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FDA approves ICD system for use with full-body MRI
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Medtronic announced that it has received FDA approval for an implantable cardioverter defibrillator that can be used with MRI scans.
According to a company press release, the Evera MRI SureScan ICD system is now approved for MRI scans conducted anywhere on the body, with no positioning restrictions. The approval requires that the system be used with Sprint Quattro Secure MRI SureScan DF4 leads in order to meet the condition for MRI use.
The approval follows results from the multicenter, randomized, prospective Evera MRI trial in 275 patients. Data presented at the 2015 Heart Rhythm Society Annual Scientific Sessions demonstrated that the device was safe and effective, with no effect of full-body MRI on the device’s ability to administer therapy.
Michael R. Gold
“Patients at risk for sudden cardiac arrest have long relied on ICDs to monitor their hearts, detect dangerous arrhythmias and deliver the life-saving therapy needed to survive,” Michael R. Gold, MD, PhD, chief of cardiology at the Medical University of South Carolina and principal investigator of the Evera MRI trial, said in the release. “The approval of an ICD that can be used in an MRI environment is crucial and can help provide patients with the peace of mind that they are receiving the best care available.”
Disclosure: Gold reports receiving consultant fees/honoraria from Biotronik, Boston Scientific, Medtronic and St. Jude Medical.