Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
StimRouter System · 1 trial · 1 indication
Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.
| Arm | Type | Description |
|---|---|---|
| StimRouter (SR) for CTS | EXPERIMENTAL | Percutaneous implantation of StimRouter System |
| Name | Type | Description |
|---|---|---|
| StimRouter System | DEVICE | Implanted with StimRouter System receive 6 hours (or less if not tolerated by the Subject)of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming) |
Inclusion Criteria: * 18 years of age or older * Chronic peripheral pain persisting for greater than or equal to 3 months diagnosed previously as a mononeuropathy of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS) * Average chronic pain level greater than or equal to 5/10 \...
The StimRouter System is used for unilateral Carpal Tunnel Syndrome. It is an investigational device being studied as a peripheral nerve stimulation treatment for this condition. The system is currently in Phase 1 clinical development and is not yet approved by the FDA.
The StimRouter System is being developed by Bioventus Inc., a company traded on the NASDAQ under the ticker symbol BVS. The company is conducting clinical research to evaluate the device for the treatment of unilateral Carpal Tunnel Syndrome.
The StimRouter System is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA. One Phase 1 study has been completed to evaluate its safety and performance in patients with unilateral Carpal Tunnel Syndrome.
The StimRouter System has one completed clinical trial, NCT00665132, titled 'Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves.' This Phase 1 study enrolled 10 participants with unilateral Carpal Tunnel Syndrome in the United States and has been completed.
The StimRouter System is a specific peripheral nerve stimulation device developed by Bioventus Inc. for unilateral Carpal Tunnel Syndrome. It is not known to be the same as any other named device, and no alternative names have been associated with it in clinical trial records.