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

Abbott Medical Devices74 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (16)

Banner University Medical Center Tucson Campus

Tucson, Arizona, United States

University of Colorado Hospital

Aurora, Colorado, United States

Neurosurgery One

Littleton, Colorado, United States

Emory University Hospital

Atlanta, Georgia, United States

Willis-Knighton Medical Center

Shreveport, Louisiana, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Wright State University & Premier Health

Fairborn, Ohio, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Inland Northwest Research

Spokane, Washington, United States

CHU Gabriel Montpied

Clermont-Ferrand, Auverg N, France

...and 6 more locations

Outcomes

Primary Outcomes

Rate of MRI-related Adverse Events

Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

Time frame: From MRI procedure through 1 month post-MRI procedure

Secondary Outcomes

Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode

Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful MRI mode 'turn on/off' functionality of the MRI mode was assessed.