Exploring New Solutions for Aortic Regurgitation in LVAD Patients
JenaValve announced the first patient procedure in its JENA-VAD registry, part of the ALIGN-AR study, focusing on the Trilogy transcatheter heart valve (THV) system. This initiative seeks to address the critical treatment gap for left ventricular assist device (LVAD) patients with severe aortic regurgitation (AR), who often face limited therapeutic options.
Key Highlights
- First Procedure: Performed at Cedars-Sinai Medical Center by Dr. Raj Makkar, a leading registry investigator.
- Study Design: JENA-VAD is a prospective, multi-center, single-arm registry assessing Trilogy’s safety and efficacy for AR in LVAD patients.
- ALIGN-AR Foundation: Builds on ALIGN-AR study data to validate transcatheter aortic valve replacement (TAVR) as a viable AR solution for high-risk groups.
Addressing a Critical Treatment Gap
LVAD patients with severe AR are at high risk of complications like heart failure, with few treatment options. JenaValve CEO John Kilcoyne emphasized the importance of this work:
“Our mission is to close the gap for one-third of LVAD patients who develop significant AR. Trilogy represents a new pathway forward.”
The Trilogy System
The Trilogy THV system offers:
- CE Mark Approval: Commercially available in Europe for symptomatic AR.
- Tailored Design: Specifically addresses AR in LVAD patients, setting new standards for care.
- U.S. Expansion: FDA approval anticipated by late 2025, paving the way for broader adoption.
Promising Steps Toward Better Outcomes
The first registry procedure is a critical milestone in improving outcomes for LVAD patients. Dr. Makkar highlighted its significance:
“This registry explores treatments for the large population of LVAD patients with AR, supporting the development of dedicated TAVR devices for this condition.”
Strategic Growth
JenaValve is set to join Edwards Lifesciences in a $1.2 billion acquisition. This underscores the importance of innovative valve technologies in transforming cardiovascular care.
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