Technological innovation in spinal cord stimulation: use of a newly developed delivery device for introduction of spinal cord stimulation leads.
OBJECTIVE
The use of multiple cylindrical leads and multicolumn and single column paddle leads in spinal cord stimulation offers many advantages over the use of a single cylindrical lead. Despite these advantages, placement of multiple cylindrical leads or a paddle lead requires a more invasive surgical procedure. Thus, the ideal situation for lead delivery would be percutaneous insertion of a paddle lead or multiple cylindrical leads. This study evaluated the feasibility and safety of percutaneous delivery of S-Series paddle leads using a new delivery device called the Epiducer lead delivery system (all St. Jude Medical Neuromodulation Division, Plano, TX, USA).


METHODS
This uncontrolled, open-label, prospective, two-center study approved by the AZ St. Lucas (Ghent) Ethics Committee evaluated procedural aspects of implantation of an S-Series paddle lead using the Epiducer lead delivery system and any adverse events relating to the device. Efficacy data during the patent's 30-day trial also were collected.


RESULTS
Data from 34 patients were collected from two investigational sites. There were no adverse events related to the Epiducer lead delivery system. The device was inserted at an angle of either 20°-30° or 30°-40° and was entered into the epidural space at T12/L1 in most patients. The S-Series paddle lead was advanced four vertebral segments in more than 50% of patients. The average (±standard deviation [SD]) time it took to place the Epiducer lead delivery system was 8.7 (±5.0) min. The average (+SD) patient-reported pain relief was 78.8% (+24.1%).


CONCLUSIONS
This study suggests the safe use of the Epiducer lead delivery system for percutaneous implantation and advancement of the S-Series paddle lead in 34 patients.
AZ St. Lucas, Ghent, Belgium. david.loge@telenet.be
David
D
Logé
Olivier
O
De Coster
Stephanie
S
Washburn
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004567:Electrodes, Implanted / Q000009:adverse effects; D004824:Epidural Space / Q000033:anatomy & histology / Q000293:injuries / Q000502:physiology; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005548:Foreign-Body Migration; D006801:Humans; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D011788:Quality of Life; D013116:Spinal Cord / Q000502:physiology*; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods