Spinal Stabilization Technologies, LLC Logo are trademarks or registered trademarks of Spinal Stabilization Technologies, LLC PerQdisc™ Nucleus Replacement-CAUTION: Investigational Device. This device is not cleared by the FDA for distribution in the United States.

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Innovative Technology

Spinal Stabilization Technologies™ introduces a lesser invasive alternative treatment: The PerQdisc™ Nucleus Replacement System. A minimally invasive surgical option that replaces the physical space of the nucleus, recreates the physiologic motion, and redistributes the weight bearing forces in an anatomical fashion.

PerQdisc™

PerQdisc™ Nucleus Replacement System

The PerQdisc™ Disc Nucleus Replacement System is intended to replace the nucleus pulposus in skeletally mature patients at least 22 years of age with symptomatic single level degenerative disc disease (DDD) at levels L1/2, L2/3, L3/4, L4/5, or L5/S1.

 

The PerQdisc™ Implant (image 1) consists of a shaped membrane as an outer chamber with an additional internal chamber. Each chamber is independently inflatable. Once the device is placed inside of the prepared disc space, the inner chamber is filled with radiopaque contrast media to verify the position of the implant, the outer chamber of the implant is then filled with a polymer. The liquid polymer cures in situ within 10 minutes at body temperature. Once cured the delivery system is withdrawn.

 

The Spinal Stabilization Technologies PerQdisc™ is currently undergoing clinical trials and is not commercially available in any country.

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A 3D Animation of the PerQdisc™ Technology

PerQdisc™ Mechanism of Action

The PerQdisc™ (image 2) acts by replacing the physical space of the nucleus, restoring pressure integrity and subsequently allowing redistribution of weight bearing forces across the vertebral endplates allowing for shared loading with the annulus. As with healthy nucleus, the PerQdisc™ is comprised of an incompressible material which, when contained by the annulus provides 50% of the load bearing requirements of the motion segment.

Surgical Procedure

The PerQdisc™ is designed to support a lateral traspsoas, and retroperitoneal (i.e., anterolateral) surgical approach to access disc space. Access through the annulus can be achieved using the PerQdisc™ Access System (image 3). Once annular access is achieved, a total nucleus removal (TNR) is performed through the disc access using various tools. Most of the nucleus material should be removed to create an adequate cavity for the implant.

The Implant Delivery Device (image 4) is then inserted through the Access Cannula into the enucleated disc space. The pressure inflator plunger injects contrast into the inner chamber of the implant. This aids in visualization as well as provides real-time monitoring of fill pressure. The outer chamber of the implant is then filled under volume and pressure control with a curable, polymer containing barium sulfate. The polymer cures in situ within 10 minutes at body temperature. Once cured, the contrast media is removed from the inner chamber of the implant and the delivery system is withdrawn.