Research Project
2460572
The goal of this project is to develop a set of endoscopic surgical tools, designed specifically for neurosurgery. The instruments will include both curved and malleable versions, allowing them to be placed in "blind spots", where - without excessive retraction, neurosurgeons cannot normally see. Visualization will be provided by a removable endoscope. These instruments will allow application of "minimally-invasive surgical" techniques to neurosurgery. For example, they may help reduce morbidity in 45,000 spinal surgery procedures annually in the USA alone. A key goal is to develop reusable endoscopes to be used with the surgical instruments. The availability of reusable endoscopes, as compared to single-use models, will keep the cost of the equipment low, and will also reduce medical waste. The study methodology will include a clinical trial. Extensive testing, using industry-standard techniques, will be used to assure that an adequate sterilization assurance level is reached. The project will generate data concerning the proposed devices' safety and effectiveness, and these data will be used in a product clearance submission to the Food and Drug Administration following FDA clearance, Clarus will be prepared to commercialize these devices. PROPOSED COMMERCIAL APPLICATION: Suitable for 15% of lumbar spine discectomies--i.e. 45,000 procedures annually; many intracranial tumors (e.g. craniopharyngioma).
