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SpineJack System Launch Slick

IVS-GSNPS-BROC-1285444

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.