Professor Wolfgang Rottbauer from Ulm University Heart Center presented 3-year results from the HighLife TSMVR Feasibility Study (n=35) at TCT 2025, demonstrating a techcnical success rate of 88.6% with no procedure-related mortality, MI, or stroke. Valve performance showed no thrombosis, obstruction, or hemolysis, with only 2 cases of non-intervened PVL (>1+). All patients maintained MR≤1+, confirming HighLife TSMVR as a safe and effective long-term solution for high-surgical-risk patients with significant mitral regurgitation.

Wolfgang Rottbauer's single-center experience compared pre- and postoperative TTE/TEE echocardiograms from 25 patients, revealing significant annular reduction in all cases. Thomas E. Waggoner further supported these findings by presenting left ventricular reverse remodeling outcomes from another HighLife TSMVR single-center study. 

Mirjam Kessler's comparative analysis of 19 HighLife cases versus 400 patients from the CHOICE-MI Registry demonstrated comparable procedural performance, 30-day safety profiles, and 1-year outcomes, with both cohorts achieving excellent regurgitation elimination. 

HighLife has now submitted its CE registration application, signaling the imminent global commercialization of the HighLife TSMVR system.