A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

Inclusion Criteria:

1. Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
2. Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
4. Subject is willing and able to comply with study requirements.

Exclusion Criteria:

1. Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
4. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
5. Subject is currently participating in another clinical investigation that may confound the results of this study.