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January 24, 2014, Morristown, NJ – Gagnon Cardiovascular Institute at Morristown Medical Center today became the first hospital in the tri-state area to adopt a new minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. These patients have a 50 percent risk of death at one year unless they are treated.
The U.S. Food and Drug Administration (FDA) recently approved the CoreValve System due to its positive clinical performance in a U.S. clinical study. It had low rates of common complications – such as stroke and valve leakage – which have a dramatic impact on patients’ quality of life.
With age, a heart valve can become stenotic, or narrowed, preventing it from properly opening and closing, which diminishes blood flow between the heart and the rest of the body. This causes the heart to weaken and function poorly; this condition is called aortic stenosis. Symptoms include fatigue, dizziness, chest pain/pressure, shortness of breath during activity, heart palpitations and fainting. Approximately one-third of patients who suffer from severe aortic stenosis are not eligible for open-heart surgery because they are deemed at too high risk.
Morristown Medical Center was one of 45 U.S. sites involved in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System.
Irwin Braunstein, a 79 year old male from Basking Ridge, NJ, a patient with symptomatic severe aortic stenosis, was seen by the heart valve team at Morristown Medical Center. The team determined he was too ill to undergo traditional aortic valve replacement and today Mr. Braunstein became the first in the tri-state area and third in the nation to receive a commercial CoreValve procedure.
“It is rewarding for Gagnon to be the first in the tri-state area and third hospital in the nation to offer this option in commercial use,” said John Brown, MD, Chief, Cardiovascular Surgery at Gagnon Cardiovascular Institute. “We continually strive to provide the most innovative and comprehensive cardiac care for 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.”
Most commonly, the CoreValve System is inserted into a patient via an artery in the leg, and the physician then guides it through the arteries into the heart at the site of the original aortic valve. Once in place, it takes over the original valve’s function and ensures that oxygen-rich blood flows out of the heart efficiently and circulates throughout the body.
The advanced design of the new device was developed to address the needs of the transcatheter aortic valve replacement (TAVR) patient population, serving a broad spectrum of severe aortic stenosis patients. The CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered via a small delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the CoreValve System enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
For more information about the newly FDA-approved Medtronic CoreValve System, visit their website or call 1-877-526-7890.
About the CoreValve U.S. Pivotal Trial (Illiofemoral Access)
The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance.
About Morristown Medical Center
Morristown Medical Center, located in Morristown, NJ, is a part of Atlantic Health System, one of the largest non-profit health care systems in New Jersey. Accredited by The Joint Commission, this year 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 heart surgeries than any other hospital in New Jersey, and is one of 20 facilities across the country to perform catheter-based repair and replacement of valves on both sides of the heart. The Society of Thoracic Surgeons awarded MMC three stars, its highest ratings. Only 12 percent of participating institutions achieve this high honor. Learn more >