IRVINE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the 2025 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA with a live case broadcast from the ARTIST study as well as late-breaking data from PREVUE-VALVE.
The live broadcast featured a procedure as part of the ARTIST study, a randomized controlled trial (RCT) evaluating the safety and effectiveness of the Trilogy System when implanted in intermediate and low risk severe symptomatic Aortic Regurgitation (AR) patients compared to surgical aortic valve replacement (SAVR) in patients. The session titled “Transcatheter Aortic Valve Replacement for Aortic Regurgitation” featured a live broadcast from the Cedars-Sinai Medical Center, Los Angeles, CA showing a Trilogy implant in an AR patient, implanted by Dr. Raj Makkar, MD.
“We are very appreciative of the entire expert team at Cedars Sinai. They beautifully demonstrated use of TAVR for this patient enrolled in the ARTIST study. We are only at the beginning of a long journey evaluating lower risk patients in this trial and we are thrilled with our investigators' engagement,” said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
ARTIST is designed to provide critical evidence for the treatment of moderate-to-severe and severe AR in patients that are not at high risk for surgical aortic valve replacement and is the first-ever randomized study comparing SAVR vs. transcatheter aortic valve replacement (TAVR) in AR patients. The study will help expand the use and visibility of the Trilogy System, beyond those at high surgical risk.
“The excitement at TCT for not just our Trilogy THV system, but for better treatment options and outcomes in AR was unmistakable,” said John Kilcoyne, Chief Executive Officer of JenaValve. “The growing body of clinical evidence, awareness in the physician community and real-world outcomes leave me confident that a new day is on the horizon for those suffering from AR in the U.S. Thank you to the clinical staff and all involved with the broadcast helping advance the ARTIST study.”
“Having the opportunity to share the work we are doing with the broader structural heart community is immensely meaningful to me, our team and the many patients suffering from AR,” said Dr. Raj Makkar, MD, Cedars-Sinai Medical Center. “These patients have faced insufficient treatment options for too long. The cases and studies showcased at TCT help grow awareness and lay the groundwork toward expanding therapies and improving outcomes for this underserved patient population.”
Additionally, late breaking data presented from the PREVUE-VALVE study also helps us better understand the prevalence of Valvular Heart Disease (VHD) in Americans.
“Valvular heart disease remains underdiagnosed, with many unaware of their condition. Prevalence increases sharply with age, highlighting the need for greater awareness and more effective treatment strategies. AR in particular, is significantly underestimated due to the challenges and complexity of accurate assessment,” said David J Cohen, MD, principal investigator of the PREVUE-VALVE study and Director of Clinical and Outcomes Research at the Cardiovascular Research Foundation. “As the population continues to age, less invasive treatment options like the Trilogy valve are essential to improving care for this growing and vulnerable patient group.”
About JenaValve
JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company's Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. In the US, the Trilogy THV System is limited to investigation use only.
JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.
JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.
US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
Additional information is available at www.jenavalve.com.
JenaValve Contact:
Daniel Sun
dsun@jenavalve.com
