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NEURO
Development of SYNTHECEL Dura Repair SYNTHECEL was developed as a superior dural substitute, with the aim to eliminate or reduce many of the adverse events mentioned above. SYNTHECEL Dura Repair is an implant based on biosynthesized cellulose technology. Cellulose pellicles of specified weight and cellulose content are produced by the bacterium Glucoacetobacter xylinus when propagated in nutritive culture media.
Fig 3 Investigational device exemption (IDE) intraoperative image showing a dural repair using SYNTHECEL Dura Repair (courtesy of Barrow Neurosurgical Associates).
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Fig 4a–b Demonstrating the product’s strength (a) and sutureability (b).
Comprised of nonwoven, interconnected cellulose fibers, SYNTHECEL has excellent tensile strength and functions as a mechanical layer to protect and repair dural defects while preventing CSF leakage (Fig 3). SYNTHECEL is immunologically inert, allows healing without adhesion formation, and avoids the complications inherent in the use of autologous tissue in duraplasty. SYNTHECEL is nonanimal derived, meaning there is no risk of transmissible diseases. Clinical performance of SYNTHECEL Dura Repair Clinical studies have shown that SYNTHECEL Dura Repair is not inferior to other commercially available dural replacement products in terms of surgical site infection, wound healing assessment, or radiologic endpoints (absence of pseudomeningocele and CSF fistula) [1]. Furthermore, SYNTHECEL was shown to be superior in terms of product strength, sutureability and seal quality (Fig 4). Indeed, a prospective randomized controlled study found SYNTHECEL to exhibit superior strength and sutureability (Figs 5–6) [1]. In terms of surgical handling, SYNTHECEL is similar in thickness to human dura and conforms easily to the brain. References 1 Rosen CL. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov; 69(5):1093–1103; discussion 1103–1104.
Fig 5 SYNTHECEL Dura Repair exhibited superior device strength compared to a control group, in an assessment of device handling characteristics [1].
Fig 6 The product also exhibited superior seal quality compared to the control group [1].
AOTK SYSTEM INNOVATIONS 2015