Product Overview & Description
The StimRouter® Neuromodulation System is a clinically proven, permanent implantable PNS device designed for chronic pain management in adults with severe, intractable pain of peripheral nerve origin. Consisting of a single implanted lead, a discrete external transmitter, and a wireless handheld controller, StimRouter targets peripheral nerves directly to deliver long-term, non-opioid pain relief.
About This Item
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Clinically Proven Legacy Device: Proven long-term peripheral nerve stimulation technology trusted by thousands of patients worldwide.
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Minimally Invasive Single-Lead Implant: Uses a single implanted lead placed near the target nerve, powered transcutaneously by an external transmitter.
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Customizable Stimulation Programs: Allows patients and clinicians to select and adjust customized treatment programs using a wireless controller or app.
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Opioid-Sparing Therapy: Provides targeted relief for focal peripheral nerve pain without the risks of oral pain medications.
Indications & Usage
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Primary Indication: Pain management in adults with severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy.
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Exclusions: Not intended for pain management in the craniofacial region.
Summary of Safety & Risks
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Contraindications: Contraindicated in patients with demand cardiac pacemakers, ICDs, or other active active implants. Do not use in patients with active bleeding disorders, metallic implants, or cancerous lesions in the immediate implant zone.
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Adverse Reactions: Potential localized adverse effects include skin irritation and mild muscle aches at the stimulation site.
Product Specifications
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Brand Name: StimRouter®
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Manufacturer: Bioness Inc. / Bioventus LLC
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System Type: Permanent Implantable Neuromodulation System
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Regulatory Classification: Class IIb Active Implantable Medical Device (CE / UKCA Marked)
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Regulatory Notice: This product is strictly classed as a medical device (not a medicine).