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Physician and patient demand validates market need for MRI accessible cardiac implanted devices.
August 31, 2015
By: Michael Barbella
Managing Editor
Call it a sign of the times. Since the March launch of the ProMRI Eluna pacemaker system, the majority (60 percent) of pacing devices sold by Biotronik SE & Co. Kg are approved for use during magnetic resonance imaging (MRI) scans, the company recently announced. “The majority of pacemaker patients are over the age of 651 and most are likely to have a clinical need for an MRI scan after their device is implanted,” said J. Rod Gimbel, M.D., cardiac electrophysiologist at Cardiology Associates of East Tennessee, a practice with offices in Knoxville and Lenoir City. “The pacemaker patient population typically has multiple orthopedic, oncologic, neurologic and cardiovascular co-morbidities that are best understood with MRI; thus, it is crucial that we implant pacemakers that allow continued unfettered access to MRI. In my practice, I implant MRI conditional devices and leads at every opportunity to do so, as I believe MRI conditional devices are the standard of care.” Biotronik’s ProMRI technology allows patients to undergo full-body MRI scans with both single-chamber and dual-chamber pacemakers when implanted with the company’s specially designed and tested pacing leads. Biotronik executives claim the firm has the most comprehensive offering of devices and leads approved for use in MRI scans outside the United States. “Demand from physicians and patients for MRI conditional pacemakers have increased dramatically since Biotronik released its complete line of ProMRI pacemakers and leads in the U.S. Most physicians understand the need and clinical benefits of the technology,” said Paul Woodstock, executive vice president of Sales and Marketing at Biotronik. “Offering the most current products is releasing pent-up demand in the marketplace.” More than 6 million people aged 65 or older undergo an MRI scan in the United States every year2 and 20 percent of pacemaker patients need an MRI within the first two years of implant3. According to the Mayo Clinic, approximately 75 percent of patients who have an implantable cardiac device will need an MRI in their lifetime.4 Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore. References:
1 Greenspon AJ et al. Journal of American College of Cardiology. 2012, 60(16). 2 Zhan C et al. Journal of General Internal Medicine. 2008, Jan. 23 Suppl. 3 SureScan Post Approval Study presented in May 2013 at Heart Rhythm Society Meeting. 4 www.mayoclinic.org, Medical Professionals, “New protocols allow for MRI in selected pacemaker patients.”
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