title: Use of a newly developed delivery device for percutaneous introduction of multiple lead configurations for spinal cord stimulation.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Interventional Pain Management, Jupiter, FL, USA.
authors.forename: Louis J
authors.initials: LJ
authors.lastname: Raso
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Deer
authors.forename: Sandford M
authors.initials: SM
authors.lastname: Schocket
authors.forename: Jack A
authors.initials: JA
authors.lastname: Chapman
authors.forename: Luis E
authors.initials: LE
authors.lastname: Duarte
authors.forename: Rafael
authors.initials: R
authors.lastname: Justiz
authors.forename: Kasra
authors.initials: K
authors.lastname: Amirdelfan
authors.forename: Richard M
authors.initials: RM
authors.lastname: Paicius
authors.forename: Yeshvant A
authors.initials: YA
authors.lastname: Navalgund
authors.forename: George E
authors.initials: GE
authors.lastname: Girardi
authors.forename: Neal E
authors.initials: NE
authors.lastname: Coleman
authors.forename: Michael
authors.initials: M
authors.lastname: Verdolin
authors.forename: Nameer
authors.initials: N
authors.lastname: Haider
authors.forename: Steven
authors.initials: S
authors.lastname: Rosen
authors.forename: Mark D
authors.initials: MD
authors.lastname: Netherton
authors.forename: Michael Chad
authors.initials: MC
authors.lastname: Owens
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Bennett
authors.forename: Jason
authors.initials: J
authors.lastname: Rosenberg
authors.forename: Shaun
authors.initials: S
authors.lastname: Jackson
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Nelson
authors.forename: Timothy T
authors.initials: TT
authors.lastname: Davis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000628:therapy*; D004824:Epidural Space / Q000502:physiology*; D005260:Female; D006801:Humans; D007854:Lead / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010549:Personal Satisfaction; D010820:Physicians / Q000523:psychology; D012189:Retrospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods*; D004561:Transcutaneous Electric Nerve Stimulation; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007854:Lead
keywords: Chronic pain; Epiducer; lead configuration; percutaneous; spinal cord stimulation