IMPLANTABLE DEVICE TO TREAT SUDDEN CARDIAC ARREST APPROVED FOR USE IN MRI SCANS; METHODIST HOSPITALS FIRST TO IMPLANT IN NWI - December 4, 2015

Methodist Hospitals in Gary and Merrillville Indiana is the first hospital in NWI offering patients the first implantable cardioverter defibrillator (ICD) system approved for use with magnetic resonance imaging (MRI) scans. Many patients rely on ICDs to detect irregular heartbeats and deliver life-saving therapy to restore a normal heartbeat. However, until now, patients with ICDs have not been able to receive MRI scans because of potential interactions between the MRI and the device function, which might result in risk to patients. These MRI restrictions have resulted in a critical unmet need as data have shown that, within four years, more than one-third of patients with ICDs are likely to need an MRI.[i]

“Patients with ICDs are often older adults with other serious medical conditions that require an MRI for diagnosis,” said Dr. Andre Artis, Cardiologist and Medical Director of the Heart and Vascular Institute at Methodist Hospitals. “We’re grateful to have this game-changing technology that helps treat cardiac arrest and enables patients to access MRIs, which allows us to provide even better care.”

An ICD is a small implantable heart device that is placed under the skin typically just below the collarbone on the left side of the chest. For patients at risk for a life threatening cardiac arrhythmia or sudden cardiac arrest, a sudden, abrupt loss of heart function that can result in death if not treated within minutes, ICDs may be prescribed to continuously monitor heart rate and deliver an electrical signal to correct a life-threatening heart rate, if detected.

MRI is an imaging test used regularly for a wide range of diagnoses including conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and back pain, all which are prevalent among older adults.

The Evera MRI™ SureScan® ICD System from Medtronic has been FDA approved to allow for MRI scans on any part of the body. The system includes design enhancements from previous generation devices that allow it to safely undergo full-body MRIs, while maintaining the same longevity, proven shock reduction and physical size and shape of the original Evera ICD. The device is paired with the Sprint Quattro® Secure MRI SureScan® DF4 leads, backed by more than 10 years of proven performance with active monitoring,[ii] now tested for safe use during an MRI.

The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the randomized, controlled Evera MRI Clinical Trial that demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.

About Methodist Hospitals

Methodist Hospitals is a community-based, not-for-profit health system with two full-service acute care facilities in Gary and Merrillville, Indiana, that has been leading the way to better health for residents of Northwest Indiana for almost 100 years. Methodist Hospitals offers a number of award – winning programs, including its Neuroscience, Oncology, Heart and Vascular Institutes and Breast Care Center. Its range of services also includes Bariatric Surgery services, Emergency & Trauma services, Orthopedics & Spine services, comprehensive Rehabilitation services, Behavioral Health and Home Health Services.

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[i] Nazarian S, Reynolds M, Ryan M, et al. Estimating the Likelihood of MRI in Patients After ICD Implanation: A 10-Year Prediction Model. J Am Coll Cardiol. 2015;65(10S)

[ii] Medtronic Product Performance Report, 2012 Second Edition, Issue 66.