Executive summary

Stabilimax answers a real market need for dynamic stabilization of the lumbar spine

Spinal nonfusion technologies are quickly becoming the next evolutionary phase in the treatment of severe DDD.  The clear advantage of spinal nonfusion technologies are their abilities to restore and maintain relative motion and function while successfully treating the patient's pain symptoms. Pedicle screw based dynamic stabilization could be the most logical solution for most surgeons and patients who are seeking to preserve motion while still treating spinal instability and back pain. There is, in other words, a middle road between disc arthroplasty and spine fusion; a middle road that ultimately may be more consistently successful for patients and their surgeons. The Stabilimax® Dynamic Spine Stabilization System is an investigational non-fusion platform designed to support an injured or degenerated spine while preserving spine motion. Stabilimax has the potential to maintain spine motion and disc function, reduce pain and prevent or reduce the risk of adjacent level disc disease.

The 2009 global spinal non-fusion market generated approximately $900 million in sales; 22% OUS. Growth predicted to be to $3.3 billion in sales worldwide by 2015. Pedicle Based Dynamic Stabilization is third largest segment in space (behind Cervical Discs and Interspinous Spacers); ahead of facet replacements, with a CAGR of 26%.

Stabilimax design is based upon years of research and testing by leaders in spine biomechanics.

Technology incubated and conceived at Yale by Dr. Manohar Panjabi, and researched by Biomechanical Experts Dr. Lisa Ferrara - OrthoKinetic Technologies; Dr. Boyle Cheng - Allegheny-Singer Research Institute; and Dr. Avinash Patwardhan - Musculoskeletal Biomechanics Laboratory at Edward Hines Jr. VA Hospital. Pre clinical testing included Modified ASTM F1717 Testing – static & fatigue; Combination ending / elongation / compression test of spring construct (Spring Testing); Cable – fatigue testing; Modified ASTM F-2193 Testing - static & fatigue; 2 Generation (Peened) vs. 1 Gen (Grit); Wear testing (in serum and saline); Cadaver testing (destabilization model);Cadaver testing (pedicle screw forces); In vivo sheep model
(biocompatibility).

Stabilimax utilizes a proprietary combination of springs and articulating junctures to maintain desired range of motion and interpedicular travel

A true dynamic stabilization implant has an optimum stiffness profile, permits interpedicular travel, and thus maintains a near normal center of rotation. The combination of ROM and IPT allows both a quantitative and qualitative evaluation of spinal kinematics Indicated for patients receiving decompression surgery for the
treatment of clinically symptomatic central or lateral spinal stenosis, the device utilizes a patented Dual-Spring mechanism intended to provide an optimal stiffness profile and near-normal kinematics by permitting interpedicular travel. Incorporating a standard pedicle screw insertion technique, the pedicle screws feature patented ball and socket connections, allowing flexion and extension while minimizing the load applied at the
bone/screw interface. Internal Spring functions in unison with External Spring during extension and early flexion. External Spring works independently during late flexion. Internal cable constrains external spring during late flexion. The articulating juncture (ball and socket) allows device to be properly positioned; works in conjunction with the springs to allow motion, and directs load into the springs offloading the load on the
pedicle screws.

  • pre op

    pre op

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  • post op

    post op

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  • 24 month post op

    24 month post op

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For Additional Details:

Contact: Craig Corrance CEO
Cell – 407-923-0721
Email – ccorrance@rachiotek.com

 

 

** This product has not been cleared for use in the United States