The IDSD - What is it, and how does it work?
The IDSD is manufactured by Intralink-Spine in its ISO-13485:2016 certified manufacturing facility in Lexington, Kentucky. To administer the device, the IDSD vial components are combined and injected into the spinal disc. IDSD is delivered as a liquid and self-polymerizes to form solid mechanically-functioning implant chains or "nano-tethers". The IDSD simultaneously disperses uniformly through the porous extracellular matrix of the intervertebral disc’s annulus fibrosus region, and attaches the chain ends to the peripheral fibrils of the disc annulus’ extracellular matrix. Genipin molecules begin to self-polymerize in seconds (prior to injection), with the majority of dispersal, self-polymerization, and attachment complete within 10 minutes, while the remaining unattached polymers diffuse through and attach to the dense but porous matrix upon contact until all of the genipin chains are attached to the matrix. Once the local dispersal, self-polymerization, and attachment are complete, the IDSD is inert and physically secures the targeted disc to inhibit unconstrained excessive motions and stabilize the spinal joint.
Schematic of peripheral disc annulus collagen molecules (2 blue and 1 red helix) after attachment of genipin “nano-tethers” (self-polymerized oligomers of genipin; green bands)