
In a report, GlobalData says it expects the FDA to approve the transcatheter aortic valve replacement (TAVR) device by late 2025. TAVR currently serves as an option to treat aortic stenosis (AS). Expanding its indications to include AR could help a previously underserved population, the analysts say.
Such an approval would also widen Edwards’ share in the TAVR market. The company, already a leader with its Sapien valves, agreed to acquire JenaValve as part of a $1.2 billion double M&A swoop alongside Endotronix last July.
“With its potential to improve clinical outcomes for a broader range of patients, the JenaValve Trilogy System underscores the growing adaptability of TAVR technology in treating complex heart conditions,” GlobalData says.
JenaValve already offers Trilogy to treat symptomatic AR commercially in Europe under CE mark. It previously outlined expectations for FDA approval in late 2025 as well.
Meanwhile, data backs the system in treating AR, with a more than 95% procedural success rate in recent trials. ALIGN-AR follow-up data shared in November 2024 confirmed the continued safety and efficacy of Trilogy. It looked at patients with severe, symptomatic AR at high risk for surgery.
After two years, the all-cause mortality rate remained below the study’s predefined performance goal of 25% at one year. Two-year data included excellent hemodynamic outcomes, low rates of paravalvular leak and sustained improvements in quality of life.
“This approval marks the beginning of a new chapter in structural heart therapy – one that has the potential to transform patient outcomes and expand access to treatment for patients who were previously considered untreatable,” GlobalData says.