Objective: To support the safety of the Infinity DBS system with MR Conditional labeling.

Background: An international, multicenter, observational, prospective, single-arm, post-market clinical follow-up study was conducted to evaluate the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure is performed according to the approved guidance.

Method: The study aimed enrolling up to 74 subjects at up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling was approved, including the European Union (EU) and the United States. A minimum of 10 centers were included to ensure a broad range of MRI equipment setups and vendors. Subjects with leads-only or a full system configuration (leads, extensions and IPG) participated in the study. Subjects with levodopa-responsive Parkinson’s disease, primary or secondary dystonia, or disabling tremor, implanted with the Infinity DBS system with MR Conditional labeling have been enrolled. MRI should have been prescribed as standard of care procedure. Each subject underwent one 1.5T MRI procedure in conformity with the scanning regulations of the manufactor. The study collected adverse events (AEs) occurring during the procedure and through 1-month following. The primary endpoint was the rate of MRI-related adverse events.

Results: The study enrolled 62 subjects so far. Forty subjects were diagnosed with Parkinson’s disease, 21 with Essential Tremor and 1 with dystonia. Three subjects were withdrawn because no MRI scan was performed. Of the 59 remaining subjects, 34 were in the US and 25 in EU. A total of 40 subjects were scanned with a full system configuration and 19 with a leads-only configuration. MRI scans were performed with scanners from different manufacturers (Siemens 23/59 (39%), GE 34/59 (58%), and Philips 2/59 (3%)) with 1.5T settings. The scanned region of the body was primarily the head (54/59, 91.5%) but also included spine (4/59) and hip (1/59). No MRI-related adverse event was reported during the study for the 59 subjects, who completed a follow-up visit one month after the MRI scan.

Conclusion: This study reported that MRI scan performed according to instructions for use of the Infinity directional DBS system was a safe procedure in full system and leads-only configurations.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-of-mri-performed-with-leads-only-or-fully-implanted-dbs-system/