STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads (SECURE Study)

The purpose of the Spinal Cord Stimulator (SCS) trial system is to determine if spinal cord stimulation is effective in adequately relieving the patient's pain and or improving function. Dorsal column stimulator trials are performed in a hospital outpatient setting. Under fluoroscopy, the physician inserts a trial lead into the epidural space. The lead is connected to a cable and an external generator worn over the body. Via the external generator, the physician tests various lead positions and stimulation parameters to identify optimal positions and settings. Then the patient is sent home with the temporary device in place. After the trial period of anywhere between 7 to 10 days, the physician meets with the patient to evaluate the effect of spinal cord stimulation and to determine if the permanent implantation is appropriate for the patient. After the discussion, the physician proceeds to remove the trial leads after carefully removing the adhesives tapes and gentle traction of leads.

Issues faced with trial lead anchoring: During the procedure after the trial leads are placed in the desired segment of the spinal cord, the remaining portion of the leads at the insertion site are coiled, and along with the device it is adhered to the skin by using wide soft cloth surgical tapes. Also, to absorb the blood and fluid oozing at the lead insertion site, soft surgical gauze is used as an absorbent pad. During this part of the procedure, there is a risk of lead displacement either while coiling the leftover lead or while using the wide surgical tape. Also, using only the soft, absorbent surgical gauze might increase the incidences of potential infection.

Proposed solution: Stimfix Trial lead anchoring system comes with the right and left clips which can hold the respective side of the leads above the skin. This system reduces the rate of displacement of the leads in the epidural space. The device is made of flexible polyurethane that allows for malleability during use for the one week. In addition foam that is silver impregnated and absorbable allows for potential reduced rates of infection and need for external absorbent pad.

Aim 1: A total of 50 subjects who are undergoing dorsal column stimulator trial will be studied and placed on the SECURE study where their trial leads will be anchored using the StimfixTM system. The trial duration will be for seven days as per standard of care.