Footnotes

Current revision: B

1000-000-002

Current Revision Date: 07.31.17

  1. Alò K, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: clinical response in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Practice 2004; 4:19-29
View past revisions

Current revision: C

1000-001-210

Current Revision Date: 07.31.17

  1. North American Spine Society. Back Pain is a Big Issue for U.S. Adults: NASS Survey Results Show More than Half the Population Suffers. SpineLine NASS News, November/December 2004. p49. View Article, Accessed May 29, 2014.
  2. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain. A randomized double-blind trial. Spine. 2008 May 20;33(12):1291-7; discussion 1298.
  3. International Spine Intervention Society. Practice Guidelines for Spinal Diagnostic and Treatment Procedures. Percuteneous radiofrequency lumbar medial branch neurotomy. pp188-218.
  4. Fenton DS, Czervionke LF. Chapter 3 Facet Denervation. Image-Guided Spine Intervention 1st Ed. Saunders 2002; p 51-71.
  5. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician 2007 Jan;10(1):229-53.
  6. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000 May 15;25(10):1270-7.
  7. Boswell MV, Colson JD, Spillane WF. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician 2005 Jan;8(1):101-14
  8. Burnham RS, Yasui Y. An alternate method of radiofrequency neurotomy of the sacroiliac joint: a pilot study of the effect on pain, function, and satisfaction. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):12-9.
  9. Bogduk N. Management of chronic low back pain. Med J Aust. 2004 Jan 19;180(2):79-83
View past revisions

Current revision: Rev B

1000-001-358

Current Revision Date: 08.10.20

  1. Kochan J. (2015, Nov 4). Percutaneous vertebroplasty and kyphoplasty. Retrieved from: https://emedicine.medscape.com/article/1835633-overview#a7
  2. McCarthy J and Davis A. Diagnosis and management of vertebral compression fractures. American Family Physician. 2016; 94(1):44-50
  3. Jensen M et al. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. American Journal of Neuroradiology. 2007; 28(8):1439-1443.
  4. Wardlaw D et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): A randomised controlled trial. The Lancet. 2009; 373(9668):1016-1024.
  5. Beall D et al. Prospective and multicenter evaluation of outcomes for quality of life and activities of daily living for balloon kyphoplasty in the treatment of vertebral compression fractures: The EVOLVE trial. Neurosurgery. 2019; 84(1): 169-178.
View past revisions

Current revision: Rev None

1000-001-358

Current Revision Date: 12.04.15

  1. North American Spine Society. Back Pain is a Big Issue for U.S. Adults: NASS Survey Results Show More than Half the Population Suffers. SpineLine NASS News, November/December 2004. p49. View Article, Accessed May 29, 2014.
  2. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain. A randomized double-blind trial. Spine. 2008 May 20;33(12):1291-7; discussion 1298.
  3. International Spine Intervention Society. Practice Guidelines for Spinal Diagnostic and Treatment Procedures. Percuteneous radiofrequency lumbar medial branch neurotomy. pp188-218.
  4. Fenton DS, Czervionke LF. Chapter 3 Facet Denervation. Image-Guided Spine Intervention 1st Ed. Saunders 2002; p 51-71.
  5. Burnham RS, Yasui Y. An alternate method of radiofrequency neurotomy of the sacroiliac joint: a pilot study of the effect on pain, function, and satisfaction. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):12-9.
  6. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician 2007 Jan;10(1):229-53.
  7. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000 May 15;25(10):1270-7.
View past revisions

Current revision: Rev A

1000-025-001

Current Revision Date: 05.09.17

  1. Alò K, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: clinical response in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2004; 4(1):19-29
  2. Carey TS, Garrett J, Jackman A, Mclaughlin C, Fryer J, Smucker D. The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons. The North Carolina Back Pain Project. N Eng J Med. 1995; 333(14):913-7
  3. Buenaventura RM, Shah RV, Patel V, Benyamin R, Singh V. Systematic review of discography as a diagnostic test for spinal pain: an update. Pain Physician 2007 Jan;10(1):147-64
  4. Amoretti N, David P, Grimaud A, Flory P, Hovorka I, Roux C, Chevallier P, Bruneton JN. Clinical follow-up of 50 patients treated by percutaneous lumbar discectomy. Clinical Imaging. 2006; 30(4):242-4
  5. Derby R, Howard MW, Grant JM, Lettice JJ, Van Peteghem PK, Ryan DP. The ability of pressure-controlled discography to predict surgical and nonsurgical outcomes. Spine 1999 Feb 15;24(4):364-72
  6. Alò KM, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: one-year follow-up in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2005; 5(2):116-23
  7. Alò K, Wright RE, Fu ZJ. Open human torso laboratory dissection with annular and nuclear lumbar disc analysis pre and post Dekompressor®. Denver, CO: University of Colorado Health Sciences Center College of Medicine, Department of Anatomy; January 19/20, 2003
  8. Wright R. Preclinical laboratory analysis of Dekompressor® percutaneous decompression in sheep and human cadaver discs: Internal Data. Fort Collins, CO: Colorado State University; May 2000
  9. Onik G, Maroon J, Helms C, Schweigel J, Mooney V, Kahanovitz N, Day A, Morris J, McCulloch JA, Reicher M. Automated percutaneous diskectomy: initial patient experience. Work in progress. Radiology. 1987; 162(1 Pt 1):129-32
  10. Davis, GW, Onik G. Clinical experience with automated percutaneous discectomy. Clin Orthop Relat Res. 1989; 238:98-103
  11. Onik G, Mooney V, Maroon JC, Wiltse L, Helms C, Schweigel J, Watkins R, Kahanovitz N, Day A, Morris J, et al. Automated percutaneous discectomy: a prospective multi-institutional study. Neurosurgery. 1990; 26(2):228-32; discussion 232-3
  12. Maroon JC, Onik G, Sternau L. Percutaneous automated discectomy. A new approach to lumbar surgery. Clin Orthop Relat Res. 1989; 238:64-70
  13. Gill K, Blumenthal SL. Clinical experience with automated percutaneous discectomy: the Nucleotome system. Orthopedics. 1991; 14(7):757-60
  14. Gill K, Blumenthal SL. Automated percutaneous discectomy. Long-term clinical experience with the Nucleotome system. Acta Orthop Scand Suppl. 1993; 251:30-3
  15. Castro WH, Jerosch J, Hepp R, Schulitz KP. Restriction of indication for automated percutaneous lumbar discectomy based on computed tomographic discography. Spine. 1992; 17(10):1239-43
  16. Yeo SJ, Tay BK. Clinical experience with automated percutaneous discectomy. Singapore Med J. 1993; 34(4):313-5
  17. Mathews R, Kent G, Miller M. APLD: A prospective study in an outpatient surgical setting. ISIS Newsletter, 1997
  18. Mariconda M, Galasso O, Secondulfo V, Rotonda GD, and Milano C. Minimum 25-year outcome and functional assessment of lumbar discectomy. Spine. 2006; 31(22):2593-9
View past revisions

Current revision: Rev E

1000-025-036

Current Revision Date: 07.08.16

  1. National Osteoporosis Foundation. What is Osteoporosis? http://www.nof.org/articles/7. Accessed Aug. 6, 2013
  2. Cooper G. Overview of Osteoporotic Compression Fractures. eMedicine. May 14, 2013. http://emedicine.medscape.com/article/325872-overview. Accessed July 24, 2013
  3. Lovi a, Teli M, ortolina A, et al. Vertebroplasty and Kyphoplasty: Complementary Techniques for the Treatment of Painful Osteoporotic Vertebral Compression Fractures. A Prospective Non-randomized Study on 154 Patients Eur Spine Jour (2009) 18 (Suppl 1):S95-S101
  4. Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures. Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA. Sept. 8, 2008.
  5. Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty. Anesthesiol Clin. 2007 Dec;25(4):913-28.
  6. Kochan, J. "Vertebroplasty and Kyphoplasty, Percutaneous." eMedicine. November 4, 2015. http://emedicine.medscape.com/article/423209-overview. Accessed April 20, 2016.
  7. Garfin SR, Buckley RA, Ledlie J; Balloon Kyphoplasty Outcomes Group. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine. 2006 Sep 1;31(19):2213-20.
  8. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures. Spine. 2001 Jul 15;26(14):1631-8.
  9. Independent lab results from Fluid Dynamics Inc. commissioned by Stryker July 2009. Testing conducted at 20-21° C (68-70° F).
  10. Erbe, et al., Comparison of a new bisphenol-a-glycidyl dimethacrylate-based cortical bone void filler with polymethylmethacrylate, Eur Spine J, 2001, 10: S147-S152.
  11. Szymborski et al., Characterization of Properties Influencing the Fill and Flow Behavior of Bone Augmentation Materials. Transactions of the 56th Annual Meeting of the Orthopaedic Research Society, 2010.
  12. Erbe et al., Cortoplasty: Augmentation of Osteoporotic Vertebral Compression Fractures with Cortoss. Transactions of the 32 meeting of the Society for Biomaterials, 2007.
  13. Carroll, et al., Characteristics of Orthopaedic Composites Used in Vertebral Augmentation, Transactions of the 31st Annual Meeting of the Society for Biomaterials, 2006.
  14. Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine. 2012; 37(7): 544-550
  15. An and Draugn, Mechanical Testing of Bone and the Bone-Implant Interface. CRC Press, New York, 2000.
  16. Burstein, A.H., et al., Aging of bone tissue: mechanical properties. JBJS-Am, 1976, 58(1): 82-86.
  17. Martin and Burr, Structure, Function, and Adaptation of Compact Bone. Raven Press, New York, 1989.
  18. Reilly and Burstein, The Elastic and Ultimate Properties of Compact Bone Tissue. J.Biomechanics, 1975, 8:393-405.
  19. Pomrink et al., A Comparison of the Mechanical and Thermodynamic Properties of a Novel In-Situ Polymerized Orthopaedic Composite Cement. Transactions of the 46th Annual Meeting of the Orthopaedic Research Society, 2000.
  20. Darmoc et al., Cyclic Fatigue Properties of Vertebral Augmentation Materials. Transactions of the 55th meeting of the Orthopaedic Reasearch Society, 2009.
  21. Havener, M. Report – Compression Testing of Cortoss and SpinePlex. Document Number 1010-0003CR2.
  22. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 11
  23. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 22
  24. An Evaluation of the Safety and Efficacy of an Alternative Material to Polymethylmethacrylate Bone Cement for Vertebral Augmentation. Stryker Literature Number 5702-0004, Rev. 00
  25. Deramond H, Wright NT, Belko? SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, 1999. Vol 25 (2) 17S-21S.
  26. Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) 1023-1031.
  27. Cortoss Bone Augmentation Material: Instructions for Use (IFU)
  28. Palussière, Jean et al. "Clinical Results Of An Open Prospective Study Of A Bis-GMA Composite In Percutaneous Vertebral Augmentation". European Spine Journal 14.10 (2005): 982-991. Web. 18 Aug. 2016.
  29. Bae, Hyun et al. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web.
View past revisions

Current revision: Rev None

1000-025-377

Current Revision Date: 12.04.15

  1. North American Spine Society. Back Pain is a Big Issue for U.S. Adults: NASS Survey Results Show More than Half the Population Suffers. SpineLine NASS News, November/December 2004. p49. View Article, Accessed May 29, 2014.
View past revisions

Current revision: A

1000-025-418

Current Revision Date: 07.31.17

  1. North American Spine Society. Back Pain is a Big Issue for U.S. Adults: NASS Survey Results Show More than Half the Population Suffers. SpineLine NASS News, November/December 2004. p49. View Article, Accessed May 29, 2014.
  2. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain. A randomized double-blind trial. Spine. 2008 May 20;33(12):1291-7; discussion 1298.
  3. International Spine Intervention Society. Practice Guidelines for Spinal Diagnostic and Treatment Procedures. Percuteneous radiofrequency lumbar medial branch neurotomy. pp188-218.
  4. Fenton DS, Czervionke LF. Chapter 3 Facet Denervation. Image-Guided Spine Intervention 1st Ed. Saunders 2002; p 51-71.
  5. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician 2007 Jan;10(1):229-53.
  6. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000 May 15;25(10):1270-7.
  7. Boswell MV, Colson JD, Spillane WF. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician 2005 Jan;8(1):101-14
  8. Burnham RS, Yasui Y. An alternate method of radiofrequency neurotomy of the sacroiliac joint: a pilot study of the effect on pain, function, and satisfaction. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):12-9.
  9. Bogduk N. Management of chronic low back pain. Med J Aust. 2004 Jan 19;180(2):79-83
View past revisions

Current revision: Rev A

1000-025-419

Current Revision Date: 07.31.17

  1. Jinks C, Jordan K, Croft P. Measuring the population impact of knee pain and disability with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain. 2002;100:55–64.
  2. Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: A double-blind randomized controlled trial. Pain 2011;152:481-487.
View past revisions

Current revision: A

1000-025-537

Current Revision Date: 08.02.17

Bayley, Edward, et al. “Clinical Outcomes of Sacroplasty in Sacral Insufficiency Fractures: a Review of the Literature.” European Spine Journal, vol. 18, no. 9, June 2009, pp. 1266–1271., doi:10.1007/s00586-009-1048-z

View past revisions

Current revision: Rev None

1000-025-789

Current Revision Date: 01.19.17

  1. Kochan, J. "Vertebroplasty and Kyphoplasty, Percutaneous." eMedicine. July 25, 2013. http://emedicine.medscape.com/article/423209-overview. Accessed August 29, 2013.
  2. Garfin SR, Buckley RA, Ledlie J; Balloon Kyphoplasty Outcomes Group. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine. 2006 Sep 1;31(19):221320. 
  3. Cooper G. Overview of Osteporotic Compression Fractures. eMedicine. May 14, 2013.http://emedicine.medscape.com/article/325872-overview. Accessed July 24, 2013.
  4. Becker, Stephan, ed. and Michael Ogon ed. Balloon Kyphoplasty. 1 ed. New York: Springer, 2008. Print. p. 56.
  5. Mathis JM., ed, Deramond H., ed, and Belkoff SM, ed. Percutaneous Vertebroplasty and Kyphoplasty. 2 ed. New York: Springer Science+Business Media, Inc., 2006. Print. p. 136. 
  6. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for Vertebral Compression Fracture (FREE): a Randomized Controlled Trial. Lancet. 2009 Mar 21;373(9668):1016-24. 
  7. Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures. Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA. Sept. 8, 2008.
  8. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures. Spine. 2001 Jul 15;26(14):1631-8.
  9. Siemionow K, Lieberman IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Curr Opin Support Palliat Care. 2009 Sep;3(3):219-25.
  10. Taylor RS, Taylor RJ, Fritzell P. Ballon kyphoplasty and vertebroplasty for vertebral compression fractures: A comparative systematic review of efficacy and safety. Spine. 2006 Nov 1;31(23):2747-55.
  11. Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta- analysis. Eur Spine J. 2007 Aug;16(8):1085-100. Epub 2007 Feb 3.
View past revisions

Current revision: None

1000-025-835

Current Revision Date: 07.31.17

  1. Jinks C, Jordan K, Croft P. Measuring the population impact of knee pain and disability with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain. 2002;100:55–64.
  2. Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: A double-blind randomized controlled trial. Pain 2011;152:481-487.
View past revisions

Current revision:

D0000007218

Current Revision Date: 08.03.20

  1. Riggs B. and Melton L. The worldwide problem of osteoporosis: Insights afforded by epidemiology. Bone. 1995; 17(Suppl 5):S505-S511.
  2. Alexandru D. and So W. Evaluation and management of vertebral compression fractures. Permanente Journal. 2012; 16(4):46-51.
  3. National Institute of Health Osteoporosis and Related Bone Diseases National Resource Center. (2018). Osteoporosis Overview. Retrieved from https://www.bones.nih.gov/health-info/bone/osteoporosis/overview.
  4. Lips P. and Van Schoor N. Quality of life in patients with osteoporosis. Osteoporosis International. 2005; 16(5):447-455.
  5. Landgon J. et al. Vertebral compression fractures - new clinical signs to aid diagnosis. Annals of the Royal College of Surgeons of England. 2010;92(2):163-166.+
  6. Mathis J., Deramond H., and Belkoff S. (2006). Percutaneous vertebroplasty and kyphoplasty. New York, NY: Springer Science+Business Media, Inc. Retrieved from https://rd.springer.com/content/pdf/10.1007%2F0-387-36083-2.pdf.
  7. SpineJack System Instructions for Use. Balma, France: Vexim SA; 2018.
  8. Noriega D et al. A prospective, international, randomized, non-inferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.07.009.
View past revisions

Current revision:

D0000015872

Current Revision Date: 07.29.19

  1. The bioactive response of Cortoss has not been assessed in any clinical investigation and the results from laboratory or animal testing may not be predictive of human clinical experience
  2. U.S. Food and Drug Administration, Center for Devices and Radiological Health. SpineJack Expansion Kit 510(k) Summary (K181262). Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181262
  3. Tzermiadianos M et al. Altered disc pressure profile after an osteoporotic vertebral fracture is a risk factor for adjacent vertebral body fracture. European Spine Journal. 2008; 17:1522-1530
  4. Hulme P et al. Vertebroplasty and kyphoplasty: A systematic review of 69 clinical studies. Spine. 2006; 31(17):1983-2001.
  5. iVAS Elite Inflatable Vertebral Augmentation System Instructions for Use: 0808-000-700 Rev-AA
  6. As compared to larger gauge sizes
  7. As of July 2019
  8. Based on fill volume
  9. As of July 2019
  10. An Evaluation of the Safety and Efficacy of an Alternative Material to Polymethylmethacrylate Bone Cement for Vertebral Augmentation. 5702-0004, Rev. 00
  11. Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine, first published on July 5, 2011 as doi: 10.1097/ BRS.0b013e31822ba50b
  12. Deramond H, Wright NT, Belko? SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, 1999. Vol 25 (2) 17S-21S
  13. Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) 1023-1031
  14. Cortoss Bone Augmentation Material: Instructions for Use (IFU)
  15. Palussière, Jean et al. "Clinical Results Of An Open Prospective Study Of A Bis-GMA Composite In Percutaneous Vertebral Augmentation". European Spine Journal 14.10 (2005): 982-991. Web. 18 Aug. 2016
  16. Bae, Hyun et al. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web
  17. Independent lab results from Fluid Dynamics Inc. commissioned by Stryker July 2009. Testing conducted at 20-21° C (68-70° F)
  18. The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p. 11
  19. Orthopaedic Industry Annual Report: 2008-2009. Orthoworld, Inc. 2009, p. 22
  20. Based on 18g Venom Cannula and Electrode System
  21. Stryker Corporation. (2013). Effect of the Stryker Venom Cannula and Venom Electrode Combination on Lesion Size and Anesthesia Delivery During Radiofrequency Ablation[Clinical white paper, 1000-025-195 Rev None]. Kalamazoo, MI.
  22. Amoretti N, David P, Grimaud A, Flory P, Hovorka I, Roux C, Chevallier P, Bruneton JN. Clinical follow-up of 50 patients treated by percutaneous lumbar discectomy. Clinical Imaging. 2006; 30(4):242-4
  23. Alò K, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: clinical response in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Practice 2004; 4:19-29
  24. Alò KM, Wright RE, Sutcliffe J, Brandt SA. Percutaneous lumbar discectomy: one-year follow-up in an initial cohort of 50 consecutive patients with chronic radicular pain. Pain Pract. 2005; 5(2):116-23
  25. Alò K, Wright RE, Fu ZJ. Open human torso laboratory dissection with annular and nuclear lumbar disc analysis pre and post Dekompressor®. Denver, CO: University of Colorado Health Sciences Center College of Medicine, Department of Anatomy; January 19/20, 2003
  26. Wright R. Preclinical laboratory analysis of Dekompressor® percutaneous decompression in sheep and human cadaver discs: Internal Data. Fort Collins, CO: Colorado State University; May 2000
View past revisions

Current revision: D0000023001

D0000023001

Current Revision Date: 06.23.20

  1. McCarthy J et al. Diagnosis and management of vertebral compression fractures. American Family Physician. 2016; 94(1):44-50.
  2. Burge R et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. Journal of Bone and Mineral Research. 2007; 22(3):465-475.
  3. Transparency Research Market. Minimally Invasive Vertebral Compression Fracture Repair Market Expected to Reach USD 2.82 Billion Globally in 2019: Transparency Market Research. PR Newswire: News Distribution, Targeting and Monitoring 07 Feb 2014. Available at: http://www.prnewswire.com/news-releases/minimally-invasive-vertebral-compression-fracture-repair-market-expected-to-reach-usd-282-billion-globally-in-2019-transparency-market-research-244199351.html
  4. Millennium Research Group. Minimally invasive vertebral compression fracture treatments, Market Insights, Global. March 2019, p.44.
  5. Noriega D et al. A prospective, international, randomized, non-inferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.07.009.
  6. Kyphon Interventional Therapies Product Catalog (2016). Available at: http://www.medtronic.com/content/dam/medtronic-com/products/spinal-orthopaedic/vertebroplasty/kyphon-interventional-product-catalog-201608691EN.pdf
  7. Medtronic HV-R Fenestrated Screw Cement Instruction for Use: M708348B496E Rev B.
  8. Kyphon Xpede Bone Cement Instructions for Use: M708348B093E Rev E.
  9. Kyphon ActivOs 10 Bone Cement with Hydroxyapatite Instructions for Use: M708348B092 Rev C.
  10. Medtronic. (2011, May 16). Medtronic launches quick-to-dough bone cement in the United States. Fierce Biotech. Available at: https://www.fiercebiotech.com/biotech/medtronic-launches-quick-to-dough-bone-cement-united-states
  11. Medtronic. (2011, May 17). Medtronic announces U.S. launch of Kyphon Xpede bone cement for spinal fracture treatment. Life Sciences. Available at: https://www.news-medical.net/news/20110517/Medtronic-announces-US-launch-of-Kyphon-Xpede-Bone-Cement-for-spinal-fracture-treatment.aspx
  12. Theuer K et al. (2011, Jan 13). In-vitro bioactivity and physical properties of materials for vertebral augmentation. Poster presentation at the Annual Meeting of the Orthopaedic Research Society, Long Beach, CA. Available at: https://www.ors.org/Transactions/57/0775.pdf.
  13. Stryker Corporation (2018). Performance of a new vertebral augmentation balloon: A comparative study. iVAS Elite balloon vs Medtronic Express and Express II balloons [Clinical white paper, 1000-0. (20125-893]. Kalamazoo,MI.
  14. StabiliT Vertebral Augmentation System Instructions for Use: 403303001 MLP_001 2018-05-17.
  15. StabiliT Vertebral Augmentation System Brochure. (2017). Available at: https://www.merit.com/wp-content/uploads/2017/03/401803001_A.StabiliT-System-Brochure.6_panel.web_.pdf
  16. StabiliT MX Vertebral Augmentation System Brochure. (2017). Available at: https://www.merit.com/wp-content/uploads/2017/03/402534001-B-StabiliTMX.pdf
  17. StabiliT VP Vertebroplasty System website. Available at: https://www.merit.com/interventional-oncology-spine/vertebral-compression-fracture/vcf/stabiliit-vp-vertebral-augmentation-system/#tab-id-2
  18. Osseoflex SB Steerable Balloon and Straight Balloon Instructions for Use: 403745001MLP_001 2017-10-10.
  19. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Arcadia Balloon Catheter 510(k) K191596 clearance letter, 09 October 2019. Retrieved May 22, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191596.pdf 
  20. Merit Medical PMMA bone cement sheet. Available at: https://www.merit.com/wp-content/uploads/2017/07/403580001-A.pdf
  21. Merit Medical Osseoperm Mendec bone cement sheet. Available at: https://www.merit.com/wp-content/uploads/2017/07/704014001-A.pdf
  22. MAUDE Adverse Event Report for Osseoflex 1.0 Steerable Needle. Available at:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1799442
  23. Johnson & Johnson HealthCare Professional website. Available at: https://www.depuysynthes.com/hcp/spine/procedures/qs/vertebral-body-augmentation
  24. Confidence Spinal Cement System Instructions for Use: 0902-90-125 Rev B. 
  25. Confidence Spinal Cement System Surgical Technique and Product Catalog. Available at:    http://synthes.vo.llnwd.net/o16/LLNWMB8/INT%20Mobile/Synthes%20International/Product%20Support%20Material/legacy_Synthes_PDF/9085-92-000.pdf  
  26. Vertecem Vertebroplasty System Technique Guide. Available at:    https://www.dshuddle.com/sites/default/files/documents/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/DSUSSPN09140450_Vertecem_TechniqueGuide_LoRes.pdf
  27. Kiva VCF Treatment System Procedural Technique Guide. Available at: https://static1.squarespace.com/static/5cba31329b8fe86db05fc0eb/t/5d110f89af4ef0000100c7d5/1561399209386/Kiva+Procedural+Guide
  28. Tutton S et al. KAST Study: The kiva system as a vertebral augmentation treatment – A safety and effectiveness trial. Spine. 2015; 40(12):865-875.
  29. Blazer-C vertebral augmentation system brochure. Available at:   https://static1.squarespace.com/static/5cba31329b8fe86db05fc0eb/t/5d11171b24b1090001bee6d3/1561401116585/L128+Blazer+Surgeon+Brochure%2C+Rev.+A.pdf 
  30. IZI Medical Products Osteo-site cement features and benefits guide. Available at:  https://static1.squarespace.com/static/5cba31329b8fe86db05fc0eb/t/5d111fa4c4cf88000160b026/1561403301114/Osteo-Site+Cement.pdf
  31. IZI Medical Osteo-site cements website. Available at: https://izimed.com/products/osteo-site-cements
  32. PanMed US product website. Available at: http://www.panmed.us/about.php
  33. Globus Medical product website. Available at: http://www.globusmedical.com/algeatherapies/
  34. MAUDE Adverse Event Report for AFFIRM Access Pack. Available at:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5450350&pc=FSH
View past revisions

Current revision: D0000066127 AA

D0000066127 AA

Current Revision Date: 05.11.21

  1. Waterman B et al. Low back pain in the United States: Incidence and risk factors for presentation in the emergency setting. The Spine Journal. 2012; 12:63-70.
  2. Beaumont. (2021). Back, spine, and neck mobility. Retrieved from: https://www.beaumont.org/conditions/back-spine-and-neck-mobility.
  3. Highsmith J. (2019, May 15). Balloon kyphoplasty: Frequently asked questions. Retrieved from: https://www.spineuniverse.com/resource-center/spinal-fractures/balloon-kyphoplasty-frequently-asked-questions.
  4. Kochan J. (2015, November 4). Percutaneous vertebroplasty and kyphoplasty. Retrieved from: https://emedicine.medscape.com/article/1835633-overview#a7.
View past revisions

Current revision: D0000068200

D0000068200

Current Revision Date: 01.19.21

  1. American Physical Therapy Association (2012, Apr 4). Most Americans live with low back pain - and don't seek treatment. Retrieved from: https://www.prweb.com/releases/apta/low_back_pain_survey/prweb9366244.htm
  2. Conger A et al. The effectiveness of radiofrequency ablation of medial branch nerves for chronic lumbar facet joint syndrome in patients selected by guideline-concordant dual comparative medial branch blocks. Pain Medicine. 2020; 21(5):902-909.
  3. Cetin A and Yektas A. Evaluation of the short- and long-term effectiveness of pulsed radiofrequency and conventional radiofrequency performed for medial branch block in patients with lumbar facet joint pain. Pain Research and Management. 2018; 2018:7492753.
  4. Son J et al. The efficacy of repeated radiofrequency medial branch neurotomy for lumbar facet syndrome. Journal of Korean Neurosurgical Society. 2010; 48(3):240-243.
  5. Boswell M et al. Therapeutic facet joint interventions in chronic spinal pain: A systematic review of effectiveness and complications. Pain Physician. 2005; 8(1):101-114.
  6. Boswell M et al. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007; 10(1):229-253.
  7. Dreyfuss P et al. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000; 25(10):1270-1277.
  8. Girasole G. (2019, July 25). Facet joint syndrome. Retrieved from: https://www.spineuniverse.com/conditions/spinal-disorders/facet-joint-syndrome
  9. Parker L. (2020, June 24). Symptoms and diagnosis of facet joint disorders. Retrieved from: https://www.spine-health.com/conditions/arthritis/symptoms-and-diagnosis-facet-joint-disorders
  10. Kennedy D. (2019, April 23). Radiofrequency ablation (RFA): Procedure and recovery. Retrieved from: https://www.spine-health.com/treatment/injections/radiofrequency-ablation-rfa-procedure-and-recovery
  11. Richeimer S. (2019, March 6). Radiofrequency ablation treatment for neck, back and sacroiliac pain. Retrieved from: https://www.spineuniverse.com/treatments/pain-management/radiofrequency-ablation-treatment-neck-back-sacroiliac-pain
  12. Nath S et al. Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current in the management of chronic low back pain: A randomized double-blind trial. Spine. 2008; 33(12):1291-1297.
  13. Kennedy D. (2019, April 23). Radiofrequency ablation (RFA) side effects and risks. Retrieved from: https://www.spine-health.com/treatment/injections/radiofrequency-ablation-rfa-side-effects-and-risks
View past revisions

Current revision: D0000068686 Rev AA

D0000068686

Current Revision Date: 01.22.21

  1. Interventional Spine & Pain Centre. (2018). Discogenic back pain. Retrieved from: http://spinepainindore.com/conditions/discogenic-back-pain/    
  2. Alo K et al. Percutaneous lumbar discectomy: Clinical response in an initial cohort of fifty consecutive patients with chronic radicular pain. Pain Practice. 2004; 4(1):19-29.
  3. Alo K et al. Percutaneous lumbar discectomy: One-year follow-up in an initial cohort of fifty consecutive patients with chronic radicular pain. Pain Practice. 2005; 5(2):116-124.
  4. North American Spine Society. (2020). Herniated lumbar disc. Retrieved from: https://www.spine.org/KnowYourBack/Conditions/Degenerative-Conditions/Herniated-Lumbar-Disc    
  5. Miller R. (2019, April 10). Sciatica causes and exercises. Retrieved from: https://www.spine-health.com/wellness/exercise/sciatica-causes-and-exercises
  6. American Association of Neurological Surgeons. (2020). Herniated disc. Retrieved from: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Herniated-Disc 
  7. Hartl R. (2016, July 6). Lumbar herniated disc symptoms. Retrieved from: https://www.spine-health.com/conditions/herniated-disc/lumbar-herniated-disc-symptoms
  8. Mummaneni P. (2019, May 21). Discogenic low back pain. Retrieved from: https://www.spineuniverse.com/conditions/back-pain/discogenic-low-back-pain
  9. Bohinski R. (2018). Lumbar discectomy. Retrieved from: https://www.mayfieldclinic.com/pe-lumdiscectomy.htm
  10. National Spine & Pain Centers. (2020). Percutaneous discectomy: Alternative treatment for herniated discs. Retrieved from: https://www.treatingpain.com/treatments/percutaneous-discectomy/
  11. Hirsch J. (2019, March 19). Percutaneous discectomy. Retrieved from: https://www.spineuniverse.com/treatments/surgery/percutaneous-discectomy
  12. Erginousakis D et al. Comparative prospective randomized study comparing conservative treatment and percutaneous disk decompression for treatment of intervertebral disk herniation. Radiology. 2011; 260(2):487-493.
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Current revision:

D0000103435

Current Revision Date: 09.13.21

  1. Nguyen U et al. Increasing prevalence of knee pain and symptomatic knee osteoarthritis. Annals of Internal Medicine. 2011; 155(11):725-732.
  2. Peat G et al. Knee pain and osteoarthritis in older adults: A review of community burden and current use of primary health care. Annals of the Rheumatic Diseases. 2001; 60(2):91-97.
  3. Iannaccone F et al. A review of long-term pain relief after genicular nerve radiofrequency ablation in chronic knee osteoarthritis. Pain Physician. 2017; 20(3):E437-E444.
  4. El-Hakeim E et al. Fluoroscopic guided radiofrequency of genicular nerves for pain alleviation in chronic knee osteoarthritis: A single-blind randomized controlled trial. Pain Physician. 2018; 21(2):169-177.
  5. Konya Z et al. Results of genicular nerve ablation by radiofrequency in osteoarthritis-related chronic refractory knee pain. Turkish Journal of Medical Sciences. 2020; 50(1):86-95.
  6. HealthStar clinic. (2018, June 26). The 5 most common causes of knee pain. Retrieved from: https://www.healthstarclinic.com/most-common-causes-of-knee-pain/ 
  7. Sutter Health. (2021). Help for arthritic knees. Retrieved from: https://www.sutterhealth.org/services/orthopedic/non-surgical-treatment-knee-osteoarthritis 
  8. Whelan C. (2020, March 30). Everything you need to know about osteoarthritis. Retrieved from: https://www.healthline.com/health/osteoarthritis
  9. Mayo clinic. (2021, June 16). Osteoarthritis. Retrieved from: https://www.mayoclinic.org/diseases-conditions/osteoarthritis/symptoms-causes/syc-20351925
  10. Zelman D. (2021, June 14). Osteoarthritis of the knee (degenerative arthritis of the knee). Retrieved from: https://www.webmd.com/osteoarthritis/ostearthritis-of-the-knee-degenerative-arthritis-of-the-knee 
  11. Tufts Medical Center. (2021). Genicular nerve ablation. Retrieved from: https://www.tuftsmedicalcenter.org/patient-care-services/departments-and-services/physical-medicine/patient-resources/genicular-nerve-ablation   
  12. Healthline Media. (2021). 7 symptoms of arthritis in the knee. Retrieved from: https://www.healthline.com/health/osteoarthritis/knee-arthritis-symptoms#deformity 
  13. Florida Pain Medicine. (2021). Genicular nerve radiofrequency ablation. Retrieved from: https://www.floridapainmedicine.com/contents/genicular-nerve-radiofrequency-ablation
View past revisions

Current revision:

D0000258697

Current Revision Date: 05.11.23

  1. Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Höh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014. PMID: 33129427.
  2. American Cancer Society. Cancer Facts & Figures 2022. Atlanta: American Cancer Society; 2022. Retrieved from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. 
  3. Li S, Peng Y, Weinhandl ED, Blaes AH, Cetin K, Chia VM, Stryker S, Pinzone JJ, Acquavella JF, Arneson TJ. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93
  4. Kornick CA, Kramarich SS, Lamer TJ, Sitzman BT. Complications of lumbar facet radiofrequency denervation. Spine 2004; 29:1352-1354.
  5. Nath, Sherdil MD, FRCA*; Nath, Christine Ann SRN*; Pettersson, Kurt MD, PhD†. Percutaneous Lumbar Zygapophysial (Facet) Joint Neurotomy Using Radiofrequency Current, in the Management of Chronic Low Back Pain: A Randomized Double-Blind Trial. Spine: May 20, 2008 - Volume 33 - Issue 12 - p 1291-1297 doi: 10.1097/BRS.0b013e31817329f0

Bone cement: Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur beyond one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.

View past revisions

Current revision:

IVS-GSNPS-BROC-1285444

Current Revision Date: 10.16.24

  1. Stryker data on file.
  2. Noriega D, Marcia S, Theumann N, Blondel B, Simon A, Hassel F, Maestretti G, Petit A, Weidle PA, Mandly AG, Kaya JM, Touta A, Fuentes S, Pflugmacher R. A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). Spine J. 2019 Nov;19(11):1782-1795. doi: 10.1016/j.spinee.2019.07.009. Epub 2019 Jul 17. PMID: 31325625.
  3. Ong K et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials? Osteoporosis International. 2018; 29(2):375-383.
  4. Cooper C, O’Neill T, Silman A. The epidemiology of vertebral fractures. European Vertebral Osteoporosis Study Group. Bone 1993; 14(suppl 1):889-97.
  5. Pongchaiyakul C et al. Asymptomatic vertebral deformity as a major risk factor for subsequent fractures and mortality: A long-term prospective study. Journal of Bone and Mineral Research. 2005; 20(8):1349-1355.
  6. Kado D et al. Vertebral fractures and mortality in older women: A prospective study. Study of osteoporotic research group. Archives of Internal Medicine. 1999; 159(11):1215-1220.
  7. Hasserius R et al. Long-term morbidity and mortality after a clinically diagnosed vertebral fracture in the elderly – a 12 and 22-year follow-up of 257 patients. Calcified Tissue International. 2005; 76(4):235-242.
  8. Hasserius R et al. Prevalent vertebral deformities predict increased mortality and increased fracture rate in both men and women: A 10-year population-based study of 598 individuals from the Swedish cohort in the European vertebral osteoporotic study. Osteoporosis International. 2003; 14(1):61-68.
  9. Cauley J et al. Risk of mortality following clinical fractures. Osteoporosis International. 2000; 11(7):556-561.
  10. Center J et al. Mortality after all major types of osteoporotic fracture in men and women: An observational study. Lancet. 1999; 353(9156):878-882.
  11. Stanghelle B et al. Associations between health-related quality of life, physical function and pain in older women with osteoporosis and vertebral fracture. BMC Geriatrics. 2019; 19(1):298.
  12. Jung H et al. Quality of life in patients with osteoporotic vertebral compression fractures. Journal of Bone Metabolism. 2017; 24(3):187-196.
  13. Suzuki N et al. The prognosis for pain, disability, activities of daily living and quality of life after an acute osteoporotic vertebral body fracture: Its relation to fracture level, type of fracture and grade of fracture deformation. European Spine Journal. 2009; 18(1):77-88.
  14. Silverman S. The clinical consequences of vertebral compression fracture. Bone. 1992; 13(2):S27-S31.
  15. S. Food and Drug Administration, Center for Devices and Radiological Health. SpineJack Expansion Kit 510(k) Summary (K181262). Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181262.
  16. Tzermiadianos M et al. Altered disc pressure profile after an osteoporotic vertebral fracture is a risk factor for adjacent vertebral body fracture. European Spine Journal. 2008; 17:1522-1530.
View past revisions

Current revision: IVS-GSNPS-BROC-847635_REV-0_EN_US

IVS-GSNPS-BROC-847635_REV-0_EN_US

Current Revision Date: 08.18.23

  1. Abbasi D, Moore D. Osteoporotic Vertebral Compression Fracture. Orthobullets. Available at https://www.orthobullets.com/spine/2021/osteoporotic-vertebral-compression-fracture. Updated June 23, 2021; Accessed: August 18, 2023. 
  2. Edidin A et al. Morbidity and mortality after vertebral fractures: Comparison of vertebral augmentation and nonoperative management in the Medicare population.  Spine. 2015; 40(15):1228-1241. Accessed: August 18, 2023.
  3. National Osteoporosis Foundation. Osteoporosis fast facts. Retrieved from: https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed: August 18, 2023.
  4. Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2270-6; discussion 2277. doi: 10.1097/01.brs.0000142469.41565.2a. PMID: 15480139. Accessed: August 18, 2023.
  5. American Association of Neurological Surgeons. (2020). Vertebral compression fractures. Retrieved from: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Vertebral-Compression-Fractures. Accessed: August 18, 2023.
  6. Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet. 2002 May 18;359(9319):1761–7. DOI: http://dx.doi.org/10.1016/S0140-6736(02)08657-9. Accessed: August 18, 2023.
  7. Meunier PJ, Delmas PD, Eastell R, et al. Diagnosis and management of osteoporosis in postmenopausal women: clinical guidelines. International Committee for Osteoporosis Clinical Guidelines. Clin Ther. 1999 Jun;21(6):1025–44. DOI: http://dx.doi.org/10.1016/S0149-2918(99)80022-8. Accessed: August 18, 2023.
  8. Lindsay R, Burge RT, Strauss DM. One year outcomes and costs following a vertebral fracture. Osteoporos Int. 2005 Jan;16(1):78–85. DOI: http://dx.doi.org/10.1007/s00198-004-1646-x. Accessed: August 18, 2023.
View past revisions

Current revision: IVS-GSNPS-PSTR-847368_REV-0_en

IVS-GSNPS-PSTR-847368_REV-0_en

Current Revision Date: 11.09.23

  1. Kochan J. (2015, November 4). Percutaneous vertebroplasty and kyphoplasty. Retrieved from: https://emedicine.medscape.com/article/1835633-overview#a7.
  2. Clerk-Lamalice O et al. ISASS policy 2018 – Vertebral augmentation: Coverage, indications, limitations, and/or medical necessity. International Journal of Spine Surgery. 2019; 13(1):1-10.
  3. Beall DP, Chambers MR, Thomas S, et al. Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures: The EVOLVE Trial. Neurosurgery. 2019;84(1):169-178. doi:10.1093/neuros/nyy017
  4. Highsmith J. (2019, May 15). Benefits of balloon kyphoplasty. Retrieved from: https://www.spineuniverse.com/resource-center/spinal-fractures/benefits-balloon-kyphoplasty
View past revisions

Current revision: IVS-IVAS-BROC-846502_REV-0

IVS-IVAS-BROC-846502_REV-0

Current Revision Date: 12.11.23

  1. Kochan J. (2015, November 4). Percutaneous vertebroplasty and kyphoplasty. Retrieved from: https://emedicine.medscape.com/article/1835633-overview#a7.
  2. Driver C and Shiel W. (2020, February 26). Osteoporosis and calcium. Retrieved from: https://www.emedicinehealth.com/osteoporosis_and_calcium/article_em.htm
  3. Alexandru D and So W. Evaluation and management of vertebral compression fractures. Permanente Journal. 2012; 16(4):46-51.
  4. Clerk-Lamalice O et al. ISASS policy 2018 – Vertebral augmentation: Coverage, indications, limitations, and/or medical necessity. International Journal of Spine Surgery. 2019; 13(1):1-10.
  5. Highsmith J. (2019, May 15). Benefits of balloon kyphoplasty. Retrieved from: https://www.spineuniverse.com/resource-center/spinal-fractures/benefits-balloon-kyphoplasty
  6. Langdon J et al. Vertebral compression fractures – new clinical signs to aid diagnosis. Annals of the Royal College of Surgeons of England. 2010; 92(2):163-166.
  7. Wong C and McGirt M. Vertebral compression fractures: A review of current management and multimodal therapy. Journal of Multidisciplinary Healthcare. 2013; 6:205-214.
  8. Levin R. (2018, October 17). Kyphoplasty procedure overview. Retrieved from: https://www.spine-health.com/treatment/back-surgery/kyphoplasty-procedure-overview
  9. Highsmith J. (2019, May 15). How balloon kyphoplasty works. Retrieved from: https://www.spineuniverse.com/resource-center/spinal-fractures/how-balloon-kyphoplasty-works
  10. Beall D. (2020). Vertebral augmentation: The comprehensive guide to vertebroplasty, kyphoplasty, and implant augmentation. Thieme Publishers New York.
View past revisions

Current revision: IVS-MILD-BROC-1436100_REV-2

IVS-MILD-BROC-1436100_REV-2

Current Revision Date: 03.12.25

  1. Stryker data on file.
  2. Mekhail N, et al. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up. Pain Pract. 2021 Nov;21(8):826-835 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291913/.
  3. Staats PS, Chafin TB, Golovac S, et al. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43(7):789-794. doi:10.1097/AAP.0000000000000868.
  4. Deer TR, Chafin TB, Costandi SJ, et al. The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis. Pain Pract. 2024;24(1):109-119. doi:10.1111/papr.13293.
  5. Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012 Jul;12(6):417-25. doi: 10.1111/j.1533-2500.2012.00565.x. Epub 2012 Jun 1. PMID: 22651852. https://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2012.00565.x
  6. Wu L, Munakomi S, Cruz R. Lumbar Spinal Stenosis. [Updated 2024 Jan 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531493/.
  7. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009 May;18(5):679-86. doi: 10.1007/s00586-009-0919-7. Epub 2009 Mar 11. PMID: 19277726; PMCID: PMC3234003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234003/
  8. Jain S, Deer T, Sayed D, Chopra P, Wahezi S, Jassal N, Weisbein J, Jameson J, Malinowski M, Golovac S. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020 Sep;10(5):331-348. doi: 10.2217/pmt-2020-0037. Epub 2020 Jul 1. PMID: 32609052. https://www.tandfonline.com/doi/full/10.2217/pmt-2020-0037#d1e525.
  9. Deer T, Kim C, Wahezi SE, Qu H, Sayed D; MOTION Study Investigators. Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial. J Pain Res. 2021 Jun 10;14:1687-1697. doi: 10.2147/JPR.S312573. PMID: 34140805; PMCID: PMC8203201. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203201/.
  10. Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38. PMID: 26815247. https://www.painphysicianjournal.com/current/pdf?article=MjUxNA%3D%3D&journal=94.
View past revisions

Current revision: IVS-MILD-BROC-1436137_REV-2

IVS-MILD-BROC-1436137_REV-2

Current Revision Date: 08.26.25

  1. Stryker data on file.
  2. Mekhail N, et al. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up. Pain Pract. 2021 Nov;21(8):826-835 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291913/.
  3. Wu L, Munakomi S, Cruz R. Lumbar Spinal Stenosis. [Updated 2024 Jan 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531493/.
  4. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009 May;18(5):679-86. doi: 10.1007/s00586-009-0919-7. Epub 2009 Mar 11. PMID: 19277726; PMCID: PMC3234003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234003.
  5. Jain S, Deer T, Sayed D, Chopra P, Wahezi S, Jassal N, Weisbein J, Jameson J, Malinowski M, Golovac S. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020 Sep;10(5):331-348. doi: 10.2217/pmt-2020-0037. Epub 2020 Jul 1. PMID: 32609052. https://www.tandfonline.com/doi/full/10.2217/pmt-2020-0037#d1e525.
  6. Deer T, Kim C, Wahezi SE, Qu H, Sayed D; MOTION Study Investigators. Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial. J Pain Res. 2021 Jun 10;14:1687-1697. doi: 10.2147/JPR.S312573. PMID: 34140805; PMCID: PMC8203201. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203201/.
  7. Staats PS, Chafin TB, Golovac S, et al. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43(7):789-794. doi:10.1097/AAP.0000000000000868.
  8. Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38. PMID: 26815247. https://www.painphysicianjournal.com/current/pdf?article=MjUxNA%3D%3D&journal=94.
  9. Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012 Jul;12(6):417-25. doi: 10.1111/j.1533-2500.2012.00565.x. Epub 2012 Jun 1. PMID: 22651852. https://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2012.00565.x.
  10. Deer TR, Chafin TB, Costandi SJ, et al. The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis. Pain Pract. 2024;24(1):109-119. doi:10.1111/papr.13293.
  11. National Coverage Determination (NCD) for Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (150.13). Accessed 4/4/25. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=358.
View past revisions

Current revision: IVS-MILD-PSTR-1617037_REV-1

IVS-MILD-PSTR-1617037_REV-1

Current Revision Date: 08.26.25

  1. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009 May;18(5):679-86. doi: 10.1007/s00586-009-0919-7. Epub 2009 Mar 11. PMID: 19277726; PMCID: PMC3234003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234003/.
  2. Jain S, Deer T, Sayed D, Chopra P, Wahezi S, Jassal N, Weisbein J, Jameson J, Malinowski M, Golovac S. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020 Sep;10(5):331-348. doi: 10.2217/pmt-2020-0037. Epub 2020 Jul 1. PMID: 32609052. https://www.tandfonline.com/doi/full/10.2217/pmt-2020-0037#d1e525.
  3. Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868. PMID: 30199512; PMCID: PMC6319572. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319572/.
  4. Stryker data on file.
  5. Deer T, Kim C, Wahezi SE, Qu H, Sayed D; MOTION Study Investigators. Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial. J Pain Res. 2021 Jun 10;14:1687-1697. doi: 10.2147/JPR.S312573. PMID: 34140805; PMCID: PMC8203201. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203201/.
View past revisions

Current revision: IVS-MILD-PTED-1617000_REV-1

IVS-MILD-PTED-1617000_REV-1

Current Revision Date: 08.14.25

  1. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009 May;18(5):679-86. doi: 10.1007/s00586-009-0919-7. Epub 2009 Mar 11. PMID: 19277726; PMCID: PMC3234003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234003/.
  2. Jain S, Deer T, Sayed D, Chopra P, Wahezi S, Jassal N, Weisbein J, Jameson J, Malinowski M, Golovac S. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020 Sep;10(5):331-348. doi: 10.2217/pmt-2020-0037. Epub 2020 Jul 1. PMID: 32609052. https://www.tandfonline.com/doi/full/10.2217/pmt-2020-0037#d1e525.
  3. Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868. PMID: 30199512; PMCID: PMC6319572. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319572/.
  4. Stryker data on file.
  5. Deer T, Kim C, Wahezi SE, Qu H, Sayed D; MOTION Study Investigators. Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial. J Pain Res. 2021 Jun 10;14:1687-1697. doi: 10.2147/JPR.S312573. PMID: 34140805; PMCID: PMC8203201. https://pmc.ncbi.nlm.nih.gov/articles/PMC8203201/.
View past revisions

Current revision:

IVS-MILD-STUD-1476551_REV-0

Current Revision Date: 11.26.24

  1. Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009 May;18(5):679-86. doi: 10.1007/s00586-009-0919-7. Epub 2009 Mar 11. PMID: 19277726; PMCID: PMC3234003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234003/.
  2. Staats PS, Chafin TB, Golovac S, et al. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43(7):789-794. doi:10.1097/AAP.0000000000000868.
  3. Deer TR, Chafin TB, Costandi SJ, et al. The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis. Pain Pract. 2024;24(1):109-119. doi:10.1111/papr.13293.
  4. Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up. Pain Pract. 2021;21(8):826-835. doi:10.1111/papr.13020.
  5. Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012 Jul;12(6):417-25. doi: 10.1111/j.1533-2500.2012.00565.x. Epub 2012 Jun 1. PMID: 22651852. https://onlinelibrary.wiley.com/doi/10.1111/j.1533-2500.2012.00565.x.
  6. Jain S, Deer T, Sayed D, Chopra P, Wahezi S, Jassal N, Weisbein J, Jameson J, Malinowski M, Golovac S. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020 Sep;10(5):331-348. doi: 10.2217/pmt-2020-0037. Epub 2020 Jul 1. PMID: 32609052. https://www.tandfonline.com/doi/full/10.2217/pmt-2020-0037#d1e525.
  7. Deer T, Kim C, Wahezi SE, Qu H, Sayed D; MOTION Study Investigators. Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial. J Pain Res. 2021 Jun 10;14:1687-1697. doi: 10.2147/JPR.S312573. PMID: 34140805; PMCID: PMC8203201. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203201/.
  8. Pryzbylkowski, P., Bux, A., Chandwani, K., Khemlani, V., Puri, S., Rosenberg, J., & Sukumaran, H. (2021). Understanding Whether Chronic Lower back Pain Patients with Lumbar Spinal Stenosis Benefit from Multiple Epidural Steroid Injections Prior to the Mild® Procedure. Pain Management, 12(3), 261–266. https://doi.org/10.2217/pmt-2021-0093.
  9. Udeh BL, CostandiS , DaltonJE , GhoshR , YousefH , MekhailN. The 2-year cost-effectiveness of 3 options to treat lumbar spinal stenosis patients. Pain Pract.15(2), 107–116 (2015).
  10. Deer TR, Grider JS, Pope JE, et al. Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325-1354. Published 2022 May 5. doi:10.2147/JPR.S355285.
View past revisions

Current revision: IVS-OPTA-PTED-1668702_REV-0

IVS-OPTA-PTED-1668702_REV-0

Current Revision Date: 03.12.25

  1. Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Höh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014. PMID: 33129427.
  2. Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Complications of lumbar facet radiofrequency denervation. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1352-4. doi: 10.1097/01.brs.0000128263.67291.a0. PMID: 15187637.
  3. Nath S, Nath CA, Pettersson K. Percutaneous lumbar zygapophysial (Facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double-blind trial. Spine (Phila Pa 1976). 2008 May 20;33(12):1291-7; discussion 1298. doi: 10.1097/BRS.0b013e31817329f0. PMID: 18496338.
  4. Cleveland Clinic. 2023. Radiofrequency Ablation for Pain Management. Available at: https://my.clevelandclinic.org/health/treatments/17411-radiofrequency-ablation#:~:text=Don't%20drive%20or%20do,site%20for%20a%20few%20days [Assessed January 25th 2023].
  5. American Cancer Society. Cancer Facts & Figures 2022 [Internet]. Atlanta: American Cancer Society; 2022. Available from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf.
  6. Li S, Peng Y, Weinhandl ED, Blaes AH, Cetin K, Chia VM, Stryker S, Pinzone JJ, Acquavella JF, Arneson TJ. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93. doi: 10.2147/CLEP.S28339. Epub 2012 Apr 10. PMID: 22570568; PMCID: PMC3345874.
  7. Ziu E, Viswanathan VK, Mesfin FB. Spinal Metastasis. [Updated 2023 Aug 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441950/.
View past revisions

Current revision:

IVS-OPTABVN-BROC-1619388_REV-0

Current Revision Date: 05.07.25

  1. Nwosu M, Agyeman WY, Bisht A, Gopinath A, Cheema AH, Chaludiya K, Khalid M, Yu AK. The Effectiveness of Intraosseous Basivertebral Nerve Ablation in the Treatment of Nonradiating Vertebrogenic Pain: A Systematic Review. Cureus. 2023 Apr 4;15(4):e37114. doi: 10.7759/cureus.37114. PMID: 37034146; PMCID: PMC10075185.
  2. Tieppo Francio V, Sayed D. Basivertebral Nerve Ablation. [Updated 2023 May 22]. In: StatPearls [Internet]. Treasure Island (FL): Stat Pearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK572127/.
  3. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25. PMID: 32451777.
  4. Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S; INTRACEPT Trial Investigators. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results. N Am Spine Soc J. 2021 Oct 26;8:100089. doi: 10.1016/j.xnsj.2021.100089. PMID: 35141653; PMCID: PMC8820067.
  5. Smuck M, Truumees E, Macadaeg K, Pena E, Arbuckle J 2nd, Gentile J 2nd, Funk R, Singh D, Vinayek S. Intraosseous basivertebral nerve ablation: Pooled long-term outcomes from two prospective studies. Interventional Pain Medicine. 2023;2(2):100088. doi: 10.1016/j.inpm.2023.100088. *Date accessed 3/20/25.

Bone cement: Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur beyond one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.

View past revisions

Current revision: Rev None

IVS-SJ-PSTR-871689

Current Revision Date: 08.14.24

  1. Beaumont. (2021). Back, spine, and neck mobility. Retrieved from: https://www.beaumont.org/conditions/back-spine-and-neck-mobility.
  2. Noriega D et al. A prospective, international, randomized, non-inferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study). The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.07.009.

The information presented is for educational purposes only. Please speak with your doctor to decide what course of treatment is right for you. Only your doctor can make the medical judgment regarding which products and treatment is right for you. Any medical procedure carries certain risks and your doctor will explain all possible complications and/or side effects. Not all patients will experience the same results.

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