are as follows:

• Primary Safety Endpoint: Composite of all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure.
• Primary Performance Endpoint: Number of subjects achieving MVARC technical success – all of the following must be present at exit of catheterization lab:
  • Absence of procedural mortality
  • Successful access, delivery, and retrieval of the device delivery system
  • Successful deployment and correct positioning of the first intended device
  • Freedom from emergency surgery or reintervention related to the device or access procedure

To date, twelve patients have been enrolled in the study, and ten patients were treated per protocol and have completed follow-up through 30 days. This abstract shall present the initial results from this per protocol population treated with the Luna Mitral Valve Replacement System at baseline and 30-days post-operation.  Primary results, including many secondary endpoint analyses and adjudicated events, will be presented. Patient enrollment and data collection are ongoing.

CONCLUSIONS
The present study is the first report of the outcome data for the Luna Mitral Valve Replacement System to treat patients with symptomatic, moderate-severe mitral regurgitation. The system profile and two-step procedure aim to optimize valve placement and improve acute and long-term outcomes. The data presented provide the initial results of this novel device from an FIH experience that would ultimately establish a new foundation for mitral valve replacement therapy.