Nerivio, a wireless neuromodulation wearable from Theranica for drug-free acute treatment of migraine, features an electronic housing moulded in a Thermolast M custom-coloured medical-grade thermoplastic elastomer compound from Kraiburg TPE.
The device has passed clinical testing, is FDA-authorised and conforms to all applicable IEC/EN 60601 standards for medical devices, and nerve stimulators. The TPE material provides ISO 10993 certified biocompatibility and is supplied in line with new VDI 2017 guidelines.
Non-pharmacological treatment of migraine and other pain conditions has become a challenge, not just in remote areas without ready access to outpatient care facilities, but also under the constraints of social distancing amid the current COVID-19 pandemic. Theranica has developed a neuromodulation device – Nerivio – aimed to address both issues with a convenient wearable solution for personalised, app-controlled acute treatment of migraine. The electroceutical device is worn on the arm and uses electronic pulses for inducing a drug-free pain inhibition mechanism. The user-friendly app is available for both Android and iOS smartphones and includes a migraine diary that can be shared with healthcare professionals, for better managing this disabling disease.
Alon Ironi, president & CEO of Theranica, said: “For the outer layer of the Nerivio, we tested a variety of different biocompatible materials to find the best combination of soft feel, certified dermatological tolerance, processability and surface quality. Furthermore, the compound had to provide long-term adhesion to double-sided sealing tape, without delamination.”
In close cooperation with AiT Chemicals, a supplier of polymers and Kraiburg TPE’s distributor in Israel, Theranica selected a Thermolast M medical-grade thermoplastic elastomer (TPE). It delivers a surface ‘as moulded’, with durable abrasion resistance to the securing armband and strap of the device. It is biocompatible and meets cytotoxicity requirements, which have been certified respectively to ISO 10993-10 and ISO 10993-5 standards. The compound is pre-coloured ex works to match the stylish grey surface texture of the armband according to customer requirements. Also, many of Kraiburg TPE’s portfolio compounds are documented in FDA Drug Master Files.
Oliver Kuge, advisor for medical products at Kraiburg TPE, said: “Thanks to our long-standing partnership with AiT Chemicals and our early inclusion in this application project, we were able to supply a custom-tailored TPE that meets all the specifications and requirements of Theranica, from ease of processing to biocompatibility and colour.”
Following comprehensive clinical clearance, the Nerivio device received a De Novo approval from the U.S. Food and Drug Administration (FDA) for clinical use in May 2019. The FDA classified the wearable as a trunk and limb electrical stimulator to treat headache. It conforms to all applicable IEC/EN 60601 standards for the safety and electromagnetic compatibility of medical electrical equipment, nerve, and muscle stimulators.
