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Clinical Data

What makes EXOGEN different from other bone stimulators?

Did you know?

  • Smokers are 32% less likely to achieve healing than non smokers.6  Click here for more.

Helpful Links

  • Find a Sales Representative
  • Guide to Casting
  • Using and applying EXOGEN◊
  • Reimbursement Support
  • Are you a Patient?
  • Download the EXOGEN◊ Privacy Practices

    (PDF - 76.87 KB)


What makes EXOGEN◊ different from other bone stimulators?

Only EXOGEN◊ Ultrasound uses low-intensity pulsed ultrasound (LIPUS) technology to heal broken bones in only 20 minutes a day.  It is supported by numerous clinical studies.  It is the first and only device ever approved by the FDA to accelerate the healing of indicated fresh fractures1 and non-unions. 2

EXOGEN◊ accelerates healing of indicated fresh fractures by 38%$%1%$ in both cortical and cancellous bone.

Cortical Bone vs. Cancellous Bone

Its never too early or too late to initiate EXOGEN◊ treatment. It accelerates fracture healing at every stage$%4%$

EXOGEN Accelerates Fracture Healing

High heal rates for non-union fractures–86%$%2%$

Heal Rates for Non-Union Fractures

 

 

 

 

EXOGEN◊ heal rates for common fractures5


  • References

1 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;76:26-34.


2 Premarket Approval P900009/Supplement 6. Smith& Nephew.


3 Kristiansen TK, Ryaby JP, McCable J, Frey JJ, Roe LR.  Accelerated healing of distal radius fractures with the use of specific, low-intensity ultrasound.  J Bone Joint Surg Am. 1997;79:961-973


4 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. 2001;16:671-680.


5 Data on file: Post-market patient registry for the period of October 17, 1994 to June 15, 1998


6 Castillo, R et al. Impact of Smoking on Fracture Healing and Risk of Complications in Limb-Threatening Open Tibia Fractures. J. Orthopaedic Trauma March. 2005;19:151- 157.


  • 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.

Contraindications: There are no known contraindications for the EXOGEN◊ device.  Warnings and precautions pertaining to the treatment of either condition may be found at www.exogen.com or by calling 1-800-836-4080.

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

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