Use of a newly developed delivery device for percutaneous introduction of multiple lead configurations for spinal cord stimulation.

OBJECTIVE: The Epiducer lead delivery system is a novel lead delivery device that can be used to percutaneously implant S-Series paddle leads (St. Jude Medical, Plano, TX, USA) as well as multiple percutaneous leads obviating the need for laminectomy and/or multiple needle sticks, respectively. This study evaluates the safety and usage of the Epiducer lead delivery system. METHODS: An Institutional Review Board-approved observational data collection study was conducted to evaluate usage patterns of the Epiducer system. In addition to the number and frequency of different lead configurations, the following procedural aspects of the surgery were recorded during the evaluation: angle of entry, distance from entry to final lead placement, and physician feedback. Descriptive statistics on adverse events, procedural aspects, and patient outcomes were compiled. RESULTS: Data were collected from 163 patients across 25 investigational sites. Physicians successfully implanted patients using the Epiducer during 89% of the procedures. Seven possible lead configurations were implanted. There were 96% and 92% of physicians "satisfied" or "very satisfied" with accessing the epidural space and placing multiple leads with the Epiducer delivery system, respectfully. Eighty-nine percent of physicians were "satisfied" or "very satisfied" with implanting an S-Series paddle lead using the Epiducer delivery system. Ninety-five percent of physicians were "satisfied" or "very satisfied" with the Epiducer delivery system overall. Ten patients (6%) experienced adverse events. CONCLUSION: Results suggest that the Epiducer delivery system allows for the safe and successful percutaneous implantation of paddle leads and/or multiple lead configurations. Furthermore, physicians are satisfied with the Epiducer delivery system.

Peripheral nerve field stimulation in chronic abdominal pain.

INTRODUCTION: Spinal Cord Stimulation (SCS) has become an accepted therapeutic modality for the treatment of intractable pain syndromes, primarily used today in the settings of failed back surgery syndrome, neuropathic back and limb pain. The use of spinal cord stimulators for peripheral nerve field electrostimulation is becoming increasingly recognized as a safe, effective alternative for chronic pain conditions that are refractory to medical management and do not respond to traditional dorsal column stimulation. Advances in technology have allowed for minimally invasive percutaneous placement of multipolar leads with complex programmable systems to provide patient- controlled relief of pain in precisely targeted regions. With these improvements in hardware, the use of Peripheral Nerve Field Stimulation (PNFS) appears to have an untapped potential for providing patients with pain relief for a wider range of underlying conditions than was previously believed possible. We present three cases, each with a different etiology of chronic abdominal pain: one with inguinal neuralgia, one with chronic pancreatitis, and one with pain following liver transplant. Each patient was refractory to conventional medical approaches. For all three patients, PNFS provided significant relief from pain, enabling patients to decrease or discontinue their opioid medications and to enjoy significant improvement in their quality of life. We conclude that PNFS is a safe, effective and minimally invasive treatment that may be used successfully for a wide variety of indications including chronic abdominal pain.