BlueCross BlueShield of Tennessee Medical Policy Manual

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers); Interspinous Fixation (Fusion) Devices

DESCRIPTION

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Interspinous and interlaminar implants (spacers) are proposed to stabilize or distract the adjacent lamina and/or spinous processes and restrict extension to reduce pain in individuals with lumbar spinal stenosis and neurogenic claudication. Interspinous spacers are small devices implanted between the vertebral spinous processes. Interlaminar spacers are implanted between adjacent lamina and spinous processes purportedly to provide dynamic stabilization either following decompressive surgery or as an alternative to decompressive surgery.

Interspinous Fixation (Fusion) Devices

Interspinous fixation (fusion) devices are being developed to aid in the stabilization of the spine. These devices are being evaluated as alternatives to pedicle screw and rod constructs in combination with interbody fusion. These devices differ from interspinous process spacer devices in that they are used for fixation rather than for motion preservation.

Note: This medical policy does not apply to stand-alone cages (see additional information for examples) 

POLICY

• Use of interspinous stabilization/distraction devices (spacers) for all indications, including, but not limited to, use as a treatment for neurogenic intermittent claudication is considered investigational.

• Use of interlaminar stabilization/distraction devices (spacers) for all indications, including, but not limited to, use following decompressive surgery is considered investigational.

• Use of interspinous fixation (fusion) devices for all indications, including, but not limited to, use in combination with interbody fusion or alone for decompression in individuals with spinal stenosis, is considered investigational.

IMPORTANT REMINDERS

• Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.

• We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

ADDITIONAL INFORMATION  

High quality comparative data are limited. Evidence is insufficient to determine the effects of this technology on health outcomes.

The use of specific product names is not a recommendation of one product over another and is not intended to represent a complete listing of all products available.

The following are examples of interspinous and interlaminar stabilization and distraction devices (spacers):

• Aperius® PercLID System (Kyphon/ Medtronic Spine)

• Coflex® Interlaminar Technology implant (Paradigm Spine)

• CoRoent Extensure (Nuvasive)

• DIAM™ Spinal Stabilization System (Medtronic Sofamor Danek)

• ExtenSure (Nuvasive)

• Falena® Interspinous Decompression Device (Mikai Spine)

• FLEXUS™ (Globus Medical)

• HeliFix® Interspinous Spacer System (Alphatec Spine)

• In-Space (Depuy Synthes)

• NL-Prow™ Interspinous Spacer (Non-Linear Technologies)

• Spire™ MIS Spinal Fixation System (Medtronic, Inc.)

• Stenofix (Synthes)

• Superion™ Indirect Decompression System / formerly Superion Interspinous Spacer (Vertiflex, Inc)

• VertiFlex® Spinous Process Fixation Plate

• Wallis® System (Abbott Spine/ Zimmer Spine)

• X-STOP® Interspinous Process Decompression (IPD®) System (Kyphon/ Medtronic Spine)

• X-STOP® PEEK Interspinous Process Decompression (IPD®) System (Kyphon/ Medtronic Spine)

The following are examples of interspinous fixation (fusion) devices:

• AccuFlex (Globus Medical)

• Aerial™ Interspinous Fixation (Globus Medical Inc.)

• Affix™ Next Gen Spinous Process Plate System

• Affix II and Affix II Mini Spinous Process Plating System (NuVasive)

• Aileron™ Interspinous Fixation System (Life Spine)

• Aspen™ MIS Fusion System (Zimmer Biomet)

• Aspen® Spinous Process Fixation System (Lanx)

• Axle™ Interspinous Fusion System (X-Spine)

• BacFuse® Spinous Process Fusion Plate (Pioneer Surgical)

• BAR Posterior Pedicle Screw System (Applied Spine Technologies, Inc.)

• Benefix™ Interspinous Fixation System (U&I Corporation)

• BioFlex® System (Bio-Spine, Inc)

• BridgePoint™ Spinous Process Fixation System (Alphatec Spine)

• CD Horizon Agile™ Dynamic Stabilization Device (Medtronic Sofamor Danek, Inc)

• CD HORIZON® SPIRE™ Spinal System (Medtronic Sofamor Danek)

• Coflex-F® (Paradigm Spine)

• Cosmic™ Posterior Dynamic System (Ulrich GmbH & Co)

• DSS™ Dynamic Stabilization System (Paradigm Spine)

• Dynabolt Dynamic Stabilization System (VertiFlex)

• Dynesys® System (Zimmer, Inc)

• FASS (Fulcrum Assisted Soft Stabilization) (AO International)

• Graf ligamentoplasty/Graf artificial ligament (SEM Co)

• Inspan (Spine Frontier)

• InterBRIDGE® Interspinous Fixation System (LDR Spine)

• IO™ Expandable Lumbar Interbody Fusion System (MiRus™, LLC)

• Isobar Spinal System (Scient’x USA, Inc.)

• Leeds-Keio Ligamentoplasty (Neoligament LTD)

• LemiFlex Spinal Stabilization System (Simpirica Spine)

• Minuteman™ Interspinous Interlaminar Fusion Device (Spinal Simplicity)

• NFix®; Aetna (NFix II Pedicle Screw System); NFix™ II Dynamic Stabilization System (N Spine, Inc)

• Octave™ (Life Spine)

• PrimaLOK™ SP Interspinous Fusion System (OsteoMed Spine)

• REVERE ™ Stabilization System (Globus Medical)

• Satellite™ Spinal System (Medtronic Sofamor Danek, Inc.)

• SP-Fix™ Spinous Process Fixation Plate (Globus Medical)

• Spire™ MIS Spinal Fixation System (Medtronic)

• Stabilimax NZ™ Dynamic Spine Stabilization System (Rachiotek LLC)

• Stabilink MIS Interspinous Fixation Device (Southern Spine)

• TRANSITION® Stabilization System (Globus Medical)

• Viper™ and Expedium ™ (Depuy Spine)

• Zimmer DTO Implant (A hybrid device - combination of the Dynesys & the OPTIMA ZS Spinal System)

• ZIP® MIS Interspinous Fusion System (Aurora Spine)

• Zodiak DynaMo System (Alphatec Spine, Inc)

The following are examples of stand-alone cages:

• A-CIFT SoloFuse (SpineFrontier)

• ACIS cage (Synthes)

• Acromed Lumbar I/F Cage (Depuy)

• Aero AL (Stryker)

• Aero C (Stryker)

• Aesculap PEEK

• Alamo Spine Cage (Alliance Spine)

• Aleutian Spacer System (K2M)

• ALIF Spine Truss System (4web)

• Alphatec Novel TL Spacer System

• Anatomic PEEK PTC cervical fusion system (Medtronic)

• Ancora spacer (Zimmer)

• AnyPlus PEEK TLIF (GS Medical)

• Apache spacer (Genesys)

• Aprevo™ Transforaminal IBF

• Arch ODL spacer (Synthes)

• Arena-C (SpineFrontier)

• Ascential (Stryker)

• Athlet (Signus)

• Avenue-L (Zimmer Biomet)

• AVS Anchor-L Lumbar Cage System (Stryker)

• AVS AS PEEK (Stryker)

• AVS Navigator (Stryker)

• AVS PL PEEK (Stryker)

• BAK Interbody Fusion System (Zimmer)

• Bengal Corpectomy Cage (Depuy)

• BoneBac Interbody System (Thompson MIS)

• Brantigan (DePuy)

• Brigade (Nuvasive)

• Bullet-Tip PEEK VBR/IBF (RTI Surgical)

• CALIX cage (X-Spine)

• Cambria anterior cervical interbody system (Integra\Theken Spine)

• Capstone PEEK Cage (Medtronic)

• Cascadia TL implant system (K2M)

• Cavetto cage (Neurostructures)

• Cezanne II (Accel Spine)

• Chesapeake Spinal System (K2M)

• Cimplicity (SpineSmith)

• Clariance TLIF cage

• Clydesdale (Medtronic)

• Co Roent XL (Nuvasive)

• Coalition Spacer (Globus)

• Concorde Bullet Spine System (DePuy Synthes)

• Construx Mini PTC Spacer System (Orthofix)

• Continental (Globus)

• Corelink Anterior Cervical Interbody Cage System (Foundation)

• Cornerstone PSR Spinal System (Medtronic)

• CoRoent Interbody Cage (Nuvasive)

• Cougar Cage System (Depuy)

• Coveris (Camber)

• C-Plus IBF (Pioneer Sugical\RTI Surgical)

• Crescent cage (Medtronic)

• Devex TLIF Cage (DePuy)

• Dorado (Spine Frontier)

• Ebi PEEK optima spacer (Biomet)

• Emerald cervical PEEK system (Glasir)

• Eminent Sidewinder DLIF PEEK Cage

• Endoskeleton TCS (Titan Spine)

• Express IBFD (Advanced Vertebral Solutions)

• Foundation Cervical Interbody Device (CoreLink)

• Fuse (Medtronic)

• FuseLox Lumbar Cage (Captiva Spine)

• Harpoon, Hawkeye, Hornet, Shark (ChoiceSpine)

• Honour cage (Nexxt Spine)

• Honour Orb (Nexxt Spine)

• IN:C2 spacer (SpineSmith)

• InFill Lateral Interbody Device (Pinnacle Spine)

• Innovasis Box PEEK IBF System

• Innovasis C-Box PEEK cage

• Interfuse - T (Vertebral Technologies)

• Irix-C (X Spine)

• Juliet TL Lumbar Interbody Fusion Device (Spineart)

• LANX Lateral Cage

• LDR ROI-A Implant System

• Leopard (DuPuy)

• Levo fixed cage (non-expandable) (Alphatec Spine)

• LLC Reveal VBR System (Theken)

• Lucent Magnum (Spinal Elements)

• Lucent TiBond Interbody System (Spinal Elements)

• Luna Interbody Fusion System (Benvenue)

• Magnum + Stand-alone Lumbar Interbody Fusion system (Spinal Elements)

• Maxim Surgical X-Treme interbody fusion system

• MectaLIF transforaminal lumbar interbody fusion device (Genesys)

• Medyssey BN

• NanoLOC (Titan)

• Nanovis cage

• Novel Spinal System (Alphatec Spine)

• OLIF PEEK (Medtronic)

• OLIF 51 (Medtronic)

• Orio-AL, Orio-C, Orio-PL, Orio-TL (SpineCraft)

• Osteofix Pillar (AL, SA, PL, TL)

• OsteoStim (Biomet)

• Pathway AVID (Custom Spine)

• Pillar SA PEEK Spacer (Orthofix)

• Pioneer Interbody Fusion (IBF)/Vertebral Body Replacement System (C-Plus)

• Precision Vault ALIF System (Precision Spine)

• Prevail Interbody Device (Medtronic)

• PRO-LINK Stand-Alone Cervical Spacer System (Life Spine)

• Pulse cervical cage system (DePuy)

• Ravine (K2M)

• Ray Threaded Fusion Cage (Synthes)

• Renovis PEEK ALIF Cage

• ROI-C (LDR)

• Scarlet AC-T Secured Anterior Cervical Cage (SpineArt)

• Silverstone IBF System (Altus Spine)

• Solitaire C Cervical Spacer System (Biomet)

• Spine 360 plate & cage for cervical fusion

• Spine 360 Cervical Interbody Fusion System

• Spine Vu c-POD Intervertebral Body Fusion Device (Integra\Theken)

• Stalif-C (Cervical Cage) (Centinel Spine)

• Stalif Midline and Stalif Midline ABO Screws (Centinel Spine)

• Stingray (Spine 360)

• Surgical Titanium Mesh (Depuy)

• Sustain-O (Globus)

• Syncage (Synthes)

• SYNFIX LR system (Synthes)

• T-Pal (Synthes)

• Timberline Cage (Lanx)

• TiNano (Aurora Spine)

• TiLink-T (Acuity Surgical)

• Titanium PL cage (Stryker)

• Tomcat (Choice Spine)

• Transcontinental (Globus)

• Tryptik CA (Spineart)

• Valeo C (Amedica)

• Valeo II LL (Amedica)

• Vault ALIF system (Precision Spine)

• Velofix (U & I Corporation)

• Vertigraft (Lifenet)

• Vertu TiBond PEEK cage

• Vu POD (Integra\Theken)

• XP L Spinal System (Arcadius)

• Zavation PEEK cage

• Zero-P Zero-Profile Anterior Cervical Interbody Fusion Device (Synthes)

• Zeus A (Amendia)

• Zeus C cervical spacer (Amendia)

• Zeus L (Amendia)

• Zeus T (Amendia)

• Zimmer TM-S cervical fusion device

• Zyston Curved Spacer System (Biomet)

• Zyston Straight Spacer System (Biomet)

SOURCES  

Bae, H., Lauryssen, C., Maislin, G., Leary, S., & Musacchio, Jr., M. (2015). Therapeutic sustainability and durability of Coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International Journal of Spine Surgery, 9 (15), 1-8. (Level 4 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Interspinous and interlaminar stabilization/distraction devices (spacers) (7.01.107). Retrieved October 4, 2023 from https://www.evidencepositioningsytem.com/. (61 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Interspinous fixation (fusion) devices (7.01.138). Retrieved October 4, 2023 from https://www.evidencepositioningsytem.com/. (6 articles and/or guidelines reviewed)

Ghany, A., Amer, A., Saeed, K., Emara, E., Hamad, A., Nosseir, M. (2016). Evaluation of interspinous spacer outcomes in degenerative lumbar canal stenosis: clinical study. World Neurosurgery, Epub ahead of print. Abstract retrieved November 18, 2016 from PubMed database.

Kim, D. H., Shanti, N., Tantorski, M.E., Shaw, J. D., Li, L., Martha, J. F., et al. (2012). Association between degenerative spondylolisthesis and spinous process fracture after interspinous process spacer surgery. The Spine Journal, 12 (6), 466-472. (Level 3 evidence)

Lopez, A., Scheer, J., Dahdaleh, N., Patel, A., & Smith, Z. (2017). Lumbar spinous process fixation and fusion: a systematic review and critical analysis of an emerging spinal technology. Clinical Spine Surgery, 30 (9), 1279-1288. Abstract retrieved October 23, 2017 from PubMed database.

Moojen. W.A., Arts, M.P., Jacobs, W.C.H., van Zwet, E.W.,van den Akkervan Marle, M.E., Koes, B.W., et al. (2013). Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. British Medical Journal, 347: f6415, doi: 10.1136. (Level 2 evidence)

National Institute for Health and Clinical Excellence (NICE). (2010, November). Interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication. Retrieved November 12, 2014 from http://www.nice.org.uk.

North American Spine Society. (2011). Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of degenerative lumbar spinal stenosis. Retrieved February 3, 2016 from https://www.spine.org/Portals/0/Assets/Downloads/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf.

North American Spine Society. (2014). Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of degenerative lumbar spondylolisthesis, 2nd ed. Retrieved February 3, 2016 from https://www.spine.org/Portals/0/Assets/Downloads/ResearchClinicalCare/Guidelines/Spondylolisthesis.pdf.

Phan, K., Rao, P. J., Ball, J. R., & Mobbs, R. J. (2016). Interspinous process spacers versus traditional decompression for lumbar spinal stenosis: systematic review and meta-analysis. Journal of Spine Surgery, 2 (1), 31-40. (Level 4 evidence)

U. S. Food and Drug Administration. (2010, August). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K100354 (PrimaLOK®). Retrieved November 17, 2016 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2010, September). Center for Devices and Radiological Health. Pre-market Notification Database. K103205 (BridgePoint™). Retrieved February 3, 2016 from http://www.accessdata.fda.gov.  

U. S. Food and Drug Administration. (2013, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K131238 (Affix®). Retrieved November 17, 2016 from http://www.accessdata.fda.gov.  

Winifred S. Hayes, Inc. Medical Technology Directory. (2018, September; last updated search December 2022). Coflex interlaminar stabilization device (Surgalign Spine Techologies Inc.) for treatment of lumbar spinal stenosis. Retrieved October 5, 2023 from www.Hayesinc.com/subscribers. (67 articles and/or guidelines reviewed)

Wu, A. M., Zhou, Y., Li, Q. L., Wu, X. L., Jin, Y. L., Luo, P., et al. (2014). Interspinous spacer versus traditional decompressive surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PloS One, 9 (5), e97142. (Level 3 evidence)

ORIGINAL EFFECTIVE DATE:  6/8/2013

MOST RECENT REVIEW DATE:  11/9/2023

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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