Irvine, California-based JenaValve can now start the ARTIST trial, slated for early next year. The company — set to be acquired by Edwards as part of a $1.2 billion double M&A swoop alongside Endotronix — also showcased two-year follow-up data from its ALIGN-AR trial of the the Trilogy transcatheter heart valve (THV) system at TCT 2024 last month.
Edwards officials previously said they expect Trilogy — which treats aortic regurgitation (AR) — to win FDA approval in late 2025.
ARTIST will compare outcomes between non-high-risk patients with moderate-to-severe and severe AR treated with Trilogy and those undergoing surgical aortic valve replacement (SAVR). JenaValve says ARTIST aims to provide critical information to clinicians on TAVR compared to regular surgery.
“Our ARTIST RCT reflects our unwavering commitment to advancing research that enhances patient outcomes and offers effective treatment alternatives,” said Dr. Duane Pinto, chief medical officer at JenaValve. “With the commitment of our dedicated investigators, we anticipate a swift enrollment process that brings us closer to transforming existing treatment.”
Meanwhile, the ALIGN-AR follow-up data 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 rate sof paravalvular leak and sustained improvements in quality of life.
