Oak Lawn, Ill. -- Question: What’s brand-new, tiny, does not require surgery to use and has the potential of improving the quality of life for heart patients?
Answer: the Nanostim™ leadless pacemaker, the world’s first retrievable, non-surgical pacing technology, which is being implanted in select patients with bradycardia (too slow a heart rate) as part of the LEADLESS II Clinical Trial.
Advocate Christ Medical Center, which is one of about 50 centers in the United States participating in the prospective, non-randomized, international study, recently, became one of the first institutions in Illinois to implant this new St. Jude Medical device. To date, only a limited number of such devices have been implanted in patients in this country, said Manoj Duggal, MD, the cardiologist who implanted the device in the first Christ Medical Center patient.
The study is designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients whose heart problems make them candidates for the new device. The study is expected to enroll 670 patients nationwide.“If shown effective, this new pacemaker will prove a boon to patients whose hearts beat too slowly,” Dr. Duggal stated. “Not only is the device less than 10 percent the size of a conventional pacemaker, it can be implanted minimally invasively inside the heart and requires no lead or surgical pocket -- qualities that should enhance patient comfort.”
The Nanostim leadless pacemaker can be readily positioned on the right side of the heart without surgery. The device is delivered through a catheter, which is inserted into a patient’s femoral artery through a small incision in the thigh. Because of the device’s small size, coupled with the lack of a surgical pocket and the exclusion of a lead that must be connected to a battery, the technology is expected to reduce complications, such as pocket-related infections and lead failure.
Study coordinators also anticipate the device will significantly improve patients’ quality of life, because the visible lump and scar created at the implant site of a conventional pacemaker will be eliminated and the kinds of patient activity restrictions routinely put in place to prevent dislodgement or damage to the leads of traditional pacemakers will no longer be required. “Patients will be allowed to continue living active, uninhibited lifestyles,” Dr. Duggal stated.
The new technology is supported by the St. Jude Medical Merlin™ Programmer, which also is used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).
Cardiac pacemakers monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient’s specific physiological requirements. More than four million people worldwide carry an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive such devices annually.
The Nanostim leadless pacemaker received a CE Mark approval in 2013 and is now available in select European markets, but is not yet available for sale in the U.S.
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About Advocate Christ Medical Center
Advocate Christ Medical Center is part of Advocate Health Care, which is one of the nation’s leading health care networks. A not-for-profit, 694-bed, premier teaching institution with more than 1,200 affiliated physicians, Christ Medical Center is a leader in health care and one of the major referral hospitals in the Midwest in a number of specialties, including cardiovascular services, heart, kidney and lung transplantation, neurosciences, oncology, orthopedics and women’s health. The hospital also has one of the busiest Level I trauma centers in Illinois providing emergency care for more than 100,000 patient visits annually and is a leader in breakthrough technologies, including eICU® (electronic intensive care unit) monitoring, robotic da Vinci Surgery System® and CyberKnife® Radiosurgery. For the last three years (2012-2014), the medical center has been named to the Truven Health 100 Top Hospitals® list. U.S.News & World Report has ranked the medical center among the nation’s leading providers for cardiology and heart surgery, geriatric medicine, gynecology and neurology/neurosurgery and rated it overall as being among the top three hospitals in Illinois. The hospital is also recognized by the American Nurses Credentialing Center (ANCC) as a Magnet Center. Magnet status represents the highest honor in the nursing profession. To obtain more information or to visit our newsroom, log on to: www.advocatehealth.com/christ.