JenaValve has enrolled the first patient in its ARTIST trial, the first randomized controlled study comparing transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients with moderate-to-severe or severe aortic regurgitation (AR).
The landmark trial uses JenaValve’s Trilogy TAVR system, with the initial procedure completed at Cedars-Sinai in Los Angeles. Unlike TAVR’s established use for aortic stenosis, its role in AR remains limited — ARTIST aims to generate pivotal evidence for broader use in lower-risk AR patients.
Analysts anticipate FDA approval for the Trilogy valve in AR by late 2025, expanding options for this underserved patient group. JenaValve was acquired by Edwards Lifesciences in 2024 as part of a $1.2 billion deal to boost Edwards’ TAVR leadership.
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