First FDA Cleared Thin Film Electrode for Intracranial Recording and Monitoring of Brain Activity – Device Testing and Initial Clinical Use
Abstract number :
Submission category :
4. Clinical Epilepsy / 4B. Clinical Diagnosis
Submission ID :
Presentation date :
12/5/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Aura Kullmann, PhD - NeuroOne; Steve Mertens, MS – Chief Technology Officer, NeuroOne; Mark Christianson, BS – Co-Founder, NeuroOne; Dave Rosa, MS – Chief operating officer, NeuroOne; Camilo Diaz Botia, PhD – Director of electrode development, NeuroOne
Rationale: Subdural strip and grid (SDG) electrodes are routinely used for pre-surgical evaluation of patients with drug resistant epilepsy (DRE). Although these electrodes have been in the US market since their first FDA clearance in 1985, their fabrication, materials and properties have hardly changed. They are made of silicone, are thick ( >0.5mm), manufactured by hand, and do not optimally conform to brain convolutions. Here we describe a battery of electrochemical, electrical and biocompatibility tests that led to the first FDA cleared thin film electrode (EvoTM Cortical) for use in clinical practice. We also present preliminary post-market user feedback data from initial clinical use.
Methods: Thin film electrode (0.08mm) arrays were manufactured from polyimide with platinum contacts (multiple configurations, 3 mm contact diameter, spaced 10 mm apart). Electrochemical and electrical testing include electrolyte interface impedance, cyclic voltammetry and voltage transients, according to the International Electrotechnical Commission (IEC) 60601 for proving device safety and performance. Biocompatibility was tested using in vitro and in vivo standard methods according to International Organization for Standardization (ISO) 10993. Post-market data were collected employing a user feedback questionnaire using a rating scale (1 to 5, with 5 being the highest).
Results: Thin film electrodes passed all electrochemical, electrical and biocompatibility testing required for FDA clearance (obtained Nov 2019). Electrodes (n=21) were used in clinical practice in the epilepsy monitoring units (EMU) and for intraoperative monitoring (IOM) for recording brain activity in (a) DRE patients undergoing evaluation for potential surgical resection, and (b) patients undergoing tumor resection. Users (neurosurgeons; n=7) provided ratings between 4 and 5 regarding the properties (thickness, flexibility, weight), features (ease of placement, conformability to the brain areas) and performance (qualitative signal recording quality) of the electrodes during surgical implantation.
Conclusions: This is the first thin film electrode technology FDA cleared for use in clinical practice. The properties of these thin, flexible polyimide electrode arrays overcome many limitations of the existing technology. Initial clinical use indicated that the technology is feasible for surgical implantation with greater flexibility compared to silicone based cortical electrodes. This technology has the potential to minimize invasiveness of subdural recordings and improve surgical outcomes.
"Caution: Federal law restricts this device to sale by or on the order of a physician"
Funding: Please list any funding that was received in support of this abstract.: Funding: NeuroOne Medical Technology Corporation.