Use of a Newly Developed Delivery Device for Percutaneous Introduction of Multiple Lead Configurations for Spinal Cord Stimulation
| Autor: | Matthew T Bennett, Nameer Haider, Michael H. Verdolin, Christopher Nelson, Sandford Matthew Schocket, Louis J. Raso, Luis E. Duarte, Steven M. Rosen, Kasra Amirdelfan, Mark D. Netherton, Timothy R. Deer, Jason Rosenberg, Jack A. Chapman, George E. Girardi, Shaun P. Jackson, Rafael Justiz, Michael Chad Owens, Yeshvant A. Navalgund, Timothy T. Davis, Neal E. Coleman, Richard Paicius |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Epidural Space Male medicine.medical_specialty Percutaneous medicine.medical_treatment Personal Satisfaction Young Adult Physicians medicine Humans Paddle Lead (electronics) Adverse effect Aged Retrospective Studies Aged 80 and over Spinal Cord Stimulation business.industry Laminectomy General Medicine Middle Aged medicine.disease Epidural space Surgery Treatment Outcome Anesthesiology and Pain Medicine medicine.anatomical_structure Lead Neurology Transcutaneous Electric Nerve Stimulation Female Observational study Neurology (clinical) Medical emergency Chronic Pain Lead Placement business |
| Zdroj: | Neuromodulation: Technology at the Neural Interface. 17:465-471 |
| ISSN: | 1094-7159 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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