Establishing TAVR for the Treatment of Aortic Regurgitation(1)

Tuesday, 15. June 2021 13:05

IRVINE, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer, and manufacturer of a novel transcatheter aortic valve replacement (TAVR) system, is pleased to announce today the 100th global implant of the Trilogy™ Heart Valve System. This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).

AR is a condition that occurs when a patient’s aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle. The current treatment for high surgical risk patients who are not candidates for open-heart surgery is limited and consists of medical management.

"The enrollment of the 100th patient in the ALIGN-AR trial is a significant milestone towards the ultimate goal of making Trilogy TAVR System available to high surgical risk AR patients,” said Martin Leon, MD, Global Program Chair for the ALIGN-AR Trial. “The sites participating in the ALIGN-AR study across the U.S. and Europe are committed to the clinical program required to provide safety and effectiveness evidence for these high-risk patients with AR.”

The JenaValve Trilogy System consists of a Transcatheter Heart Valve and Transfemoral Delivery System. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial tissue valve manufactured using state-of-the-art tissue processing techniques. The transfemoral catheter is designed to deliver the bioprosthesis using a simple stepped approach to achieve anatomical positioning within the native valve. The system is available in three sizes, enabling the treatment of a broad range of annular diameters.

“With the Trilogy Valve, I will have a TAVR option that is uniquely designed for the challenging anatomical characteristics of AR patients. As the ALIGN-AR Trial Co-Principal investigator, I am excited to lead and participate in the Trial to make this device available to high-risk AR patients”, said Torsten Vahl, MD.

“I am pleased to be part of the ALIGN-AR Trial as the hemodynamic effects of severe AR in high-risk patients are debilitating, and the current ALIGN-AR Trial and Trilogy Heart Valve System provides us with a minimal invasive transfemoral medical procedure that has the potential to change the treatment paradigm for what I believe to be a vastly underdiagnosed and undertreated AR patient population," said Raj Makkar, MD.

In addition to the enrollment of the 100th patient into the ALIGN-AR Trial, in May of this year, the Trilogy Heart Valve System became the first transfemoral device of its kind to receive CE Mark for treating symptomatic patients with severe aortic regurgitation and severe aortic stenosis1 who are at high surgical risk.

“We are enthusiastic the ALIGN-AR Trial has reached this milestone, providing a potential path forward to bringing a TAVR treatment for symptomatic, severe AR patients at high risk for surgery. It is impressive to observe the engagement of our global clinical sites,” said Vinny Podichetty, Vice President of Clinical Affairs at JenaValve. “We look forward to building on this momentum to achieve the ultimate goal of PMA approval, which will make this new therapy indication a reality.”

About JenaValve

JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVR) systems to treat patients suffering from aortic valve disease.

JenaValve is backed by Bain Capital Life Sciences and Cormorant Asset Management and European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, and VI Partners.

Additional information is available at www.jenavalve.com.

Contact:
Investor Relations
Matt Bacso, CFA
matt.bacso@gilmartinir.com

Affiliations:
Martin B. Leon, MD, Professor of Cardiology and Director, Center for Interventional Vascular Therapy at the Columbia University Irving Medical Center, NY Presbyterian Hospital
Torsten P. Vahl, MD, Assistant Professor of Medicine, Center for Interventional Vascular Therapy at the Columbia University Irving Medical Center, NY Presbyterian Hospital
Raj Makkar, MD Associate Director, Interventional Technologies, Smidt Heart Institute at Cedars-Sinai Hospital

US: Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.

  1. The JenaValve Trilogy Heart Valve System is indicated for symptomatic, severe, high-surgical risk patients.


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