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New ICD system available for use with MRI scans
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Biotronik announced that it has received FDA approval for use of its Iperia implantable cardioverter defibrillator systems with MRI scans, according to a press release.
The ProMRI technology allows patients to have 1.5 Tesla MRI scans without an exclusion zone. The Biotronik ProMRI ICD system approval covers the Iperia DR-T in both DF-1 and DF-4 configurations and the Iperia DX System, which combines single- and dual-chamber devices. Also included in the approval is the Inventra ProMRI DX, which features ultra-high energy (42 Joules) on the first shock. The devices are MR conditional when used with appropriate leads to complete the approved ProMRI system, according to the release.
In the ProMRI study, investigators found that the ability of ICDs with this technology to detect and treat ventricular arrhythmias was not compromised when the device was placed into MRI mode.
“We have truly entered a new era of total health care for cardiac rhythm management patients who rely on ICDs to monitor their hearts and provide life-saving therapy when demanded,” Mark A. Marieb, MD, clinical director of electrophysiology at Yale-New Haven Hospital and Yale School of Medicine and investigator for the ProMRI study, stated in the release. – by Tracey Romero