EXPERIENCE PNS™ SYSTEM
The Injectrode® lead is placed through a needle in a single clinic visit, with one end accessible at the skin. The pulse generator is worn on the surface for 30 days, and then the lead is removed.
Start with an injection. Decide after thirty days.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE ONLY. NOT FOR SALE.
WHERE NEUROMODULATION CAN BEGIN
What if it could start with an injection?
Neuromodulation is an option for patients whose pain has not responded to medication. Most current systems require surgery to place a stimulator.
The Experience PNS System starts differently. A needle and local anesthetic, in a clinic visit. The patient goes home the same day and uses the system on a schedule set with their clinician. At the end of 30 days the Injectrode lead is removed, and what comes next is a separate decision.
WHAT'S VISIBLE OUTSIDE THE BODY
The Injectrode lead stays reachable.
In Experience PNS, the proximal end of the Injectrode lead remains accessible at the skin and connects directly to the external pulse generator. This design decision makes both placement and the removal small procedures.
01 Placement
Performed under local anesthesia with ultrasound or fluoroscopic visualization. The delivery needle is marked so the physician knows which portion of the device is deploying at each stage. The needle is withdrawn, leaving the Injectrode lead in place. The helix is designed to conform to the anatomy and hold position without tines, hooks, or sutures.
02 Therapy
The external pulse generator attaches magnetically to a patch worn on the skin and delivers waveforms through the accessible end of the Injectrode lead. The patient uses the system at home on a program set with their clinician. Stimulation can be adjusted, paused, or stopped under clinician supervision at any point, without a procedure.
03 Removal
The proximal end of the Injectrode lead has stayed accessible at the skin throughout the course, so no opening is needed to reach it. The device is grasped and drawn out under gentle traction, and nothing is left in place.
EXPERIENCE PNS PROCEDURE OVERVIEW
Unboxing and Procedure Overview
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE ONLY. NOT FOR SALE.
IN THE CLINIC
No incision and no sutures at placement. The procedure is designed to fit a standard interventional visit, using the visualization already on hand and an 18 gauge delivery needle, a size familiar from routine injections.
An injection, and the room you already have.
LIVING WITH IT
The electronics stay outside the body. The pulse generator is worn on the skin, attached to a patch, and comes off between sessions. Stimulation can be adjusted, paused, or stopped under clinician supervision at any point in the 30 days, without a procedure. When the course ends, the lead is grasped at the skin and drawn out.
Worn, not buried.
EXPERIENCE PNS™ SYSTEM
The System at a glance.
VERIFICATION AND VALIDATION
Where the testing stands.
The Experience PNS configuration is being evaluated through the verification and validation program supporting the 510(k) submission. Some of that work is complete and some is underway.
THE PLATFORM
Two configurations, one familiar placement method.
| Specification | Experience PNS™ | True PNS™ |
|---|---|---|
| Development stage | Clinical evaluation | Clinical evaluation |
| Duration | 30 days | Up to two years |
| At the skin | Proximal end of the lead remains accessible | No exit site |
| Power | External pulse generator, direct connection | External pulse generator, across the skin |
| Placement | 18 gauge needle, local anesthesia, clinic | 18 gauge needle, local anesthesia, clinic |
| Implanted electronics | None | None |
| Worn components | Generator, patch | Generator, patch |
| End of therapy | Lead removed at the end of the course | Designed for removal whenever chosen, within two years |
AFTER THE COURSE
Nothing left behind.
When the course ends, the lead is removed. What happens after is an open question rather than a scheduled one. True PNS would be one option, the chronic configuration, placed similarly. Choosing not to continue is equally available, and the course ends with nothing implanted.
Questions about Experience PNS?
We are glad to talk with clinicians about placement technique and target selection, and with investors and partners about the development path.