Highlights:
The pivotal clinical trial enrolled 116 symptomatic patients with severe aortic regurgitation.
Technical success rate was 99.1%, and device success rate at 30 days reached 99.1% - surpas s ing AL I G N -A R ' s b e s t 5 0 0 - c a s e b e n c h m a r k o f 9 6 . 4% d e v i c e success. No conversion to surgery and 100% achieving ideal device performance (no PPM, mean gradients <20mmHg, and absence of moderate/severe regurgitation).
The primary safety composite endpoint rate at 30 days was 14.7%, with only 12.1% (14 cases) requiring new pacemaker implants - a marked improvement over ALIGN-AR's 24% new pacemaker implantation.
All cause mortality at 30 days, 6 month and 12 months were 0.0%, 2.6% and 2.6% respectively. The clinical results successfully met the primary efficacy endpoint, demonstrating superiority over both the pre-specified 30% noninferiority margin and ALIGN-AR's 7.8% all-cause mortality rate.
