
Biostat® Disc Augmentation System
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Spinal Restoration, Inc. has developed the Biostat® Disc Augmentation
System specifically for treating discogenic low back pain resulting from
Internal Disc Disruptions (IDD). The Biostat Disc Augmentation System
consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, biologic
tissue sealant, and the Biostat® Delivery Device, a proprietary
application system designed to deliver the biologic to the disc.
The procedure, which is called resorbable biologic disc augmentation, involves application of BIOSTAT BIOLOGX Fibrin Sealant into a disrupted disc to occlude the annular fissures and lay down a tissue repair matrix. Occluding the fissures helps prevent leakage of the nucleus pulposus into the outer one-third of the annulus fibrosus or onto the spinal nerve root. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate pain by sealing the painful disruptions, reducing inflammation, and enhancing tissue repair.
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Spinal Restoration’s solution
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Spinal Restoration is currently conducting an Investigational Device Exemption (IDE) pilot study of the Biostat® Disc Augmentation System. Results from the pilot study will be used to support an application for a larger IDE study to demonstrate the safety and efficacy of this new therapy. CAUTION: The Biostat Disc Augmentation System is an investigational device and is limited by federal law to investigational use only. |
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