JenaValve Announces FDA Approval of Trilogy Transcatheter Heart Valve System

JenaValve Technology, developer and manufacturer of the Trilogy Transcatheter Heart Valve (THV) System, announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the Trilogy THV System for the treatment of patients with symptomatic, severe AR who are at high or greater risk for surgical aortic valve replacement (SAVR). This approval makes the Trilogy THV System the first and only transcatheter device in the United States with a dedicated indication for eligible patients. Symptomatic, severe AR is significantly undertreated and potentially life-altering to the tens of thousands of people annually identified as having this disease in the United States alone.

The PMA approval is supported by successful results from the ALIGN-AR Pivotal Trial, a prospective, multicenter, single-arm Investigational Device Exemption (IDE) study which assessed the safety and efficacy of the Trilogy THV System in high-surgical-risk patients with symptomatic, severe AR.

“With what we have learned about the Trilogy valve from the ALIGN-AR trial, we now have the answer to a question that the cardiology community had struggled with – can we safely and effectively treat patients with severe aortic regurgitation with a transcatheter device? The answer is yes,” said Martin B. Leon, MD, Professor of Medicine and Director of the Centre for Interventional Vascular Therapy at Columbia University Irving Medical Centre/New York-Presbyterian Hospital, and Global Program Chair of the ALIGN-AR Trial. "The unique design of the Trilogy System — with its locator technology providing secure anchoring even in the absence of calcium — addresses the fundamental challenge that has made AR so difficult to treat. This approval establishes a new standard of care for high-risk AR patients and is a landmark achievement for the field of interventional cardiology."

"This FDA approval is the defining moment for JenaValve and, more importantly, those patients in the United States who have suffered from severe aortic regurgitation with nowhere to turn," said John Kilcoyne, Chief Executive Officer of JenaValve. "For too long, high-risk AR patients were left with limited options. Our Trilogy valve changes that reality. Today marks the beginning of a new era in the treatment of aortic regurgitation in America, and we are grateful to the FDA, our investigators, the patients who participated in our clinical program, our investors and the entire JenaValve team whose years of extraordinary commitment made this possible."