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VCF competitive comparison guide

D0000023001

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

 

Rev None

Revision Date: 12.07.17

  1. "Vertebral Compression Fractures." AANS. N.p., n.d. Web. 20 July 2017. http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Vertebral-Compression-Fractures.
  2. 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. N.p., 07 Feb. 2014. Web. 21 July 2017. 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.
  3. AMG Research. "VCF Stryker Branding and Technology Study." PA, Pittsburgh. 7 Mar. 2017. Powerpoint Presentation.
  4. http://www.medtronic.com/content/dam/medtronic-com/products/spinal-orthopaedic/vertebroplasty/kyphon-interventional-product-catalog-201608691EN.pdf
  5. Medtronic IFU: HV-R,
  6. Medtronic IFU: Xpede,
  7. Medtronic IFU: ActivOs
  8. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1774410
  9. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle_Print&ID=1774266
  10. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1968895
  11. "MAUDE Adverse Event Report: MEDTRONIC, INC. KYPHON EXPRESS CURETTE CURETTE, VERTEBROPLASTY." Accessdata.fda.gov. N.p., n.d. Web. 30 June 2017.
  12. https://patents.google.com/patent/US6248110B1/en
  13. Theuer, K.A. "In-Vitro Bioactivity and Physical Properties of Materials for Vertebral Augmentation." Stryker (n.d.): n. pag. Web.
  14. Bae, Hyun, and Et Al. "A Prospective Randomized FDA-IDE Trial Comparing Cortoss With PMMA for Vertebroplasty." Spine 37.7 (2012): 544-50. Web.
  15. https://www.merit.com/wp-content/uploads/2017/03/401803001_A.StabiliT-System-Brochure.6_panel.web_.pdf
  16. https://www.merit.com/wp-content/uploads/2017/03/402534001-B-StabiliTMX.pdf
  17. https://www.merit.com/interventional-oncology-spine/vertebral-compression-fracture/vcf/stabiliit-vp-vertebral-augmentation-system/#tab-id-2
  18. StabiliT Vertebral Augmentation System IFU
  19. https://www.merit.com/wp-content/uploads/2017/07/403580001-A.pdf
  20. https://www.merit.com/interventional-oncology-spine/vertebral-compression-fracture/vcf/osseoflex-bone-cement-delivery-system/
  21. Osseoperm IFU.
  22. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1799442
  23. https://www.depuysynthes.com/hcp/spine/procedures/qs/vertebral-body-augmentation
  24. Confidence IFU
  25. http://www.panmed.us/about.php
  26. http://www.globusmedical.com/algeatherapies/
  27. Globus Maude: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5450350&pc=FSH
  28. "Kiva VCF Treatment System." Benvenue Medical. N.p., n.d. Web. 14 July 2017. https://benvenuemedical.com/products/kiva/.
  29. Beall, Doug et al. "Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data." Pain Physician 18 (2015): 299-306. Web.