Overview

WHAT IS THE ASPENTM MIS FUSION SYSTEM?

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FUSION vs. NON-FUSION

The ASPEN device is not an “interspinous spacer”

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FUSION vs. NON-FUSION

The ASPEN device is a less invasive option to pedicle screws for

fixation/fusion

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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

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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.

CLINICAL APPLICATIONS

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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.

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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).

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“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

PROVEN BIOMECHANICAL & CLINICAL SUCCESS

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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.

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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

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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.

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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.

BEST-IN-CLASS SYSTEM

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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

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COMPARABLE STABILITY TO PEDICLE SCREWS1,2

PROVEN AND COMPREHENSIVE DESIGN3

THE ASPEN DEVICE IS A PROVEN ALTERNATIVE TO PEDICLE SCREWS

QUICKER PATIENT RECOVERY4 ROBUST 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.