Surgically implanted bone growth stimulator
The OsteoGen surgically implanted bone growth stimulator is a useful adjunct for treating nonunions where surgery is already planned or where patient noncompliance may be a factor with pulsed electromagnetic fields (PEMF). Because the OsteoGen is totally implanted, your patient is assured of the therapeutic treatment at the nonunion site.
30cm long lead option allows positioning of generator in areas more suitable for placement.
*MRI safety information has not yet been established for OsteoGen Implantable Bone Growth Stimulators. The FDA approved device trade name is the EBI OsteoGen Implantable Growth Stimulator.
INDICATIONS AND USAGE
The Stimulator is indicated in the treatment of long bone nonunions. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. 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.
There are no known contraindications to the use of this device, however, due to insufficient clinical experience, it is not recommended that it be used in the following conditions: pathological fractures due to malignant tumors or in the presence of active osteomyelitis.