TRIALON™
FIXATION DEVICE
TrialOn™ is the only fixation device designed specifically for trial lead fixation in Spinal Cord Stimulation (SCS) proceduresA simple and intuitive solution, the TrialOn™ Fixation Device aims to standardize how physicians anchor leads for their trial SCS procedures
After revolutionizing the permanent SCS implant procedure with the launch of the Lead Loop™ Suture Anchor, many physicians asked if we had a fixation solution for trial procedures After further market research, we realized there is little consensus, and no standard method for securing trial leads. Existing methods are cumbersome, time consuming or utilize materials not designed or optimized for SCS We know there was a better way to approach the procedure. One that enables physicians to be more efficient and that helps to improve patient outcomes Much like permanent procedures, lead migration is a significant contributor to failed SCS trials (1). Further, given increased data on the benefits of SCS devices (2), we recognize there is a valuable opportunity to ensure patients and physicians have the greatest opportunity for success in SCS trials Our objective is to mitigate lead migration as a variable affecting the success of SCS trials A simple and intuitive solution, the TrialOn™ Fixation Device aims to standardize the method of securing leads for trial SCS procedures |
The TrialOn™ Fixation Device is a sterile adhesive fastener for trial SCS procedures. It is designed to adhere to skin and secure a percutaneous Spinal Cord Stimulation (SCS) Lead to assist in minimizing movement of the lead during trials. Please see our Instructions For Use (IFU) document for important, additional details.
TrialOn™ Features and Benefits
TrialOn™ Post-Application: |
TrialOn™ in Action
Notes:
(1) Michael D. Osborne, Salim M. Ghazi, Scott C. Palmer, Katherine M. Boone, Christopher D. Sletten, Eric W. Nottmeier; Spinal Cord Stimulator—Trial Lead Migration Study, Pain Medicine, Volume 12, Issue 2, 1 February 2011, Pages 204–208, https://doi.org/10.1111/j.1526-4637.2010.01019.x
(2) Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. Journal of Pain Research. 2016;9:481-492. doi:10.2147/JPR.S108884, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938148/
(1) Michael D. Osborne, Salim M. Ghazi, Scott C. Palmer, Katherine M. Boone, Christopher D. Sletten, Eric W. Nottmeier; Spinal Cord Stimulator—Trial Lead Migration Study, Pain Medicine, Volume 12, Issue 2, 1 February 2011, Pages 204–208, https://doi.org/10.1111/j.1526-4637.2010.01019.x
(2) Verrills P, Sinclair C, Barnard A. A review of spinal cord stimulation systems for chronic pain. Journal of Pain Research. 2016;9:481-492. doi:10.2147/JPR.S108884, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938148/
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