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October 14, 2014, Morristown, NJ – Gagnon Cardiovascular Institute at Morristown Medical Center recently started a phase III clinical trial of the Micra™ Transcatheter Pacing System (TPS). The investigational device is the world’s smallest cardiac pacemaker for patients with bradycardia- a condition characterized by a slow or irregular heart rhythm, usually fewer than 60 beats per minute.
One-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS pacemaker is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned or retrieved if needed. The miniature device does not require the use of wires, known as “leads,” to connect to the heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace the heart through an electrode at the end of the device.
“This miniaturized technology is designed to provide patients with the advanced pacing technology of traditional pacemakers via a minimally invasive approach,” said Robert Coyne, MD, principal investigator of the clinical trial at Morristown Medical Center. “We are proud that Morristown Medical Center was selected among an elite group of institutions to take part in this clinical trial. If positive, the results of the trial could potentially benefit the more than one million people globally who receive pacemakers each year.”
In contrast to current pacemaker implant procedures, the Micra TPS implant does not require a surgical incision in the chest and the creation of a “pocket” under the skin. This eliminates a potential source of complications, and any visible sign of the device. The Medtronic Micra TPS is an investigational device worldwide.
The efficacy and safety of the Micra TPS is being evaluated in a global clinical trial that will enroll up to 780 patients at approximately 50 centers. Morristown Medical Center is one of few hospitals in the region to offer this clinical trial.
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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 and heart surgery, gynecology, geriatrics, orthopedics and pulmonology. Morristown Medical Center also ranked as a “Best Regional Hospital” for cancer, diabetes & endocrinology, neurology and neurosurgery, as well as gastroenterology & GI Surgery, nephrology 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. For more information, please visit AtlanticHealth.org/Morristown. For more information, visit AtlanticHealth.org/Morristown.