The document discusses the ASPEN spinous process fixation system as an alternative to pedicle screws for spinal fixation and fusion. It provides indications for use, describes reduced muscle dissection compared to pedicle screws, and reviews clinical applications. Biomechanical testing results and clinical studies demonstrate fusion rates comparable to pedicle screws with quicker patient recovery. The ASPEN system offers a less invasive option than pedicle screws for certain patients.

1. Overview

2. WHAT IS THE ASPENTM
MIS FUSION SYSTEM?

3. 3LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
FUSION vs. NON-FUSION
The ASPEN device is not
an “interspinous spacer”

4. 4LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
FUSION vs. NON-FUSION
The ASPEN device is a less invasive
option to pedicle screws for
fixation/fusion

5. 5LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
INDICATIONS FOR USE:
KEY POINTS
The LANX Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-
pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature
patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc
disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history
and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis;
deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed
previous fusion.*
The ASPEN system is intended to be used to help provide immobilization and stabilization of spinal
segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The system is intended for use with autograft or allograft.
The ASPEN device is a posterior, non-pedicle supplemental fixation device, intended for use at a single
level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for
the purpose of achieving supplemental fusion in the following conditions:
• degenerative disc disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation);
• and/or tumor.
The ASPEN device is intended for use with bone graft material, not intended for stand-alone use.
* Applies to pedicle screws

6. 6LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
REDUCED MUSCLE DISSECTION
• Pedicle screws require significant lateral dissection
• More muscle and soft tissue preservation with the
ASPEN system
• Reduces risks of neural and vascular injury
vs.

7. CLINICAL APPLICATIONS

8. 8LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
INTERBODY FUSION
RIGID POSTERIOR FIXATION
ASPEN Implant + Lateral LIF
Simple posterior procedure to provide
stabilization with a lateral cage. Save
time by not repositioning the patient
from lateral decubitis position.
ASPEN Implant + ALIF
With an ALIF cage, ASPEN implant
provides equivalent biomechanical
stability to bilateral pedicle screws.
1
ASPEN Implant + T/PLIF
May be preformed through a single,
midline MIS incision May be combined
with unilateral screws for additional
stiffness.
1. Karahalios DG, et al. Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion.
J Neurosurg Spine. 2010. 12(4): 372-380.

9. 9LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
THE ASPEN DEVICE
“BRIDGES THE GAP” WHEN…
…a decompression ALONE is
inadequate to treat the condition.
Instability is a concern; (e.g., iatrogenic
or pre-existing instability) therefore, a
fusion is indicated. However…
…a pedicle screw-based FUSION is
too much. Perhaps because (a) the
patient is older or has multiple
comorbidities and wouldn’t tolerate the
“big” pedicle screw procedure and/or
(b) pedicle screws are unnecessarily
traumatic (e.g., synovial cyst).

10. 10LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
“BRIDGING THE GAP”
LAMINAR ONLAY
PACK FACETS
IN THE BARREL
POSTERIOR TO BARREL
(if SSL removed)
COMMON DIAGNOSES COMMON PROCEDURE COMMON SCENARIO
Low grade spondylolisthesis
and/or
Degenerative disc disease,
including the following potential
conditions resulting from DDD:
• Lumbar spinal stenosis with
radiating pain
• Synovial cysts
• Recurrent disc herniation
1. Direct decompression
• Hemilaminotomy
• Conservative bilateral
laminotomy
2. Decortication and
bone grafting
• Facet joint
• Laminar onlay
• Within the barrel
• Posterior to the barrel
3. Aspen device implantation
Possibly with some indirect
decompression from the barrel,
but don’t over distract
Patient
• Older
• Multiple comorbidities
• Low grade spondy
• Mild instability
Solution
• Direct decompression
• Posterior stabilization
and fusion with the
ASPEN device

11. PROVEN BIOMECHANICAL
& CLINICAL SUCCESS

12. 12LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
BIOMECHANICAL
TESTING RESULTS
1. Karahalios DG, et al. Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. J Neurosurg Spine.
April 2010. 12(4): 372-380.
2. Kaibara, et al. Biomechanics of a lumbar interspinous anchor with transforaminal lumbar interbody fusion. World Neurosurgery.
May 2010. 7 3(5): 572–577.

13. 13LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
1. Amir Vokshoor, et al. Radiographic Evaluation of Fusion and Clinical Outcomes in
Minimally Invasive Lumbar Surgery using Spinous Process Fixation. Data presented
at the World Neurosurgical Society, 2012 Annual Meeting, September 2012.
“…achieve fusion in up to 92% of patients with a
less invasive approach than traditional fusion.” 1
CLINICAL STUDIES
ROBUST FUSION RATES

14. 14LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
IMPROVED PERI-OPERATIVE MEASURE
COMPARED TO PEDICLE SCREWS
A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the ASPEN™ Spinous Process
System for use in Anterior Lumbar Interbody Fusion (ALIF)* ClinicalTrials.gov Identifier: NCT01016314.
Interim results. Data on File at LANX, Inc.

15. 15LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
ASPEN DEVICE VS. PEDICLE SCREWS:
DEGENERATIVE SPONDYLOLISTHESIS OUTCOMES
•ODI and SF-36 scores indicated that the ASPEN device group
recovered more quickly than the pedicle screw group, although
long term outcomes were similar.
•By 6 weeks, 87% of ASPEN device patients experienced
clinically significant improvement (∆ODI > 10 points) with an
average improvement of 26 ODI points.
QUICKER RECOVERY
Tatsumi RL. Single Level Posterior Lumbar Fusion and Decompression for Degenerative
Spondylolisthesis: Comparison Between Pedicle Screws and Spinous Process
Fixation. Presented at the 2012 Society for Minimally Invasive Spine Surgery (SMISS)
Annual Meeting. Poster on file at LANX, Inc.

16. BEST-IN-CLASS SYSTEM

17. 17LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
ASPEN FAMILY
OF IMPLANT OPTIONS
INDUSTRY-LEADING, COMPREHENSIVE IMPLANT OFFERING
The original
3mm shorter barrel
than the standard
ASPEN implant
Flared plates for improved
fit at L5/S1 and more
anterior placement at
other levels
Low profile alternative;
ideal solution for use with
an interlaminar bone block

18. 18LIT6200-0612.02© 2012 Lanx, Inc. All rights reserved.
COMPARABLE STABILITY
TO PEDICLE SCREWS1,2
PROVEN AND
COMPREHENSIVE DESIGN3
THE ASPEN DEVICE
IS A PROVEN ALTERNATIVE TO PEDICLE SCREWS
QUICKER PATIENT RECOVERY4ROBUST FUSION RATES3
25,000+ implanted by 1,000+ surgeons
1. Karahalios DG, et al. Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. J Neurosurg Spine. 2010. 12(4): 372-380.
2. Kaibara, et al. Biomechanics of a lumbar interspinous anchor with transforaminal lumbar interbody fusion. World Neurosurgery. May 2010. 73(5): 572-577.
3. Amir Vokshoor, et al. Radiographic Evaluation of Fusion and Clinical Outcomes in Minimally Invasive Lumbar Surgery using Spinous Process Fixation.
Data presented at the World Neurosurgical Society, 2012 Annual Meeting, September 2012.
4. Tatsumi RL. Single Level Posterior Lumbar Fusion and Decompression for Degenerative Spondylolisthesis: Comparison Between Pedicle Screws
and Spinous Process Fixation. Presented at the 2012 Society for Minimally Invasive Spine Surgery Annual Meeting. Poster on file at LANX, Inc.