TalisMann Neuromodulation System

The TalisMann Neuromodulation System is an implantable peripheral nerve stimulator for pain management in adults with severe intractable chronic pain of peripheral nerve origin, used as an adjunct to other therapies like medications. It delivers wireless electrical stimulation via an implanted lead to a target peripheral nerve to interrupt or modify pain signals, producing paresthesia (tingling/numbness) to reduce pain. The system is not intended for craniofacial pain.

The TalisMann uses wireless electrical coupling at 35 or 50 kHz to deliver current-controlled stimulation with burst frequencies of 1–200 Hz, burst duration of 100–500 microseconds, and maximum implant current of 26 mA. It reuses the previously cleared StimRouter Lead (3 cylindrical Pt-Ir electrodes, 1.2 mm diameter, 15 cm length) and incorporates a new titanium-housed Pulse Generator/Receiver, new implant tools, and updated Clinician Programmer Software. The external components include a rechargeable Lithium Polymer battery-powered E-EFC transmitter (5.7 × 3.7 × 1.2 cm, 28 g), hydrogel patch electrodes, optional mobile app (MAPP), and tablet-based Clinician Programmer.

Not stated in this summary. The document lists performance testing categories (EMC, electrical safety, usability, bench, animal, sterilization, biocompatibility) but does not cite specific ISO, IEC, or ASTM consensus standards.

The TalisMann is substantially equivalent because it targets the same peripheral nerves for the same indication (chronic pain management), uses the same cleared StimRouter Lead without modification, and maintains the same wireless energy delivery principle as the primary predicate (StimRouter K211965). Although the new Pulse Generator/Receiver uses different receiver materials (titanium and PEEK instead of Pt-Ir and silicone) and different transdermal frequency (35/50 kHz vs. StimRouter's undisclosed), nonclinical biocompatibility and materials testing confirmed safety equivalence. Electrical parameters (current amplitude, charge per burst, frequency range, waveform) are within or comparable to predicate ranges, and comprehensive bench, animal, and usability testing demonstrated no new safety or effectiveness concerns. The functional architecture—wireless powering of an implanted receiver coupled to a distal lead—is identical to the predicate design.