Introducing the
Try Lead™
Investigational device. Availability subject to applicable regulatory approvals.
Fitting a Patient’s Needs
Chronic pain patients want drug-free treatment options that do not require surgery.
skin after placement shown in porcine model
The Injectrode is designed to allow patients to try out neuromodulation-based treatments at an earlier point in the pain patient treatment funnel than is currently common in clinical practice. This is achieved by simplifying the procedure to an injection and externalizing all active electrical components. By injecting only the lead with electrode portions as an injectable electrode, or Injectrode for short, the risk of post-placement scars is reduced and patient comfort is increased.
Try Lead & True Lead
The Injectrode System is designed to offer pain patients the option to try out neuromodulation for 90 days using the Injectrode as a Try Lead. If they like the therapy outcome, the future patient can elect to convert and retain the existing Injectrode instead of replacing it with a new lead, today’s suboptimal clinical practice in PNS pain.
We call this reclassification of the temporary Try Lead to the permanent True Lead the “Just Keep It” decision on day 90, thereby initiating the chronic use case. If the patient does not like the therapy, they may opt to have the Injectrode removed, currently via a small 3-5mm incision to access the Injectrode with forceps. The removal via forceps utilizes the unzipping of the Injectrode using the “Just Pull It” technique, to be followed by closure with steri-strips.
The following diagram illustrates this decision-making process
Try Lead
90 days, Temporary, Non-Committal
Patients will be provided with 10 patch electrodes that connect the EPG to the patient’s skin. These patch electrodes are designed for 2 to 4 days of use each. The 90-day Try Lead period is intended to provide the future patient with the chance to evaluate different stimulation parameters for optimal pain reduction. By the end of the Try Lead period, patients and physicians will be able to assess therapy outcomes and conclude whether or not to convert the Try Lead to the chronic stage True Lead.
True Lead
Design for Years to Come
Once confirmed as a tried and true solution by day 90, we envision the therapy to evolve to quarterly check-ins, potentially via remote / virtual visits: Verification of pain treatment efficacy, optimization of waveforms for optimal comfort and quality of care, and prescription of the next set of 90 days of patch electrodes (prescription only, consumables, 1 pack of 30 pieces). The Injectrode is designed as a long-term lead with MRI in mind, more information can be found here.
External patch electrodes are Rx Consumables, designed for 2 to 4 days of use. The initial package for the 90-day Try Lead period includes 10 patch electrodes. Once confirmed as chronic stage True Lead, sets of 30 patch electrodes for the quarterly use case will become available.
Future Developments:
Connecting IPGs & Receivers
Our vision is to offer patients options. Some may want to just continue with the True Lead long term, powering the Injectrode via our EPG coupled with external patch electrodes. Other patients may want to utilize an implanted signal generator. We have an adapter in pre-clinical development that is designed to connect an already placed Injectrode to either a battery-powered IPG or an inductively powered Receiver circuit. Research and development work is on the way.