Product Overview & Description
The StimTrial™ System is a temporary, minimally invasive trial peripheral nerve stimulation system engineered to evaluate patient candidacy and efficacy before committing to a permanent PNS implant. Suitable for quick, minimally invasive placement in hospital, ASC, or clinical office settings, StimTrial allows physicians and patients to assess targeted pain reduction over an evaluation period of up to 30 days.
About This Item
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Minimally Invasive Trial Platform: Purpose-built for temporary evaluation prior to permanent PNS system implantation (such as TalisMann or StimRouter).
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Versatile Placement Settings: Designed for convenient implantation in hospital, Ambulatory Surgical Center (ASC), or outpatient office environments.
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Up to 30-Day Evaluation: Provides up to 30 days of continuous stimulation to demonstrate clinical efficacy and functional improvement.
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Patient-Friendly Controls: Includes a lightweight external wearable transmitter with adjustable settings via wearable or mobile app.
Indications & Usage
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Primary Indication: Indicated for trial stimulation (no longer than 30 days) to determine treatment efficacy before recommending permanent PNS implant placement for adults with severe, intractable chronic pain of peripheral nerve origin.
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Exclusions: Not intended to treat pain in the craniofacial region.
Summary of Safety & Risks
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Contraindications: Do not use in patients with implanted cardiac pacemakers, ICDs, active implants, or unmanageable bleeding disorders. Contraindicated near metallic implants or localized cancerous lesions.
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Adverse Reactions: May cause transient skin irritation or mild localized muscle aches in the stimulation zone.
Product Specifications
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Brand Name: StimTrial™
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Manufacturer: Bioventus LLC
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System Type: Temporary Trial Peripheral Nerve Stimulation System (Up to 30 days)
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Regulatory Classification: Class IIa Medical Device (CE / UKCA Marked)
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Regulatory Notice: This product is strictly classed as a medical device (not a medicine).