Sam Brusco, Associate Editor10.26.23
JenaValve, maker of the Trilogy transcatheter heart valve (THV) system, released results from its ALIGN-AP pivotal trial for Trilogy in high-risk patients with symptomatic, severe aortic regurgitation (AR) at this year’s Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium.
The investigators concluded Trilogy THV performance was “excellent” with large EOA and low transvalvular gradients as well as low paravalvular regurgitation. The company said echocardiography showed “significant improvement” in LV remodeling, and patients reported sustained improvement in quality of life and heart failure functional status through one year.
“We are incredibly pleased to share the ALIGN-AR results, which demonstrate safety and efficacy as well as exceptional technical performance and reversal of heart enlargement with the Trilogy THV system,” JenaValve’s chief medical officer Dr. Duane Pinto told the press. “We would especially like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact for patients with aortic regurgitation.”
“We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” added Torsten P. Vahl, MD, Principal Investigator of the ALIGN-AR trial. “Pending U.S. regulatory approval, we look forward to being able to offer the Trilogy THV System to our patients with ssAR.”
Results from the study aim to support a premarket approval submission to the U.S. Food and Drug Administration (FDA). If approved, JenaValve says Trilogy THV would become the first, only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for treatment of symptomatic, severe AR.
The investigators concluded Trilogy THV performance was “excellent” with large EOA and low transvalvular gradients as well as low paravalvular regurgitation. The company said echocardiography showed “significant improvement” in LV remodeling, and patients reported sustained improvement in quality of life and heart failure functional status through one year.
“We are incredibly pleased to share the ALIGN-AR results, which demonstrate safety and efficacy as well as exceptional technical performance and reversal of heart enlargement with the Trilogy THV system,” JenaValve’s chief medical officer Dr. Duane Pinto told the press. “We would especially like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact for patients with aortic regurgitation.”
“We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” added Torsten P. Vahl, MD, Principal Investigator of the ALIGN-AR trial. “Pending U.S. regulatory approval, we look forward to being able to offer the Trilogy THV System to our patients with ssAR.”
Results from the study aim to support a premarket approval submission to the U.S. Food and Drug Administration (FDA). If approved, JenaValve says Trilogy THV would become the first, only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for treatment of symptomatic, severe AR.