technology and outcomes - lmt surgical · idata (eutra17 report, issued jan 2018). 2. ......
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TECHNOLOGY AND OUTCOMES
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Growth factors
Osteoconductive scaffolds
Osteogenic cells
Mechanical environment
EXOGEN complements surgical intervention Four factors contribute to the process of bone restoration.2 These form the Diamond Model of bone healing. Any deficit of the four factors alters the physiological sequence of fracture healing and predisposes to complications.2
Fracture healing managed through surgical intervention
Bone healing stimulated through EXOGEN’s mechanism of action
The Diamond Model2
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
EXOGEN Treatment Pathways
References and Indications
EXOGEN sends ultrasound through soft tissue to the fracture site, resulting in nanomotion of osteoblasts.
Integrins cluster on the cell surface, triggering a biological cascade inculding:
• Greater expression of COX-27
• Greater production of PGE2
Cell stimulus leads to clinical responses:
• Increased number of osteoblasts3-5 through conversion of stem cells
• Improved blood supply3,6 resulting from stimulation of VEGF
• New bone formation7,8 by increased levels of BMP’s (-2, -4, -6 and -7)
• Enhanced mineralization3,10
EXOGEN promotes bone healing by stimulating biological processes9
Nanomotion at the Fracture Site
Detection by Integrins
Reaction of CellsFocal Adhesion
Beam is for illustrative purposes only. Actual beam size is 45 mm wide and penetrates soft tissue at a depth of more than 250 mm.11
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
EXOGEN Treatment Pathways
References and Indications
Risk factors and bone healing
While most fractures heal uneventfully, fracture-healing complications such as delayed union, nonunion, and malunion do occur.12
• Nonunion rate in long bones: 5%-10%13
• Nonunion rate in tibial shaft fractures: 10%-20%12
• Nonunion rate in foot and ankle fusions: ± 12%14
Several risk factors may affect bone healing:12-14
• Fracture-related factors: - Open fracture - High-energy trauma - Multiple fractures
• Patient-related factors: - Diabetes - Smoking - Chronic opiod use - Osteoporosis - Osteoarthritis +/- rheumatoid arthritis - Anticoagulant prescription
EXOGEN helps to mitigate patient-related risk factors.
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
Diabetes
Smoking
EXOGEN Treatment Pathways
References and Indications
Risk factors and bone healing - diabetes
Diabetics:6
• are known to have compromised healing in both soft tissue and bone. • showed 63% slower time to heal than normal in closed fractures. • 87% slower fracture healing in cases that required open reduction.
EXOGEN mitigates the effects of diabetes:
Diabetes: The problems6 EXOGEN: The benefits
Electrolyte and endocrine imbalances
Vascular insufficiency and microvascular pathology*
Compromised immune responses and infection
Not Applicable
Improved bloodsupply (angiogenesis); ± 100-fold increase in VEGF3,6
Non-invasive treatment; no risk of post surgical infections
*Diabetic rats produced substantially lower levels of VEGF and healed more slowly compared to nondiabetic controls6
EXOGEN heal rates in diabetics:
Heal rates All Diabetics
Zura16† 96.2% 95.3%
Post-market Data 84.4% 84.2%
†Study of fresh fracture heal rates
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
Diabetes
Smoking
EXOGEN Treatment Pathways
References and Indications
Risk factors and bone healing - smoking
Smokers:15
• are 3 times more likely to have impaired bone healing. • are 6-fold more likely to develop deep infections after surgery. • were significantly more likely to develop delayed and nonunions (p=0.0007) in tibial shaft fracture patients.
EXOGEN mitigates the effects of smoking:
Smoking: The problems17
Impaired perfusion of the extremities (due to chronic vasoconstriction associated with nicotine)
Inhibition of osteoblast differentiation
Higher risk of developing deep infections post-surgery (6-fold higher risk)
EXOGEN: The benefits
Improved blood-supply (angiogenesis); ± 100-fold increase in VEGF3,6
Promotes conversion of stem cells to osteoblasts3-5
Non-invasive treatment; no risk of post surgical infections
EXOGEN accelerates healing in smokers:17
EXOGEN heal rates in smokers:
Heal rates All SmokersZura16* 96.2% 94.9%Gebauer18 85.0% 79.2%Scaphoid nonunions19 92.0% 100.0%
*Study of fresh fracture heal rates
Tibi
al fr
actu
res
175 days +/- 27.0
103 days +/- 8.3
EXOGEN Control
n = 7
n = 14
p < 0.006
% faster58
Values are mean +/- standard error
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
Diabetes
Smoking
EXOGEN Treatment Pathways
References and Indications
EXOGEN Treatment Pathways
EXOGEN complements surgical intervention.
Initial treatment
Surgery
Acute Fracture Follow Up
My patient is not progressing
as expected. What can I do?
Consider EXOGEN as an alternative treatment to stimulate bone biology.
Consider EXOGEN as an adjunctive treatment to stimulate bone biology.
Healing uncertain
Healed
EXOGEN offers a safe, noninvasive treatment with equivalent heal rates to surgery.
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
EXOGEN Treatment Pathways
References and Indications
References and Indications
References: 1. iData (EUTRA17 report, issued Jan 2018). 2. Giannoudis PV, Einhorn TA, March D. Fracture healing: The diamond concept. Injury, Int.J.Care Injured. 2007:38S4;S3-S6. 3. Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells. Clin Orthop Relat Res. 2004;418:253-9.4. Lai CH, Chen SC, Chiu LH, et al. Effects of low-intensity pulsed ultrasound, dexamethasone/TGF-ß1 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):1022-33.5. Ebisawa K, Hata K, Okada K, et al. Ultrasound enhances transforming growth factor β-mediated Chondrocyte differentiation of human mesenchymal stem cells. Tissue Engineering.
2004; 10(5-6); 921-929.6. Coords M, Breitbart E, Paglia D, et al. The effects of low-intensity pulsed ultrasound upon diabetic fracture healing. J Orthop Res. 2011;29(2):181-8.7. Naruse K, Sekiya H, Harada Y, et al. Prolonged endochondral bone healing in senescence is shortened by low-intensity pulsed ultrasound in a manner dependent on COX-2.
Ultrasound Med Biol. 2010;36(7):1098-108.8. 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;23(3):646-52.9. Harrison A, Lin S, Pounder N, Mikuni-Takagaki Y. Mode & mechanism of low intensity pulsed ultrasound (LIPUS) in fracture repair. Ultrasonics. 2016:70;45–52. 10. 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(1):229. doi: 10.1186/1471-2474-11-229.11. Data on file. RPT-00036812. Hermandez RK, Do TP, Critchlow CW, Dent RE. Patient-related risk factors for fracture-healing complications in the United Kingdom General Practice Research Database. Acta
Orthopeadica. 2012;83 (6):653-660. 13. Zura R, Mehta S, Della Rocca GJ, Steen RG. Biological risk factors for nonunion of bone fracture. JBJS Reviews. 2016;4(1):1-1214. Thevedran G, Shah K, Pinney SJ, Younger AS. Perceived risk factors for nonunion following foot and ankle arthrodesis. J of Orthopedic Surgery. 2017;25(I):1-6. 15. Della Rocca G, Brodie C, Harrison A. The impact of Low-Intensity Pulsed Ultrasound (LIPUS) on Risk Factors for Fracture Nonunion. ORS Connect. 2018:xxx16. Zura R, Mehta S, Della Rocca GJ, Jones J. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC
Muscoskeletal Disorders. 2015;16:1-10. 17. 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 Relat Res. 1997; 337:
198-207.18. Gebauer D, Mayr E, Orthner E, RyabyJ P. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med Biol. 005;31(10):1391−1402.19. Data on file. RPT-00039020. Data on file. RPT-000351
Summary of Indications for Use: EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,† stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.†A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have 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.
Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC. © 2018 Bioventus LLC. All rights reserved. SMK-002623 10/18
EXOGEN Complements Surgical Intervention
EXOGEN Promotes Bone Healing
Risk Factors and Bone Healing
EXOGEN Treatment Pathways
References and Indications