Research

The Biostat® System has been specifically designed to safely deliver BIOSTAT BIOLOGX® Fibrin Sealant into intervertebral discs with painful internal disc disruptions. Preclinical studies have demonstrated that the Biostat® Delivery Device allows for unhurried, controlled application of BIOSTAT BIOLOGX while improving the setting kinetics and flow characteristic of the material within the disc.1

CT image of an intervertebral disc after injection of radiopaque contrast solution (left) compared to a physical section of the same disc after treatment with the Biostat System (right) shows similar flow patterns of BIOSTAT BIOLOGX (labeled with methylene blue) and contrast within the disc.
12-week postprocedure
histological sections
Normal porcine disc
Injured and untreated porcine disc
Injured porcine disc treated with
the Biostat System
Pre-clinical studies of the Biostat System also provide strong evidence for the potential benefits of intradiscal application of BIOSTAT BIOLOGX. Researchers at the University of California San Francisco demonstrated that injured porcine discs which where supplemented with BIOSTAT BIOLOGX had significantly improved disc health after 12 weeks compared to injured discs which were left untreated. In addition, supplementation of injured discs with BIOSTAT BIOLOGX reduced the production of inflammatory factors associated with pain and increased the production of the growth factor TGF-β, an important protein involved in soft tissue healing.2 Additional pre-clinical studies demonstrated that disc cells exposed to BIOSTAT BIOLOGX produced lower levels of enzymes responsible for the degradation of disc tissues.3 These pre-clinical studies suggest that intradiscal application of BIOSTAT BIOLOGX with the Biostat System may enhance the repair of painful internal disc disruptions.


1 Spinal Restoration company data
2 Buser Z, Kuelling F, Liu J, et al. Fibrin injection stimulates early healing in the porcine model. Spine Journal 2009; 10S:105S.
3 Buser Z, Jane L, Thorne KJ, et al. Fibrin sealant modulates the inflammatory response in intervertebral disc cells. Unpublished manuscript.


 

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