Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.

Spinal cord stimulation (SCS) is an established therapy for the treatment of chronic pain of the trunk and/or limbs. Standard practice includes a screening trial, typically lasting from 3 days to 7 days or more, for both the physician and the patient to evaluate whether SCS therapy is appropriate for permanent implantation. Screening trial success (hereafter referred to as a trial) is often considered predictive of long-term success of the therapy, although that has never been definitively demonstrated.

Boston Scientific Corporation (BSC) developed the Observational Mechanical Gateway (OMG) connectors to allow patients who previously underwent an SCS trial using Medtronic or St Jude Medical leads, operating room cables (OR-cables), and external trial stimulators (ETSs), to be able to connect to BSC commercially approved Spinal Cord Stimulation (SCS) trial systems to evaluate the BSC SCS therapy in the physician office setting prior to removal of the non-BSC leads.

Key Inclusion Criteria:

• Chronic intractable pain of the trunk and/or lower extremities
• History of trunk and/or lower extremity pain lasting at least 6 months
• Study candidate completed a spinal cord stimulation (SCS) trial of a FDA-approved non-Boston Scientific Corporation (non-BSC) system, exclusively for the treatment of chronic intractable pain of the trunk and/or lower extremities, that will not proceed to permanent implantation due to unsatisfactory treatment or in the physician's opinion received sub-optimal results
• Currently implanted with FDA-approved non-BSC SCS lead(s) exclusively in the thoracolumbar epidural space that are temporarily anchored for non-surgical removal at the termination of the screening trial period and which are approved for use with either the Observational Mechanical Gateway (OMG) A or OMG-M, per the OMG directions for use

Key Exclusion Criteria:

• Primary source of pain is cancer-related, pelvic, visceral or angina
• Investigator-suspected gross lead migration during the non-BSC trial period which may preclude the study candidate from receiving adequate SCS therapy
• Study candidate reports <10% paresthesia coverage of overall pain while running the preferred stimulation settings on the non-BSC SCS system at the end of the non-BSC SCS screening trial period
• Study candidate unwilling to tolerate implantation with an SCS system