JenaValve shared that it has successfully conducted the initial patient procedure to join a registry dedicated to its Trilogy transcatheter heart valve (THV) system.
JENA-VAD, serving as a forward-looking, multi-center, single-arm clinical registry, is a segment of the ALIGN-AR study. This initiative aims to assess how Trilogy can safely and effectively manage severe symptomatic aortic regurgitation (AR) in patients reliant on a continuous flow left ventricular assist device (cfLVAD). The debut procedure occurred at Cedars-Sinai Medical Center in Los Angeles.
Dr. Raj Makkar from Cedars-Sinai took charge of the first case and acts as an investigator for this registry. He expressed that the registry might provide insights into treatments for a substantial group of LVAD patients afflicted with AR. Furthermore, he noted that findings from ALIGN-AR support further research into whether TAVR with a device specifically designed for this purpose might present a viable remedy for patients with prominent AR.
JenaValve, on the brink of a $1.2 billion acquisition by Edwards, which also includes Endotronix, currently distributes Trilogy for symptomatic AR treatment in Europe under the CE mark, with hopes for FDA clearance by the end of 2025.
“Our objective is to bridge the significant care gap faced by one-third of patients with left ventricular assist devices (LVADs) who experience pronounced aortic regurgitation (AR) and face heightened heart failure risks,” stated John Kilcoyne, CEO of JenaValve. “These patients confront severely limited treatment alternatives, and with the Trilogy system, we aim to explore a potential new path forward.”