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The Medical Center, Navicent Health Implants First Device to Treat Sudden Cardiac Arrest Approved for Use in MRI Scans

First Patient to Receive Medtronic Evera MRI SureScan ICD Doing Well

MACON, GA (Wednesday, May 4, 2016) - The Medical Center, Navicent Health (MCNH) is pleased to now offer patients the first implantable cardioverter defibrillator (ICD) system approved for use with magnetic resonance imaging (MRI) scans. Physicians at MCNH implanted the first MRI-safe ICD in patient Emory Olds on March 22, 2016.

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 critically unmet need as data have shown that, within four years, more than one-third of patients with ICDs are likely to need an MRI.

“Patients with ICDs are often older adults with other serious medical conditions that require an MRI for diagnosis. We are pleased to offer patients the latest in ICD-technology in order to improve treatment for cardiac arrest as well as other conditions that may require access to MRIs,” said Dr. Christopher Hendry, Chief Medical Officer for MCNH.

Although patient Emory Olds, the first to receive the Evera MRI"„¢ SureScan® ICD System at MCNH, is otherwise in good health, he rests comfortably knowing that he can undergo an MRI scan in the future if ever needed. The 58 year old resident of Jesup, Ga. enjoys the outdoors, particularly fishing, hunting, kayaking and riding motorcycles with his wife and daughter. With Evera MRI"„¢ SureScan® ICD System, he will be able to continue that active lifestyle for many years to come.

“In 2005, I had a heart attack, and eventually received a pacemaker in August of 2007. The battery was dwindling on my old device, and so that's why Dr. Sogade did this procedure to place this new device. I've been pleased with the device, and now I have a new fancy one. It is cellular, and if I have a cellular signal, I can send in data to my doctor's office or it could alert the doctor's office, either way. Not only that, it's MRI compatible. I don't need an MRI today, but one day I might, so why pass up that opportunity in technology?” said Olds.

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.

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.[iii]

[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.

[iii] 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.