Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital Completes First JenaValve Procedure to Treat Aortic Regurgitation

JenaValve TAVR device (New Brunswick, NJ) - Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital (RWJUH) recently treated their first patient with a next-generation investigational transcatheter aortic valve replacement (TAVR) valve designed to treat severe aortic regurgitation as part of a new clinical trial.

The JenaValve ALIGN-AR Clinical Trial studies percutaneous treatment options for patients with symptomatic, severe aortic regurgitation. With their participation in this clinical trial, Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital now have the capacity to offer a minimally invasive TAVR procedure to patients who meet the inclusion/exclusion criteria.

RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been given a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

One of the key design characteristics of the JenaValve Pericardial TAVR System is its locator technology which enables the device to “clip” onto the native aortic leaflets to secure the valve in place. This unique anchoring mechanism is critical for securing the transcatheter heart valve (THV) to the native aortic valve and allows for anatomical alignment and seating in the absence of calcification that is present in stenotic valves.

JenaValve implantation

Aortic regurgitation, sometimes called aortic insufficiency, is a heart disease that prevents the aortic valve from closing completely. When the valve is unable to close properly, it allows some of the blood to flow backward into the main chamber (left ventricle) each time the heart beats. The leak caused by this condition may prevent the heart from correctly distributing blood to the rest of your body.

“Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital continue to serve as a national leader in treating valve disease. Our focus on less invasive approaches and rapid recovery have helped us maintain outcomes that far exceed national benchmarks in safety, life expectancy, and risks of complications,” said Dr. Leonard Y. Lee, Chair and Professor of Surgery at Rutgers Robert Wood Johnson Medical School, Chief of Cardiovascular Services, Robert Wood Johnson University Hospital New Brunswick.

“By providing a new and effective treatment option for a population of patients that previously had none, JenaValve is a potentially disruptive treatment for aortic regurgitation.” Mark J. Russo, MD, MS, Chief of Cardiac Surgery, Director of Structural Heart Disease and Associate Professor of Surgery, Robert Wood Johnson University Hospital and Rutgers Robert Wood Johnson Medical School. “As one of only fifteen sites in the US able to offer this important therapy, Robert Wood Johnson University Hospital continues to pioneer new treatments in an effort to offer lifesaving therapies for more patients in our communities.”

For more information about the ALIGN-AR Trial, please reach out directly to the Principal Investigator, Mark Russo, MD, or our clinical study team at (732) 235-7800.