Product brief

Challenges with trial stimulators

A spinal cord stimulator lead is a flexible wire-like device with four, eight, or 16 small barrel shaped metal electrical contacts at each end. One end is designed to be connected to an impulse generator (battery) and the other end delivers the electrical impulse into the surrounding tissue and desired nerve target. 

Before implanting a stimulator system, patients undergo trials lasting 3 to 14 days. During a trial, a spinal cord stimulator lead, or peripheral Nurse stimulator lead is placed through the skin and advanced under x-ray guidance to sit next to a specified nerve or location along the spinal cord.

Electrical signals can block nerve impulses, significantly reducing the perception of pain. During the trial, it is imperative that the lead remains in place next to the nerve or desired location of the spinal cord.
Challenges with current solutions
Currently, leads are adhered to the skin using small pieces of tape called Steri-Strips or are sutured to the skin. Unfortunatley, both methods allow for significant lead migration. Also, both methods require a large clear adhesive bandage to be placed over the location where the lead enters the skin. 

Patients are not allowed to shower during the trial for fear of potential infection. They are also required to take antibiotics to negate the risk of potential infection within the central nervous system.

Patients often complain of significant skin, discomfort or irritation during the trial, as well as unpleasant side effects after taking antibiotics such as development of yeast infections or gastrointestinal problems. 

Introducing IAOMAI's percutaneos anchor

Lead Securement
- Designed to capture the externalized lead angle and provide strain relief.  - This solution is applicable to stimulator leads and indwelling IV catheters
Reduction in Skin Irritation
- Uses biocompatible adhesives (hydrocolloid) 
- Anchor body made of silicon to balance rigidity & comfort
- Small surface area with highly adhesive properties
Antibiotic 
- Integrated chlorhexidine-impregnated sponge