Product Overview & Description
The TalisMann® Neuromodulation System is a next-generation permanent Peripheral Nerve Stimulation (PNS) platform designed for targeted chronic pain management without drug dependency. Combining an Implanted Pulse Generator (IPG) with patented electric field conduction technology, TalisMann delivers consistent, high-peak-current electrical stimulation directly to peripheral nerves at the pain source.
Engineered specifically for peripheral nerve anatomy, TalisMann features the smallest and lightest external wearable unit on the market, allowing patients to easily adjust their stimulation levels via an external wearable or smartphone app.
About This Item
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Next-Gen Permanent PNS: Combines an implanted pulse generator (IPG) with electric field conduction technology for powerful chronic pain relief.
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Purpose-Built Design: Optimized specifically for peripheral nerves with the industry's highest peak current capability.
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Ultra-Light Wearable: Features the smallest, lightest external wearable unit for maximum patient comfort and daily compliance.
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Patient-Controlled Relief: Patients can easily tune and adjust stimulation intensity using an external skin-worn controller or mobile app.
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Non-Drug Alternative: Targets intractable chronic pain at the anatomical source without reliance on oral opioids or systemic pain medications.
Indications & Usage
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Primary Indication: Indicated for 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 to treat pain in the craniofacial region.
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Administration: Implanted by a qualified pain management specialist or neurosurgeon in a hospital, ambulatory surgical center (ASC), or outpatient setting.
Summary of Safety & Risks
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Contraindications: Do not use in patients with demand cardiac pacemakers, ICDs, or other active implanted devices. Contraindicated in patients with unmanageable bleeding disorders, metallic implants, or cancerous lesions at the implant site.
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Adverse Reactions: Potential risks include localized skin irritation or muscle aches in the area of stimulation. Safety during pregnancy has not been established.
Product Specifications
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Brand Name: TalisMann®
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Manufacturer: Bioness Inc. / Bioventus LLC
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System Type: Permanent Peripheral Nerve Stimulation (PNS) IPG System
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Technology: Electric Field Conduction Technology
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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).