Milwaukee, Wis. – Aurora St. Luke's Medical Center is the first and only Wisconsin hospital to implant the world's first investigational self-contained leadless pacemaker; the Nanostim™ leadless pacemaker. Developed for patients with bradycardia─a heart rate that is too slow─the Nanostim device is designed to be placed directly in a patient's heart, through a vein in the leg, and without an incision in the chest.
Richard Kasprowicz of Union Grove, Wisconsin was the first to receive the device because he experiences low heart rates. The implant took place as part of the LEADLESS II trial, an international clinical study designed to evaluate the safety and effectiveness of this device from St. Jude Medical.
The first implant procedure in Wisconsin was performed by Imran Niazi, M.D., the principal investigator for this study and electrophysiologist at Aurora St. Lukes. Dr. Eyman Mortada, electrophysiologist at Aurora St. Luke's, is also trained to implant this investigational device.
"This is a revolutionary technology," said Dr. Niazi. "By avoiding invasive surgery and using interventional techniques for implanting pacemakers, we could reduce patient discomfort and cost significantly. Surgical risk─such as infection─and recovery time in the hospital is greatly reduced. This new technology has the potential to have an enormous impact on cardiac care for the nearly 700,000 people worldwide that receive pacemakers each year."
Implanted via the femoral vein with a steerable catheter, the leadless pacemaker offers a minimally invasive approach compared to traditional pacemaker procedures that require more extensive surgery. The miniaturized device is designed to be fully retrievable so that it can be readily repositioned during the implant procedure and later retrieved if necessary. The device can be monitored wirelessly at home or in clinic.
The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and weighs only 2 grams. It is the least invasive pacing technology available today. The small size of the device and lack of a subcutaneous surgical pocket, coupled with the exclusion of leads (wires to the heart), is expected to improve patient comfort and reduce complications, including device pocket-related infection and lead failure. The elimination of the visible lump and scar at a conventional pacemaker's implant site, in addition to the removal of patient activity restrictions that are routinely put in place in an attempt to prevent dislodgement or damage to a conventional lead, could potentially improve the quality of life for patients by allowing most to continue living active, uninhibited lifestyles immediately after the implant.
"Aurora St. Luke's Medical Center is continuously looking for ways to improve the health of our community, and such research studies are key," said Dr. Randall Lambrecht, president of the Aurora Research Institute. "The Aurora Research Institute is currently participating in more than 400 clinical trials and is continually investing in ways to improve patient-centered outcomes."
Cardiac pacemakers monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device.
The Nanostim leadless pacemaker received CE Mark approval in 2013 and is now available in select European markets. The device is not available for sale in the U.S., but is available to appropriate patients as part of an FDA approved clinical study.
To learn more about Aurora's clinical trials, visit aurora.org/research.
Aurora Health Care is a not-for-profit Wisconsin-area health care provider and a national leader in efforts to improve health care quality. Aurora offers services at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois. Aurora is Wisconsin's most comprehensive health care provider and the state's largest private employer. Aurora serves more than 1.2 million patients every year via a comprehensive network of facilities, services and providers, including 15 hospitals, 159 clinics, 70 pharmacies and 30,000 amazing Caregivers. As evidenced by more than 400 active clinical trials, Aurora is dedicated to delivering innovations to provide the best possible care today, and to define the best care for tomorrow.
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