Alphatec Releases Solutions for TLIF Approach

Alphatec Holdings Inc., a medical device company dedicated to revolutionizing the approach to spine surgery, has released two new solutions designed to elevate the ATEC transforaminal lumbar interbody fusion (TLIF) clinical experience. The Sigma Access System and the InVictus Modular Pedicle Screw are novel technologies that fully integrate with the SafeOp Neural InformatiX system, the SingleStep implant delivery system and IdentiTi TLIF implants, to enable a comprehensive, intelligently designed TLIF approach.
 
“These new product releases further our commitment to architect complete surgical procedures, the core competency of the ATEC Organic Innovation Machine,” said Pat Miles, chairman and CEO. “The Sigma TLIF Access System and InVictus Modular Screw solutions are not makeovers of existing products. These technologies have been crafted from the ground up to better meet the specific needs of the TLIF approach and effect a more predictable, less disruptive technique. These products are just two examples of the approach-based innovation that we are releasing in 2020. ATEC continues to move spine surgery forward, compelling surgeon adoption with distinct innovation that enhances intraoperative confidence and improves surgical outcomes.”
 
Developed to address the unique requirements of the TLIF technique, the Sigma TLIF Access System is ATEC’s first pedicle-based access system, elegantly engineered to provide direct visualization of key anatomical landmarks and improve the reproducibility of the MIS TLIF approach.  The Sigma TLIF Retractor incorporates a fiber optic light source to improve illumination and an integrated steerable jamshidi for unprecedented shank navigability.
 
Samuel A. Joseph, Jr., M.D., orthopedic spine surgeon and founder of the Joseph Spine Institute in Tampa Bay, Fla., commented, “The Sigma TLIF Retractor’s intuitive features offer unique versatility. Independent cranial/caudal opening or optional disc space distraction for collapsed disc spaces were astutely built into the access system.  I can address unilateral pathology, or, if needed in complex cases, address bi-lateral symptoms through simultaneous bi-lateral approaches.”
 
Engineered to enhance the adaptability of the InVictus spinal fixation platform with the power of modularity, the InVictus Modular Pedicle Shank attaches directly to the Sigma TLIF Access System. InVictus Modular incorporates visual, tactile, and audible confirmation of tulip attachment to instill intraoperative confidence. Integrated seamlessly with Single Step technology, InVictus Modular extends the dependability and predictability of InVictus MIS fixation and can obviate the need for guide wires, which are commonly associated with surgical complications.
 
Dr. Andrew Roeser, M.D., a neurosurgeon at Houston Methodist Hospital in Texas, added, “The seamless integration of InVictus SingleStep & MIS MOD to the Sigma TLIF system make for a highly efficient and reproducible procedure. By anchoring the retractor blades to the spine, I am able to visualize the same exposure every time, regardless of patient size. That is paramount to consistent clinical outcomes, and incredibly helpful when teaching residents in my O.R.  Although there is soft tissue covering the anatomy, each time I open the retractor, I can see the headless screws and know exactly the location of pertinent anatomy.”
 
Key Features of the Sigma TLIF Access System 

• Facilitates access to collapsed disc space through vertebral body distraction
• Improves illumination with integrated fiber optic light source
• Provides direct visualization of facet, pars, and lamina with modular shank and blade
• Enables customized exposure with independent cranial and caudal retraction
• Supports differing patient pathology with surgeon-guided medial blade
• Streamlines assembly with quick-connect engagement

• Leverages dependable helical flange tulip technology to reduce cross-thread potential and help eliminate tulip splay
• Boasts modular tulip interconnection strength 4.5x greater than the average pull-out strength of pedicle screws
• Adapts intraoperatively to surgical techniques with robust instruments and customizable modular implants designed to accept multiple rod diameters and materials 
• Advances the standard of Modular Fixation with a guidewire-less SingleStepTM technique to deliver modular shank and SIGMA blade with one instrument pass
• Integrates with ATEC’s neural informatix system, SafeOp, to predictability provide surgeons with real-time, actionable information to detect and monitor the health of nerves at risk during posterior fixation
• Instills confidence with audible, tactile and visual confirmation of reproducible Tulip to Shank attachment