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TRIALON™
​FIXATION DEVICE

TrialOn™ is the only fixation device designed specifically for trial lead fixation in Spinal Cord Stimulation (SCS) procedures

A 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
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IFU
​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

  • Simple intuitive application, with easy to remove adhesive liners
  • Maintains a low profile, improving patient comfort throughout the trial
  • No hard backings, rigid angles, or firm foams allowing the device to conform easily to the patients’ natural body contours, and ensure the SCS lead remains flush to its entry point
  • Materials include non-irritant, perspiration and water resistant medical grade adhesive, and soft breathable foam to provide confident fixation
  • Designed for long term wear applications, adhesive is strong enough to remain in place through trial phase, yet gentle enough for easy removal from skin


TrialOn™ Post-Application:

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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/​

SUTURE CONCEPTS
100 CUMMINGS CENTER, SUITE 414-G
BEVERLY, MA 01915

1.800.762.9926

[email protected]
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