Expanded indications could transform aortic regurgitation care.
GlobalData analysts anticipate FDA approval for JenaValve’s Trilogy TAVR system by late 2025, allowing treatment of aortic regurgitation (AR) alongside aortic stenosis (AS). Approval could address a previously underserved, high-risk patient population.
Key Highlights
- Trilogy System: Already CE-marked in Europe for AR, with 95%+ procedural success in trials.
- ALIGN-AR Trial Data:
- Two-year follow-up:
- All-cause mortality under 25%.
- Excellent hemodynamics and low paravalvular leak rates.
- Significant improvements in quality of life sustained over time.
- Two-year follow-up:
Edwards Lifesciences Acquisition
The $1.2 billion acquisition of JenaValve by Edwards Lifesciences positions Trilogy to expand the company’s TAVR market leadership. Analysts expect this approval to redefine treatment options for AR patients at high surgical risk.
“This marks a major milestone in structural heart therapy, unlocking treatment for a previously untreatable population,” GlobalData states.
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