References

  1. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703.
  2. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.
  3. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001;16(4):671-680.
  4. Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells. Clin Orthop Rel Res. 2004;418:253-259.
  5. Ebisawa et al. Tissue engineering 5/6 2004 & Mukai et al., Ultrasound Med & Biol. 2005;31(12).
  6. Kokubu T, Matsui N, Fujioka H, Tsunoda M, Mizuno K. Low intensity pulsed ultrasound exposure increases prostaglandin E2 production via the induction of cyclooxygenase-2 mRNA in mouse osteoblasts. Biochem Biophys Res Comm. 1999;256:284–287.
  7. Sena K, Leven RM, Mazhar K, Sumner DR, Virdi AS. Early gene response to low-intensity pulsed ultrasound in rat osteoblastic cells. Ultrasound Med & Biol. 2005;31:703-708.
  8. Lai C, et al. Effects of low-intensity pulsed ultrasound, dexamethasone/TGF-β1 and/or BMP-2 on the transcriptional expression of genes in human mesenchymal stem cells: chondrogenic vs. osteogenic differentiation. Ultrasound Med & Biol. 2010;36(6):1022-33.
  9. Freeman T, Patel P, Parvizi J, Antoci V Jr, Shapiro IM. Micro-CT analysis with multiple thresholds allows detection of bone formation and resorption during ultrasound treated fracture healing. J Orthop Res. 2009;27(5):673-779. doi: 10.1002/jor.20771.
  10. Based on a mathematical simulation through soft tissue; Data on File at Smith & Nephew.
  11. Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Rel Res. 1997;337:198-207.
  12. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.
  13. Data on file: 12000.01.
  14. Highest rate of healing reported among pre-market approval submissions to FDA based on variable fracture types, sites and conditions. See EXOGEN – PMA 900009 – 10/05/1994, EXOGEN – PMA 900009, Supplement – 02/23/2000, Bioelectron – PMA P850022 – 02/18/1986, EBI – PMA P790002 – 11/06/1979, Orthofix/AME – PMA P850007 – 02/21/1986, Orthologic – PMA P910066 – 03/04/1994, EBI – PMA P790005 – 01/25/1980.
  15. Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229.
  16. Gebauer D, Mayr E, Orthner E, Ryaby JP. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med & Biol. 2005;31(10):1391-402.
  17. de Ana FJ. Internal Report (2007). Data on file. Smith & Nephew.
  18. Premarket Approval P900009/Supplement 6. Smith & Nephew.
  19. Simulation of ultrasound transmission for the human-femur model. Internal Report (2005). Teijin Pharma Ltd.
  20. Lotsova EI. Effect of ultrasound on the strength of metal fixing pins for fractures and joint injuries. Mechanics of Composite Materials. 1979;15:330.5
  21. Gersten JW. Effect of metallic objects on temperature rises produced in tissues by ultrasound. Amer J Phys Med. 1988;37:75-82.
  22. Lehman JF, Brunne GD, Martinis AJ, McMillan JA. Ultrasonic effects as demonstrated in live pigs with surgical metallic implants. Arch Phys Med Rehabil. 1979;40:483-488.
  23. Aaron RK, Ciombor DM, Bruce J. Treatment of nonunions with electric and electromagnetic fields.  Clin Orthop Relat Res. 2004;419:21-29.
  24. Heckman JD, Sarasohn-Kahn J. The economics of treating tibia fractures. The cost of delayed unions. Bull Hosp Jt Dis. 1997;56(1):63-72.
  25. Agency for Healthcare Research and Quality. ICD-9-CM principal diagnosis code 733.82, Nonunion Of Fracture. HCUPnet. http://hcupnet.ahrq.gov/HCUPnet.jsp. Accessed Dec. 30, 2010.
  26. Schultz M, Oremus M, Whitman CS, Conway JD. Cost-effectiveness of bone stimulators in the conservative treatment of stable non-union fractures. International Society for Pharmacoeconomics and Outcomes Research, Seventh Annual European Congress, Hamburg, Germany, Oct. 24-26, 2004.
  27. EXOGEN [package insert]. Memphis, TN: Smith & Nephew; 2011.
  28. Zhou S, Bachem MG, Seufferlein T, Li Y, Gross HJ, Schmelz A. Low intensity pulsed ultrasound accelerates macrophage phagocytosis by a pathway that requires actin polymerization, Rho, and Src/MAPKs activity. Cell Signal. 2008 Apr;20(4):695-704. Epub 2007 Dec 14.
  29. Sant'Anna EF, Leven RM, Virdi AS, Sumner DR. Effect of low intensity pulsed ultrasound and BMP-2 on rat bone marrow stromal cell gene expression. J Orthop Res. 2005 May;23(3):646-52.
  30. Tang CH, Lu DY, Tan TW, Fu WM, Yang RS. Ultrasound induces hypoxia-inducible factor-1 activation and inducible nitric-oxide synthase expression through the integrin/integrin-linked kinase/Akt/mammalian target of rapamycin pathway in osteoblasts. J Biol Chem. 2007 Aug 31;282(35):25406-15. Epub 2007 Jun 21.
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*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions† excluding skull and vertebra.

In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.

There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080.

†A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

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Smith & Nephew: EXOGEN(TM) Bone Healing System