Porter Regional Hospital announced that it is the first hospital in northwest Indiana/Chicagoland to complete an implant of the new Iforia implantable cardioverter defibrillator (ICD) as part of the ProMRI® trial. The trial, which is sponsored by BIOTRONIK, is currently the only FDA approved trial for investigational use of an ICD in an MRI (magnetic resonance imaging) scanner.
Each year thousands of patients receive ICDs which protect them from fatal heart rhythms. Until now, these patients, once they receive the implantable life-saving device, were not permitted to receive an MRI scan due to the risk the scanner may interfere with the function of the ICD. This is a challenge for patients and physicians since an estimated 50 to 75 percent of patients[i] with ICDs will need an MRI during their lifetime. The Center for Cardiovascular Medicine at Porter Regional Hospital is one of 35 leading U.S. investigational centers evaluating the safety and efficacy of BIOTRONIK’s IforiaProMRI® systems with Setrox and Linoxsmart leads during a MRI scan. The study will recruit and evaluate 172 patients across the U.S. All ICD systems in the study are currently commercially available, but await FDA approval specifically for use in the MRI environment.
According to Electrophysiologist Scott Kaufman, D.O., who completed the implant, the ICD marks an important first step in better addressing the critical need for improved imaging capabilities for heart rhythm patients. He explained that a large and growing number of our ICD patients require further diagnostics and, until now, could not receive them; and that this trial will provide much needed information toward expanding diagnostic capabilities for patients.
BIOTRONIK ProMRI®systems increase the potential to improve patient access to MRI scanning for patients who require pacemaker or ICD devices and give physicians more options to choose from without any therapeutic compromise. The Iforia ICD system, which is BIOTRONIK’s latest generation of small-sized ICDs being evaluated for ProMRI® technology, offers sophisticated shock-reduction capabilities, uncompromised longevity and daily monitoring through BIOTRONIK Home Monitoring®.
Considered a “heart hospital within a hospital,” the Center for Cardiovascular Medicine is located on the first floor of the new Porter Regional Hospital and provides advanced cardiovascular medicine in one centralized location. The center has received national recognition and accolades from the American Heart Association, Blue Cross and Blue Shield Distinction, Society of Chest Pain Centers, and the American Association of Cardiovascular and Pulmonary Rehabilitation. And most recently, Porter become the first health care facility in Indiana to receive full Atrial Fibrillation Certification status from the Society of Cardiovascular Patient Care (SCPC) and was awarded advanced certification in heart failure from The Joint Commission (the first hospital in northern Indiana and the second in the state to receive this honor).
Porter Health Care System has two hospital campuses and seven outpatient facilities serving Porter, Lake, LaPorte, Starke, Newton and Jasper counties. With more than 350 physicians representing 50 medical specialties on the medical staff, Porter Health Care System is committed to medical excellence and personalized, patient-centered care.