Biotronik‘s Iforia ProMRI implantable cardioverter defibrillator is safe for use in 1.5T MRI scanners, researchers announced today at the Heart Rhythm Society’s annual meeting in Boston.
The 170-patient study was the 1st clinical trial for MRI-conditional ICD systems in the U.S., primary investigator Dr. Khaled Awad of the University of Alabama at Birmingham’s School of Medicine told reporters today.
During the study 403 ventricular arrhythmias were detected in 39 subjects post-MRI, with all episodes appropriately detected and treated by the Iforia ICD, Awad said. But the data should only be applied to the specific MRI conditions examined during the study, he cautioned.
"There was no impact on the device’s main function, which is detecting and treating ventricular arrhythmias. So all the patients that had episodes of life-threatening arrhythmias were actually appropriately protected and treated by the device. There were no failed therapies," Awad said.
The study data were submitted to the FDA to support approval of the Iforia ICD for use with MRIs, Biotronik said in a press release.
"Throughout the ProMRI clinical trial, we have scanned more than 500 patients without any safety concerns. Many patients with ICDs remain unable to obtain the diagnostic procedures they need, and we look forward to removing that barrier using the evidence these investigators have gathered," Biotronik vice president Kevin Mitchell said in a prepared statement.