Medical City Dallas September 24, 2015

ICD Now Being Implanted at Medical City Dallas Hospital

Medical City Dallas is now 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.¹

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 ², 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. ³

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

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

[1] Gold MR, Torsten S, Schwitter J, et al. Full-Body MRI Scanning in Patients with an ICD: Primary results of the randomized Evera MRI Study. J Am Coll Cardiol. Published online May 14, 2015.