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FDA approves clinical trial expansion for Biotronik ICD
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Biotronik announced that the FDA has approved expansion of an ongoing trial of the company’s ProMRI technology for implantable cardioverter defibrillators, in order to assess its use during MRI scans.
The initial phase of the trial, completed in November 2013, evaluated the safety of the Entovis pacemaker during MRI scans in areas other than the chest, according to a press release. The FDA is currently reviewing the premarket application for this device. The second phase, which is ongoing and will proceed concurrently with the newly approved phase, will assess the safety of the Entovis pacemaker during MRI scans, including cardiac and thoracic spine scans. More than 100 of a planned 245 patients have been enrolled in the second phase thus far, according to the release.
The approved third phase will assess 172 patients with ICDs enrolled from 35 investigational centers throughout the United States, in order to determine the safety and efficacy of the Iforia platform of ICDs with Setrox and Linoxsmart leads during an MRI scan. The devices incorporated in the study are available commercially, but not yet approved for use during MRI.
“This technology will finally allow full diagnostic capabilities for our patients who are more likely to need MRI scans,” Theofanie Mela, MD, director of the Pacer and ICD Clinic at Massachusetts General Hospital in Boston, stated in the release. “… ICD patients are frequently recommended for MRI scans, but until now they have been unable to receive them. We are very excited to be participating in the ProMRI trial.