Tag: JenaValve

JenaValve Announces New, Late-Breaking Results from the ALIGN-AR Trial Published in The Lancet and Presented at PCR London Valves

IRVINE, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial for the Trilogy THV System in high-risk patients with symptomatic, severe aortic regurgitation (AR). These results were published in The Lancet and simultaneously presented as part of the Late-Breaking Clinical Trial sessions at PCR London Valves.

JenaValve Announces 1,000th Case with the Trilogy™ Transcatheter Heart Valve (THV) System

IRVINE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the completion of its 1,000th commercial Trilogy procedure, performed in Cologne, Germany, marking a major milestone demonstrating the platform’s growing adoption in treating patients with symptomatic, severe aortic regurgitation (AR) who previously had limited treatment options.

JenaValve‘s Trilogy™ System Featured in Live Procedure at TCT 2025

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.

JenaValve Announced ESC Guidelines Recognize TAVI as Class IIb Recommendation for Aortic Regurgitation

IRVINE, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the newly published guidelines from the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) include transcatheter aortic valve implantation (TAVI) as a treatment option for patients with severe, symptomatic aortic regurgitation (AR) when ineligible for surgery. This decision marks the first formal recommendation for TAVI in AR guidelines.

JenaValve Announces First Patient Enrolled in ARTIST Randomized Controlled Trial (RCT) Evaluating the Trilogy™ System in Aortic Regurgitation (AR)

IRVINE, Calif., July 14, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that patient enrollment has begun in the ARTIST study, an RCT evaluating the safety and effectiveness of the Trilogy System compared to surgical aortic valve replacement (SAVR) in patients with AR. The study is now enrolling patients in both transcatheter and surgical arms with the first case being performed in Los Angeles, California at Cedars-Sinai Medical Center.

JenaValve Announces Late-Breaking Data from the ALIGN-AR Pivotal Trial

IRVINE, Calif. and CHICAGO, March 31, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, presented results from an expanded cohort of 500 patients in the ALIGN-AR Pivotal Trial for the Trilogy THV System in high-risk patients with symptomatic, severe aortic regurgitation (AR).

Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix

July 24, 2024 04:15 PM Eastern Daylight Time IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, […]

egnite, Inc. and JenaValve Announce Novel Research on Outcomes with Untreated Aortic Regurgitation at the 2024 American College of Cardiology Conference

ALISO VIEJO, Calif.–(BUSINESS WIRE)–egnite, Inc., a leading digital health company for cardiovascular care, and JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24). The study, led by esteemed cardiologist […]

JenaValve’s Trilogy THV System Highlighted at CRT 2024

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024. JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.

JenaValve Featured at the PCR London Valves 2023

IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference. The Trilogy THV system was featured in multiple case presentations and scientific sessions throughout […]