FDA Approves JenaValve’s Trilogy Transcatheter Heart Valve System

JenaValve has received U.S. Food and Drug Administration (FDA) premarket approval for its Trilogy THV system to treat patients with symptomatic, severe aortic regurgitation (AR) at high or greater risk for surgical aortic valve replacement (SAVR).

According to the company, this approval makes Trilogy THV the first and only transcatheter device in the U.S. with a dedicated indication for eligible patients.

The PMA approval was supported by results from the ALIGN-AR pivotal trial. The prospective, single-arm, investigational device exemption (IDE) study evaluated the safety and efficacy of Trilogy THV 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 Center for Interventional Vascular Therapy at Columbia University Irving Medical Center/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.”

In November, JenaValve announced the completion of the 1,000th commercial Trilogy THV procedure, performed in Cologne, Germany. University Hospital Cologne’s Dr. Matti Adam was one of the surgeons performing the 1000^th case.

“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, CEO 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.”

In January, the U.S. District Court for the District of Columbia granted the motion from the U.S. Federal Trade Commission (FTC) for an injunction to block Edwards’ proposed acquisition of JenaValve.