Biorefine, a Transcatheter Mitral Annulus Ablation System for the Treatment of Mitral Regurgitation: Pre-Clinical Study in Sheep.

Abstract

Mitral regurgitation (MR) is the most common valvular disease in developed countries. Many patients with functional MR (FMR) are inoperable due to high surgical risk, and effective transcatheter options are limited. Radiofrequency (RF) ablation can contract connective tissue. To assess the feasibility, safety, and efficacy of Biorefine, a novel transcatheter RF ablation system for mitral annulus remodeling without implants, in a preclinical ovine model. Twelve sheep underwent transseptal RF ablation of the posterior mitral annulus under 3D echocardiographic and fluoroscopic guidance. Mitral geometry and coaptation were evaluated acutely (n = 4), at 58 days (n = 4), and 178 days (n = 4). Histology assessed tissue effects. All procedures were complication-free. Eleven of 12 animals showed ≥ 15% annular area reduction (mean 21.8%), ≥ 10% A-P diameter reduction (mean 15%), and 71.9% mean coaptation increase. Histology confirmed localized fibrosis (≤ 3 mm) without off-target injury. Biorefine appears safe, durable, and implant-free for FMR.