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Duo™ Ti Expandable Interbody Fusion Procedure

The goals of the ideal lateral interbody fusion procedure are to:

  • Place a large anatomy conforming implant for spinal alignment, structural support, and rapid restoration of stability
  • Efficiently perform the procedure through the smallest access possible to avoid psoas trauma and reduce compression/stretching of the neural structures to minimize the risk of neurological deficits following surgery
  • Indirectly decompress the nerve root(s)
  • Provide a quality outcome

 

The Duo Ti Expandable Interbody Fusion Procedure combines Spineology’s proprietary mesh technology with porous titanium and an anatomy-conserving tubular retractor to meet these goals and provide:

  • Enhanced Recovery
  • Exceptional Efficiency
  • Proven Outcomes

 

Enhanced Recovery

Retraction With The Duo Ti Portal Tube Ends Where Traditional Retractors Begin

The Duo Ti implant expands in multiple planes and can reach up to 30 mm in width. The procedure requires minimal tissue dilation and a small portal tube for device insertion. This results in less trauma to the psoas muscle and a decrease in stretch and compression on the nerve root.

  • Reduced retraction requirements by up to 60%
  • A portal tube position further from the posterior neural elements
  • Neural elements and psoas muscle remain protected throughout the procedure

 

Approach Side Patient Pain/Weakness

Patients did not experience clinically meaningful new onset or increased thigh symptoms postoperatively, indicating that the reduced exposure requirements of the Duo Ti system mitigate procedural morbidity.1

 

Exceptional Efficiency

Access to the spine with the Duo Ti system is accomplished with simple dilation and placement of a spine mounted Portal Tube. This creates a surgical platform that:

  • Is quickly installed
  • Eliminates the tissue creep common with retractor blades
  • Is extremely stable to prevent migration
  • Guides instrument trajectory
  • Enhanced radiographic visualization of anatomy aids procedural orientation

 

All which lead to a very efficient procedure which limits overall retractor time to mitigate retraction time related neurologic deficit.

 

Final Portal Tube placement with Fixation Pin secures Portal Tube to the spine.

 

Proven Outcomes

Spineology’s RaDical Study was conducted to assess short-term and long-term outcomes in patients treated with the Duo System. This prospective, multi-site evaluation of 200 patients is Institutional Review Board (IRB)-approved and captures both subjective and objective patient data in a real-world, adult population. To view the latest data from the RaDical Post-Market Study, click here.

The RaDical Study has demonstrated exceptional long-term fusion, pain, and functional outcomes.  Multi-plane expansion enables the use of a very small access portal which resulted in little to no approach side discomfort following the procedure, an issue known to be common with traditional monolithic devices.

 

Fusion

Note: The above 12-month post-op sagittal and coronal CT imagery incudes Spineology's 12 mm wide Duo PEEK implant.

98% (98/100) of patients in the RaDical post-market study demonstrated fusion on CT scans taken at their 12-month follow-up, as evaluated by two independent radiologists.1

 

Low Back and Leg Pain

Patients demonstrated clinically meaningful reductions in low back and leg pain by six weeks post-op.1

 

Back Function

Patients demonstrated clinically meaningful improvement in low back function shortly after surgery with continued improvement over time.1

 

References:

[1] Data on File. Spineology Inc.