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Investigational device - device limited by FDA for investigational use.

Lumbar Intervertebral Disk Stabilization (LIDS) is a procedure developed by Dr. Madhavan Pisharodi, MD. This is an interbody fusion technique wherein the disk space is stabilized primarily by a biconvex device (Pisharodi Device) followed by stabilization attained through fusion.

Lids AssemblyPisharodi Device is an investigational device. The technique was approved by FDA for a feasibility study involving 25 patients followed by a multi-center randomized clinical trial involving 340 patients using another disk device ascontrol. The device is a solid three-piece Titanium (ASTM F136) implant system. It has a biconvex core piece, an end cap that glides on to it and a screw to securethe two pieces together.

Implantation of LIDS device is done posteriorly after simple diskectomy on one side. The biconvex piece is introduced horizontally and rotated 90 degrees inside the disk space. The end cap is glided along the sides of the biconvex piece and the screw applied to secure the two pieces. Usually unilateral implantation is adequate. The remaining disk space is filled completely with autograft.

So far 96 patients have been implanted with LIDS device. The patients have to undergo follow-up evaluations at 3, 6, 12, and 24 months after the surgery.

Investigational device - device limited by FDA for investigational use.