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June 30, 2014, Morristown, NJ – Morristown Medical Center became one of the first hospitals in New Jersey and New York to adopt a new minimally invasive system to treat patients with narrowed, failing aortic heart valves who are considered to be at high risk to undergo surgery.
The U.S. Food and Drug Administration (FDA) approved the Medtronic CoreValve® System to treat patients with severe aortic stenosis who are at high risk for surgery based on groundbreaking research showing the transcatheter heart valve had superior survival rates at one year when compared to open-heart surgery, the current gold standard for aortic valve replacement. The CoreValve System also demonstrated low rates of procedural complications, including stroke, one of the most concerning complications of valve replacement because it can affect survival and quality of life.
The Gagnon Cardiovascular Institute at Morristown Medical Center was one of 45 U.S. sites involved in the High Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System.
“The number of patients in our community over the age of 80 and with severe heart disease continues to grow, making it all the more important for us find options that are suitable for these patients and their particular conditions,” explains John Brown, MD, chief of cardiovascular surgery at Gagnon Cardiovascular Institute and principal investigator of the trial at Morristown. “Our participation in this trial signifies our committed effort to provide advanced and comprehensive care to our patients.”
“At Gagnon, we are proud to offer the most advanced therapies to patients who are unable to withstand open heart surgery and offer them an option that means less recovery time, less blood loss, and much quicker recovery,” said Robert Kipperman, MD, Interventional Cardiologist, Gagnon Cardiovascular Institute. “The CoreValve gives patients another chance at life.”
Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.
The CoreValve System replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg or upper chest, and then guided through the arteries into the heart. Once in place, the CoreValve System expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.
The CoreValve System initially was approved by the FDA in January 2014 to treat patients who are too ill or frail to undergo surgery. With this latest approval, Morristown Medical Center now also offers the CoreValve System to patients who are considered at high risk for a surgical heart procedure, serving a broader range of U.S. patients than any other transcatheter aortic valve.
The advanced design of the CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered through the smallest available delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the valve’s self-expanding frame enables physicians to deliver the device in a controlled manner, allowing for accurate placement.
About Morristown Medical Center
Morristown Medical Center, located in Morristown, NJ, is part of Atlantic Health System, one of the largest non-profit health care systems in New Jersey. Accredited by The Joint Commission, the hospital was recognized by U.S. News & World Report as a top hospital nationwide for cardiology, heart surgery, gynecology and geriatrics. Morristown Medical Center also ranked as a “Best Regional Hospital” for cancer, diabetes & endocrinology, neurology and neurosurgery, orthopedics as well as gastroenterology & GI Surgery, nephrology, pulmonology and urology. Morristown Medical Center’s Gagnon Cardiovascular Institute performs more cardiac surgeries than any other hospital in New Jersey, placing its cardiac program in the top two percent in the country. Morristown Medical Center is verified as a Level I Regional Trauma Center by the American College of Surgeons and designated a Level II by the state of New Jersey and was re-designated a Magnet Hospital for Excellence in Nursing Service, the highest level of recognition by American Nurses Credentialing Center for facilities that provide acute care services, a distinction awarded to less than five percent of U.S. hospitals. More information and to find a physician >
About Atlantic Center for Research
The Atlantic Center for Research serves as the central point of contact for all research conducted at Atlantic Health System. This includes new and established clinical trial sponsors and investigators who are affiliated with Atlantic Health System’s medical centers, as well as for attending physicians interested in conducting clinical trials and physicians seeking to refer patients to research studies.
The purpose of the Atlantic Center for Research is to conduct, collaborate and promote the investigation of the scientific basis of medicine. The Atlantic Center for Research works to enhance the health of patients and communities, raise standards of medical care and education, and advance knowledge of the human condition. This includes protecting research participants, ensuring compliance with relevant regulations, providing a sound business structure, and working closely with prospective sponsors to process protocols in a timely and efficient manner. More information on clinical trials and research at Atlantic Health System medical centers >