JenaValve Announces First Case for Inclusion in JENA-VAD Registry

Registry seeks to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in patients with left ventricular assist devices (LVADs) and clinically significant aortic regurgitation

IRVINE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the completion of the first patient procedure for inclusion in the JENA-VAD Registry. The JENA-VAD Registry is a prospective, multicenter, single arm clinical registry nested within the ALIGN-AR study evaluating the ability of the JenaValve Trilogy™ Heart Valve System device to treat severe symptomatic aortic regurgitation (AR) safely and effectively in patients with a continuous flow left ventricular assist device (cfLVAD). The first case was completed at Cedars-Sinai Medical Center in Los Angeles, California.

“Our mission is to address the critical gap for the one third of patients with left ventricular assist devices (LVADs) that develop significant aortic regurgitation (AR) and face significant risk of heart failure,” said John Kilcoyne, CEO of JenaValve. “These patients have very limited treatment options, so with the Trilogy system, we seek to understand whether there can be a new pathway forward.”

“We are excited for the initiation of the JENA-VAD registry and this meaningful step in exploring treatments for the large population of LVAD patients suffering from AR,” said Dr. Raj Makkar, Cedars-Sinai Medical Center, who performed the case and is one of the registry investigators. “The positive results of the ALIGN-AR study provide a strong base and justification for moving forward with this registry studying whether TAVR with a dedicated device may be a solution for these patients with significant AR. We look forward to the results of this registry.”

The JenaValve Trilogy™ Heart Valve System device is used to treat symptomatic severe AR commercially in the EU under CE mark and is being evaluated in the ALIGN-AR IDE study and ALIGN-AR CAP protocol for patients at high-risk for surgery. In these situations, patients with LVAD are excluded because of left ventricular fraction (LVEF) <25% and other exclusions. As such, patients with LVAD have been treated under compassionate use consideration in the United States and off-label in the EU. The registry protocol will ensure consistency in performing the procedure, patient management, and documentation of results in this patient population.

“As a heart failure cardiologist, I focus on very sick patients including heart transplant patients and others that require mechanical circulatory support,” said Dr. Nir Uriel, director of advanced heart failure, cardiac transplantation and mechanical circulatory support at New York-Presbyterian, and chair and national principal investigator of the JENA-VAD Registry. “AR is relatively common in LVAD patients and leads to poor outcomes, and this registry will provide the evidence needed to determine if transcatheter valve replacement can help this group of patients.”

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