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

Purpose

This study will support the claim that MRI procedures are safe when performed according to the approved guidance.

Criteria

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.

Subject is scheduled to undergo a MRI procedure

You Cannot

Have another implanted device (active or passive implanted device) that prohibits safe scanning.

Have previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason

Details

Patients will undergo standard of care MRI as scheduled.  The Infinity device will be interrogated before and after the procedure.  A 30 day follow-up will be scheduled at which time the device will be interrogated

Interested in more information on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613

Interested in more information? Contact Us:

Dr. Jessica Wilden, M.D., Principal Investigator

IRB: Willis-Knighton
IRB Number: 19.0002
Trial Type: NA
Sponsor: Abbott