INGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging

Magnetic resonance imaging (MRI) is now the imaging modality of choice for many neurological and musculoskeletal conditions. In the past, implanted cardiac devices including pacemakers (PM) have been contraindicated by MRI scanner, due to the potential for adverse effects. Boston Scientific INGENIO 2 pacemakers and INGEVITY MRI pacing leads (ImageReady™) have been labeled as a “MR Conditional Pacing System” when used in the MRI environment under the labeled Conditions of Use. Interest in collecting human data to confirm performance of this pacing system when used in MRI environments is high, with the collection of data from patients undergoing an MRI scan of key importance.

- enrollment (after implant of pacemaker)
- MRI visit (at least 6 weeks after pacemaker implant, according to Conditions of use)
- standard of care follow up visit, one month after MRI visit.

Subjects are enrolled when already implanted according to standard medical guidelines for pacemaker implantation and will undergo a Magnetic Resonance Imaging (MRI) scan under the labeled Conditions of Use.