Medical Device Classification : Class D
Technology Readiness Level : TRL4
Intended end use : Epilepsy is the third most commonly diagnosed neurological disorder. Epileptic seizures are the result of excessive and abnormal nerve cell activity in certain regions of the brain. The surgical removal of the epileptogenic area of the brain is the most effective treatment available for epilepsy. Intracranial electrodes help localize the epileptogenic zone accurately and precisely by electrophysiological monitoring.
Product description : The device employs platinum/stainless steel electrodes with MP 35/Stainless steel connection wires embedded between two flaps of silicone rubber. The connections terminate at the distal end, which is compatible with Video EEG systems.
Novelty :
Patent- Granted
Patent no : 527030 DOG: 15/03/2024 -process of thin flexible electrode encapsulation for cortical electrodes
Patent Filed
Application no: 201841007029 DOF: 24/02/2018-a Mold for cortical electrode fabrication
Design registration
Thermal curing mold pattern assembly DR no: 368048-001
Current Development stage/ Evaluations done :Proof of Concept completed. Limited animal trials were done for safety.
Industry responsibility : Scaling up and Clinical trials
Deliverables from Institute :
Device master file
MEM and PEM
Test reports
Training on Mold making, Fabrication of the electrodes and test setups.