JenaValve Data Supports TAVR System for Aortic Regurgitation

JenaValve presented results from an expanded cohort of 500 patients in its ALIGN-AR pivotal trial for the Trilogy THV system in high-risk patients with symptomatic, severe aortic regurgitation (AR).

The late-breaking results represent the largest prospective study of transcatheter aortic valve replacement (TAVR) in AR to date. The analysis includes procedural and 30-day outcomes from 500 patients in the ALIGN-AR study and its continued access protocol (CAP)—along with one-year follow-up data on over 300 patients, including 180 from the core ALIGN-AR trial.

In the expanded cohort, the composite 30-day primary safety endpoint was 26.2%, with an upper one-sided 97.5% confidence interval of 30.1%, significantly below the prespecified non-inferiority margin of 40.5%. One-year mortality was 8.1%, well under the study’s performance goal of 25%.

“The robust results from this large, 500-patient cohort provide compelling evidence for the clinical value of the Trilogy valve,” said Dr. Raj Makkar, MD, Cedars-Sinai Medical Center and highest enrolling investigator. “We now have a device success rate of over 95% across 500 patients compared to the success rates of 80 to 85% with available TAVR valves when used in AR patients. This represents a significant advancement in TAVR technology that may fundamentally improve treatment pathways for this patient population.”

“We are incredibly pleased to share these ALIGN-AR results,” said John Kilcoyne, CEO of JenaValve. “These expanded data demonstrate consistent performance of the Trilogy System, potentially offering severe aortic regurgitation patients, who are poor surgical candidates, a path to life-saving treatment. We are eagerly anticipating the approval of Trilogy and the opportunity to bring this innovative solution to patients.”

Last year, JenaValve entered a transaction to be acquired by Edwards Lifesciences.