Product

Lumbar Fusion

Anterior

• AxiaLIF
• AxiaLIF 2L
• AxiaLIF 360

Motion Preservation

Anterior

• PNR

Motion Preservation - Anterior

PNR

Disc Arthroplasty

We are focused on developing novel minimally invasive implants that will utilize and leverage our TranS1 approach to the lumbar spine. We currently have a disc arthroplasty (PNR) device in development that is intended to be used as a surgical therapy earlier in the progression of degenerative disc disease than fusion, as it is designed to preserve motion in the lumbar spine while providing stabilization. This is achieved by removing the diseased nucleus and replacing it with a prosthetic nucleus.

Our modular product designs enable physicians to revise the implant to address disease progression. We believe these features may encourage more patients and physicians to elect surgical intervention, as well as encourage them to elect surgical intervention earlier in the progression of their disease.

The PNR implant's unique design accommodates motion and translation within the normal physiologic range. It preserves annulus, endplates, anterior and posterior longitudinal ligaments, thereby preserving all future surgical options. It mitigates limitations and complications associated with an anterior approach. The implant accommodates axial compressive loads (cushioning or dampening capacity).

Lumbar Fusion - Anterior

Technique

Access

Make an incision lateral to the tip of the coccyx. Advance the dissecting tool to the docking point on Sacrum.

Establish Working Channel

Use a series of dilators in sacrum. With last dilator, leave the cannula docked in the sacrum. Then, drill through sacrum to L5/S1 disk space.

Discectomy

Use radial cutters and tissue extractors to remove disc.

Drilling

Insert the 2-Level 9.0mm Drill into the 12mm Dilator Sheath and rotate the handle clockwise to drill two thirds of the way into the L5 vertebral body.

Anchor and Plug Insertion

Insert Distal Plug using Distal Plug Inserter shown in Figure 25 by twisting it into the Distal Anchor after passing it through the Proximal Anchor Retainer.

Nucleus Implant Insertion

Under fluoroscopic guidance, deliver the Disc Arthroplasty Material into the Containment Membrane within the disc space. Allow the Disc Arthroplasty Material to cure for 10 minutes.

Lumbar Fusion - Anterior

Device

The TranS1 PNR is an implant that imitates the movement of a nucleus, thus restoring disc motion. The titanium implants act as anchor for the membrane that is filled and acts as the artificial nucleus.

Anchors

Plugs

Lumbar Fusion - Anterior

Instrumentation

The TranS1 PNR System is a multi-component system including titanium implantable components as well as instrumentation made of biocompatible materials such as stainless steel and Nitinol. This system fits conveniently on a mayo stand, and its instruments follow the procedure sequentially from left to right.

Membrane Inserter

The membrane inserter is a cannulated device that has two major functions:

1. Distract the two adjacent vertebrae restoring proper disc height
2. Insert the disc arthroplasty material into the prepared nucleus cavity.

Once the PNR material has been properly inserted, the membrane inserter is then removed, leaving behind the nucleus material and giving individuals normal disc motion.

Instruments

Implants