(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 heart valve designed to treat mitral regurgitation as part of a new clinical trial. It was the first procedure in this trial performed in the New York-New Jersey area.

The ENCIRCLE Clinical Trial studies the Edwards SAPIEN M3 system – an investigational device to replace the mitral valve in patients with severe mitral regurgitation. With their participation in this clinical trial, Rutgers-RWJMS and Robert Wood Johnson University Hospital now have the capacity to offer this minimally-invasive treatment option to patients who meet the inclusion/exclusion criteria.

Mitral regurgitation (MR) is a condition where there is a leak in the mitral valve. It is one of the most common heart valve diseases. A leak in the mitral valve occurs when the leaflets, or flaps, of the mitral valve do not close completely, allowing blood to flow back into the heart as it pumps. The heart has to work harder, as a result, to keep blood flowing and can raise the risk for life-threatening stroke and heart failure. When MR becomes severe, it can profoundly affect a person’s quality of life by causing shortness of breath, extreme fatigue, and other debilitating symptoms. If left untreated, MR can ultimately lead to heart failure and death.

The SAPIEN M3 system is designed to replace the mitral valve through a minimally invasive procedure called transcatheter mitral valve replacement. The system has two parts: the SAPIEN M3 dock, which is designed to encircle the native mitral valve to provide a suitable anchoring location for the SAPIEN M3 valve; and the SAPIEN M3 valve, which is a bioprosthetic valve adapted for use in the mitral position.

“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 and Chief of Surgical Services at RWJUH.

“While transcatheter aortic valve replacement has become commonplace, there is currently no FDA- approved catheter-based replacement device for treating mitral valve disease.  By providing a potentially groundbreaking therapy, the SAPIEN M3 valve may change the paradigm for the treatment of mitral regurgitation,” said Mark J. Russo, MD, MS, Professor of Surgery and Chief of Cardiac Surgery at Rutgers Robert Wood Johnson Medical School and a Cardiac Surgeon at RWJUH and a member of RWJBarnabas Health Medical Group. “As one of only a few sites in the region—and the first in New Jersey—to able to offer this important therapy, Robert Wood Johnson University Hospital continues to pioneer new treatments in an effort to offer life saving therapies for more patients in our communities.”

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

Robert Wood Johnson University Hospital (RWJUH) New Brunswick, an RWJBarnabas Health Facility, is a 600-bed academic medical center that serves as the principal teaching hospital of Rutgers Robert Wood Johnson Medical School and the flagship Cancer Hospital of Rutgers Cancer Institute of New Jersey. Its Centers of Excellence include cardiovascular care from minimally invasive heart surgery to transplantation, cancer care, stroke care, neuroscience, orthopedics, bariatric surgery and women’s and children’s care including The Bristol-Myers Squibb Children’s Hospital at Robert Wood Johnson University Hospital (www.bmsch.org).  A Level 1 Trauma Center and the first designated Pediatric Trauma Center in the state, RWJUH’s New Brunswick campus serves as a national resource in its ground-breaking approaches to emergency preparedness.

RWJUH has been named among the best places to work in health care by Modern Healthcare magazine and received the Equity Care of Award as Top Hospital for Healthcare Diversity and Inclusion from the American Hospital Association. RWJUH Brunswick has earned significant national recognition for clinical quality and patient safety, including the prestigious Magnet® Award for Nursing Excellence and “Most Wired” designation by Hospitals and Health Networks Magazine. The American College of Surgeons’ Commission on Cancer has rated RWJUH New Brunswick among the nation’s best comprehensive cancer centers. For more Information visit us online at www.rwjbh.org/newbrunswick