BIOTRONIK announced that the FDA has approved its Entovis single chamber (SR-T) and dual chamber (DR-T) pacemaker systems with ProMRI technology and Setrox 53 and 60cm leads, making the system magnetic resonance (MR) conditional in patients with arrhythmias.
FDA approval is based on an initial clinical study and follow-up to assess full-body MRI scans with the pacemakers. The company’s existing single- and dual-chamber Entovis pacemaker systems and Setrox pacing leads were previously approved by the FDA for general use, but not in an Magnetic Resonance Imaging (MRI) environment.
It is recommended that patients with the Entovis SR-T and DR-T pacemaker systems with ProMRI technology alert healthcare professionals about their device if undergoing radiology. Prior to the MRI, the pacemaker system will be programmed with limited therapy functionality and reprogrammed post-scan.
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