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","roles":{"textData":{}}},{"id":"Text_Caption_M10_666","class":"TODO::Senthil","instance":"Text_Caption_M10_666","title":"       When treating your patients, what’s most important to you?      ","roles":{"textData":{}}},{"id":"Text_Caption_M10_662","class":"TODO::Senthil","instance":"Text_Caption_M10_662","title":"The cost of an implantable stimulator may be higher than other available treatment options, however, the OsteoGen is not for every patient and certainly not appropriate for every long-bone nonunion case. ","roles":{"textData":{}}},{"id":"Text_Caption_M10_488","class":"TODO::Senthil","instance":"Text_Caption_M10_488","title":"         In cases where you a have a patient that has been suffering for a long time, is eager to feel better, ","roles":{"textData":{}}},{"id":"Text_Caption_M10_924","class":"TODO::Senthil","instance":"Text_Caption_M10_924","title":"and will do whatever it takes to heal normally, OsteoGen may be a good option. 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","roles":{"textData":{}}},{"id":"Notepad_Image_M10_650","class":"TODO::Senthil","instance":"Notepad_Image_M10_650","roles":{"click":{"subtype":"button"},"textData":{}}},{"id":"Text_Caption_M10_503","class":"TODO::Senthil","instance":"Text_Caption_M10_503","title":"Doctor, thank you for being candid with me to bring up this valid concern. If I were you and/or your patient, and I learned that utilizing this device required an additional surgery, I may be concerned too, so I’m happy you brought this up so we can discuss the requirements and options you and/or your patients have.     ","roles":{"textData":{}}},{"id":"Text_Caption_M10_504","class":"TODO::Senthil","instance":"Text_Caption_M10_504","title":"Before doing so, can you help me understand where this concern may be coming from?        ","roles":{"textData":{}}},{"id":"Text_Caption_M10_673","class":"TODO::Senthil","instance":"Text_Caption_M10_673","title":"     What has been your experience with implanting and explanting stimulators?      ","roles":{"textData":{}}},{"id":"Text_Caption_M10_927","class":"TODO::Senthil","instance":"Text_Caption_M10_927","title":"         What’s most important to you when prescribing a bone stim?      ","roles":{"textData":{}}},{"id":"Text_Caption_M10_928","class":"TODO::Senthil","instance":"Text_Caption_M10_928","title":"If after various clarifying questions you determine the objection is a true concern, you may respond with something like this:   ","roles":{"textData":{}}},{"id":"Text_Caption_M10_930","class":"TODO::Senthil","instance":"Text_Caption_M10_930","title":"      It’s important to understand the removal of the generator after 24 weeks is completely optional. 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Effect of faradic products on direct current-stimulated calvarial organ culture calcium levels. Biochem Biophys Res Comm. 1999 (264): 657-661. Paterson DC, Lewis GN, Cass CA. Treatment of delayed union and nonunion with an implanted direct current stimulator. Clin Orthop Relat Res. 1980 (148) may:117-128. Dunn AW, Rush GA. Electrical stimulation in treatment of delayed union and nonunion of fractures and osteotomies. Southern Medical Journal. 1984;77 (12):1530-1534. PJ Cundy, FRACS, DC Paterson, MD, FRCS, FRACS. A Ten Year Review of Treatment of Delayed Union and Nonunion with an Implanted Bone Growth Stimulator. Clin Orthop Relat Res. 1990 Oct; (259): 216-22. 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The time of injury to implantation was 3 months to 7.5 years which corresponds to the current definition of a nonunion i.e., a nonunion is considered to be established when there are no visibly progressive signs of healing. While osteotomy nonunions and pediatric use are not contraindicated, OsteoGen Stimulators do not have an approved indication to treat osteotomy nonunions or pediatric patients. The Osteostim S12 manufactured by Telectronics Pty. Ltd., Sydney, Australia utilized in the study was the predecessor to the EBI OsteoGen Surgically Implanted Bone Growth Stimulator.  †The original 1980 PMA included two clinical studies; neither was designed for long-term follow-up. In the first study (N=30) the patients were followed for a minimum of ten (10) years, with an overall follow-up rate of 48.2%. The long-term success rate was 66.7%. This calculation excludes the initial treatment successes not followed for ten (10) years (N=11). The second study (N=107) followed the patients for a minimum of four (4) years with overall follow-up rate of 25.6%. The long-term success rate was 38.8%. This calculation excludes the initial treatment successes not followed for four (4) years (N=58). In both studies, patients had difficult nonunion fractures: 0.7 and 1.5 number of average prior surgeries, average 28.4 and 24.3 months (median 24 and 16) disability since original injury, and 43.3% and 24.3% infected prior to treatment, respectively.  ◊ While osteotomy nonunions are not contraindicated, OsteoGen Stimulators do not have an approved indication to treat osteotomy nonunions. All nonunions that had concomitant bone grafting healed with one exception, a synovial pseudarthrosis. Two other pseudarthrosis healed within two to three months respectively. Only one of three stimulators implanted without bone grafting produced union.   Δ While osteotomy nonunions are not contraindicated, OsteoGen Stimulators do not have an approved indication to treat osteotomy nonunions. The time of injury from initial surgery to implantation for the long-term review was less than 9 months to greater than 18 months which corresponds to the current definition of a nonunion i.e., a nonunion is considered to be established when there are no visibly progressive signs of healing.  **Although not indicative of human clinical results, outcomes from pre-clinical research have been implicated in various models of bone repair.  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