Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Sponsor:
Abbott Medical Devices
Brief Summary:
The purpose of this post-market study is to characterize the clinical performance of the
Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator
(IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller
and related system components.
Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator
(IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller
and related system components.
Criteria
Inclusion Criteria:
– Subject is able to provide informed consent;
– Subject is diagnosed with Parkinson’s disease (PD) and has been recommended to receive
an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN),
or has received an implant of an Infinity system with bilateral lead implants in the
STN;
– Subject must be available for follow-up visits.
Exclusion Criteria:
– Subject is not a surgical candidate;
– In the investigator’s opinion, the subject is unable to tolerate multiple programming
sessions within a single setting;
– Subject is unable to comply with the follow-up schedule.
Locations
- Kaiser Permanente Sacramento Medical Center, Sacramento, California, United States, 94229
