APMA News - January 2015 - (Page BB1)
360o of pemf treatment to heal
challenging nonunions
1-3
Orthofix Osteogenesis Stimulators provide a safe and effective
non-surgical treatment to improve fracture healing. Physio-Stim's
PEMF (pulsed electromagnetic field) signal induces an electrical
field at the fracture site which stimulates fracture repair.*
, 4-6
Proven Fracture Healing Success 7
Fibula:
91.4%
Tibia:
89.0%
Metatarsal: 90.9%
Brief Prescribing Information:
Physio-Stim®
The Physio-Stim® is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion
defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Use of this device is contraindicated where the individual has synovial pseudarthrosis. Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic
fields. The safety and effectiveness of this device has not been established for individuals lacking skeletal maturity or individuals with a nonunion secondary to, or in connection with,
a pathological condition. The safety of this device for use on patients who are pregnant or nursing has not been established. Rare instances of reversible minor discomfort have been reported.
Full prescribing information can be found in product labeling on our patient education website www.bonestimulation.com or by calling Patient Services at 1-800-535-4492.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
* The results of preclinical studies may not be indicative of human clinical trials.
1. PMA P850007. February 1986. 2. Garland DE, Moses B, Salver W. Fracture healing: Long-term follow-up of fracture nonunions treated with PEMFs. Contemp Orthop. 1991;22(3):295-302
3. Data on file. Field mapping analysis conducted by M. Zborowski, Ph.D., Cleveland Clinic. 4. Marino, AA and Becker, RO: Piezoelectric effect and growth control in bone. Nature. 1970 October;
228: 473-74 5. McElhaney, JH: The charge distribution on the human femur due to load. J Bone Joint Surg Am. 1967; 49(8): 1561-71 6. Midura RJ, Ibiwoye MO, Powell, KA, et al. Pulsed
electromagnetic field treatments enhance the healing of fibular osteotomies. J Orthop Res. 2005;23:1035-46 7. Orthofix patient registry. PMA P850007/S20. Data on file.
1.800.535.4492 * www.bonestimulation.com * www.orthofix.com
http://www.bonestimulation.com
http://www.bonestimulation.com
http://www.orthofix.com
http://www.bonestimulation.com
http://www.orthofix.com
Table of Contents for the Digital Edition of APMA News - January 2015
APMA News
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