The randomized, open label, parallel assignment, safety/efficacy study is ongoing, but not recruiting participants. The trial is estimated to enroll 500 participants.
In-Space is a interspinous spacer device which uses the process of interspinous distraction. Using a percutaneous approach, requiring a 1.5 cm incision for the insertion of a series of tools that use blunt dilation rather than cutting to get past spine muscles and position the implant. To position the insertion sleeve that will guide the implant for placement between the vertebrae, the intra-spinous ligament is pierced but significantly, the supra-spinous ligament is not touched. This device enables treatment of lumbar stenosis.
