Transcatheter Heart Valve Designed for Severe Aortic Regurgitation

Browns Mills, NJ—Deborah Heart and Lung Center successfully performed its first commercial implant of the Trilogy™ Transcatheter Heart Valve (THV) System (JenaValve) in a patient with severe, symptomatic aortic regurgitation (AR). It is the first commercial implant of the Trilogy system in the tri-state region of New Jersey, Pennsylvania and Delaware.

The Trilogy™ THV System by JenaValve Technology, Inc., received pre-market approval from the FDA in March 2026 and is the only transcatheter aortic valve replacement (TAVR) specifically designed for patients with aortic valve regurgitation. TAVR devices are typically anchored in the calcified tissue of the aorta for stability. In cases of AR, there is no calcification, and this approach does not work.  This new valve is designed to anchor to the aortic valve leaflets.

“Our team can now offer patients with aortic regurgitation a TAVR designed specifically for their condition, said Muhammad Raza, MD, medical director, structural heart program, and division director, interventional cardiology, Deborah Heart and Lung Center.  “Traditional surgery for patients with severe, symptomatic aortic regurgitation is not always feasible. They may not be candidates for invasive procedures, and other transcatheter devices used in minimally invasive procedures do not address the challenges of their underlying anatomy,” said Dr. Raza. “The Trilogy system meets these challenges with locator technology that allows us to securely anchor the system to the aortic valve’s leaflets in the absence of calcium.”

AR is a potentially serious condition that results when the aortic valve’s three leaflets do not close tightly enough, allowing blood to leak backward into the heart’s main pumping chamber. The condition is often under-treated and can be life-limiting, with symptoms that include shortness of breath, fatigue and weakness, chest pains, and swelling of the feet, ankles and legs. Severe cases can result in death.

Of Deborah’s status as an early adopter of this new technology in the tri-state region, Dr. Raza noted, “Deborah leads the way when it comes to finding new ways to help our patients. Heart conditions that were once extremely debilitating can now be treated with minimally invasive procedures that allow our patients to live longer, more productive lives.”

About Deborah Heart and Lung Center

Deborah Heart and Lung Center in Browns Mills, New Jersey, is a teaching hospital in the prevention, diagnosis, research and treatment of heart, lung and vascular diseases. Founded in 1922, Deborah has treated more than 2.3 million hearts from every corner of the United States and 87 countries. From performing the first adult and pediatric open-heart surgeries in New Jersey, to achieving one of the lowest open heart surgery mortality risks in the state as recognized by the New Jersey Department of Health, Deborah is consistently recognized as a leader overall and in patient care from the Centers for Medicare and Medicaid Services (CMS). It is ranked among the top hospitals in New Jersey for patient satisfaction; holds a top-tier Society of Thoracic Surgeons rating which places Deborah among the best cardiac surgery programs in North America; and is rated High Performing by U.S. News & World Report in four specialties: COPD, Heart Arrhythmia, Heart Bypass Surgery, and Heart Failure.

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 (AS) who are at high surgical risk. The Trilogy THV System bears the CE Mark for the treatment of AR and AS and is FDA approved for the treatment of AR. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.  Additional information is available at www.jenavalve.com.