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Product

Lumbar Fusion

Anterior

  • AxiaLIF
  • AxiaLIF 2L+

Lumbar Fusion

Posterior

  • Vectre
  • Pedicle Screws

Biologics

  • Bi-Ostetic BVF
  • Overview
  • Technique
  • Device
  • Instrumentation

Lumbar Fusion - Anterior

AxiaLIF® 2L™

The Least Invasive Solution to L4-S1 Lumbar Fusion

The AxiaLIF 2L System includes surgical instruments for creating a safe and reproducible pre-sacral access route to the L4-S1 vertebral bodies. Using the same incision point and trajectory through the presacral space as AxiaLIF, the AxiaLIF 2L technique features instrumentation for standard of care fusion principles, distraction, and stabilization of the anterior lumbar column while mitigating the soft tissue trauma associated with traditional lumbar fusion through open surgical incisions.

Using AxiaLIF 2L, the lumbar spine is accessed through an axial channel in the sacrum. This atraumatic tissue plane alleviates the need for the surgeon to cut through supporting muscles and ligaments, thus reducing post-operative pain and the prospect of complications.

Advantages

  • Safe, reproducible, pre-sacral approach
  • Minimally invasive access
  • Soft-tissue sparing
  • Annulus remains intact
  • Patients released from hospital in as little as one day
  • Restoration of disc height
  • Immediate rigid segmental fixation and stability of L4-S1

This device is intended to be used in conjunction with posterior fixation.

Lumbar Fusion - Anterior

Technique

Access

Make 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. After using the 10mm dilator, leave cannula docked in the sacrum. Drill through sacrum to L5/S1 disc space using the 9mm Drill. Next, use the 12mm Dilator and leave that cannula docked in the sacrum. Use the larger 10.5mm Drill through sacrum to L5/S1 disc space.

Discectomy and Bone Grafting (L5/S1)

Use a series of radial cutters and tissue extractors to remove the L5/S1 disc. Next, insert bone graft into disc space.

Advance Working Channel

Advance the 12mm Dilator to the inferior endplate of L5. Then, drill through L5 with the 9mmm Drill.

Discectomy and Bone Grafting (L4/L5)

Use a series of radial cutters and tissue extractors to remove the L4/L5 disc. Insert Bone graft into disc space.

Measurement and Implant Delivery (L4/L5 Rod)

Measure for the AxiaLIF 2L L4/L5 Rod. Insert the tubular retractor. Place the AxiaLIF 2L L4/L5 Rod.

Measurement and Implant Delivery (S1 Rod)

Measure for AxiaLIF 2L S1 Rod. Insert the S1 Rod.

Closure

Flush and aspirate with anti-biotic as needed. Close the skin in routine fashion and apply a dressing to the access site.

Lumbar Fusion - Anterior

Device

The precision, strength and control surgeons need.

  • Titanium alloy construction
  • 2-rod design allows for multiple configurations to fit patient anatomy and surgical objectives
  • 2 rods combine to form strong, single-piece construct

L4/L5 Rod

  • Implanted in L4 and L5, spans the L4/L5 disc space
  • Achieves approximately 2-5mm of distraction
  • 50mm, 55mm, 60mm, 65mm sizes available

S1 Rod

  • Implanted in S1, spans the L5/S1 disc space
  • Threaded waist and tapered shaft to engage L4/L5 rod
  • Achieves approximately 2.5 mm distraction per turn
  • 25mm, 30mm, 35mm sizes available

AxiaLIF 2L L4/L5 Axial Rods

Available Lengths Thread Differential Threaded Length Approximate Distraction
(A) L4 Section Threaded Length (B) L5 Section Threaded Length
50mm 10 x 11 20mm 25mm 2mm
10 x 12 4mm
55mm 10 x 11 22.5mm 27.5mm 2mm
10 x 12 4mm
60mm 10 x 11 25mm 30mm 2.5mm
10 x 12 5mm
65mm 10 x 11 27.5mm 32.5mm 2.7mm
10 x 12 5.5mm

AxiaLIF 2L S1 Axial Rods

Available Lengths Thread Pitch (C) S1 Rod Threaded Length Approximate Distraction
25mm 2.5mm 25mm 2.5mm per turn
30mm 2.5mm 30mm 2.5mm per turn
35mm 2.5mm 35mm 2.5mm per turn

Lumbar Fusion - Anterior

Instrumentation

The TranS1 AxiaLIF 2L System is a multi-component system including titanium implantable devices as well as instrumentation made of biocompatible materials such as titanium alloy, stainless steel, and nitinol. Like the AxiaLIF system, the 2L system fits conveniently on a mayo stand, and its instruments follow the procedure sequentially from left to right.

System Highlights:

The AxiaLIF 2L system uses many of the same instruments as the AxiaLIF system. However, in order to dilate and drill into L4, as well as place a two-piece implant, several new instruments have been developed.

The 12mm cannula and 12mm Dilator allow larger dilation of the sacrum, in order to place the S1 Rod. The 12mm cannula features a strong outer J-hook system to hold the 12mm dilator firmly in place while it is advanced into the sacrum.

The 10.5mm Drill is a stainless steel twist drill that goes through S1 to allow the S1 Rod to have full thread engagement with a press fit in the sacrum.

The 7.5mm Dilator is used to dilate the L4 vertebral body. Through biomechanical testing, dilating instead of drilling can create a higher resistance to subsidence.



Instruments

TR1-1101 AxiaLIF 2L System Reusable Instrumentation Kit (non-sterile)
TR1-01 Slap Hammer
TR1-02 6mm Dilator
TR1-03 8mm Dilator
TR1-04 10mm Dilator
TR1-35 12mm Dilator
TR1-23 9mm Cannulated Drill
TR1-24 10.5mm Cannulated Drill
TR1-26 9mm 2-Level Drill
TR1-25 7.5mm 2-Level Drill
TR1-31 2-Level Rod Driver
TR1-22 3mm Hex Driver
TR1-38 Plug Driver Retention Wire
TR1-33 Two Level Instrument Rack
TR1-34 Autoclave Tray for Two Level Reusable Instrumentation Kit
TR1-27 30° 2-Level Exchange Bushing
TR1-28 30° 2-Level Exchange Cannula
TR1-29 45° 2-Level Exchange Bushing
TR1-30 45° 2-Level Exchange Cannula
TR1-1203 AxiaLIF 2L System Single Use Non-Sterile Instruments
TR1-2200 AxiaLIF System Single-Use Kit
TR1-2201 4 Pack-Sterile Tissue Extractors
TR1-2202 2 Pack-Sterile Tissue Extractors
TR1-2203 Sterile Fixation Wire

Implants

  L4/L5 Rod Dimensions
TR1-2314 50 - 10 X 11
TR1-2315 50 - 10 X 12
TR1-2316 55 - 10 X 11
TR1-2317 55 - 10 X 12
TR1-2318 60 - 10 X 11
TR1-2319 60 - 10 X 12
TR1-2350 65 - 10 X 11
TR1-2351 65 - 10 X 12
  S1 Rod Dimensions
TR1-2312 25mm
TR1-1313 30mm
TR1-2349 35mm

Images

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