Phase II year
2018
(last award dollars: 2019)
Phase II Amount
$1,497,984
This Small Business Innovation Research Phase II project supports the development of a novel bioabsorbable surgical clip and applier for rapid closure of the dura mater in open and minimally invasive spine surgery. The dura mater is the protective membrane that covers the brain and spinal cord and contains cerebrospinal fluid (CSF). Openings in the dura (durotomy) can result in CSF leakage which, if not repaired, can cause potentially fatal complications including spinal headaches, pseudomeningocele, and meningitis. Currently, the dura is closed using fine suture in a difficult and time-consuming process requiring an average of 20 minutes of additional operating room time. Durotomies occur in approximately 14% of spinal surgeries and with 1.7M spinal surgeries, closure of incidental durotomies costs the healthcare system an estimated $428M each year in time alone. In Phase I, a novel dural clip was developed and underwent proof-of-concept and feasibility bench testing. Phase II research will seek to complete development of the dural clip and applier and to perform preclinical testing of the dural clip system. These objectives will be accomplished through the following proposed specific aims: 1) Complete development of the dural clip applier and cartridge system; 2) Determine the effect of e-beam radiation sterilization on clip mechanical properties and aging; 3) Characterize the absorption and biocompatibility of the dural clip device in an in vivo rat model; and 4) Assess dural clip function in a large animal functional pilot study. NeuraMedica will work with a regulatory consultant and the FDA to ensure each step meets regulatory requirements. Successful completion of this NIH Phase II project will allow for the translation of our research findings to a commercially available device that will improve durotomy repair.
