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

Purpose

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.

Conditions

  • Movement Disorders
  • Parkinson Disease
  • Essential Tremor
  • Tremor
  • Dystonia

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Infinity DBS System with MR Conditional labelling The Infinity DBS system with MR Conditional labelling includes a primary cell implantable pulse generator designed to deliver low-intensity electrical pulses to targeted structures in the brain.
  • Device: Infinity DBS System with MR Conditional labelling
    Patients implanted with the Infinity DBS system with MR Conditional labeling

More Details

Status
Completed
Sponsor
Abbott Medical Devices

Study Contact