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Smith
Nephew

 

EXOGENSNTM

Ultrasound Bone Healing System

FAQs

  • Guide to EXOGEN
  • Tips & Tricks
  • Support for patients
  • Reimbursement
  • Clinical Trials
  • Resources

Did you know?

EXOGEN Ultrasound Bone Healing System
  • You can use EXOGEN◊ with an established cast.  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)

References

  • Click here to go to the FAQ References page

EXOGEN Frequently Asked Questions

  1. How deep and wide is the biologic effect of EXOGEN◊ Ultrasound?
  2. Is EXOGEN◊ treatment effective with deep fractures such as in the femur?
  3. Is EXOGEN◊ ultrasound able to penetrate bone?
  4. Is EXOGEN◊ ultrasound able to treat the entire fracture?
  5. Is EXOGEN◊ safe with metal fixation?
  6. Does EXOGEN◊ have any contraindications?
  7. Is EXOGEN◊ safe to use in the presence of a cardiac pace maker or other active, implantable device?
  8. How do I contact an EXOGEN◊ sales representative?
    • 1
      How deep and wide is the biologic effect of EXOGEN◊ Ultrasound?
      • Answer:

        The EXOGEN◊ ultrasound beam expands to reach a width of almost 2.5x transducer.  The EXOGEN◊ ultrasound waves can penetrate through skin and soft tissue to reach bone up to 26.5 cm (10.5 inches) deep.1

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    How deep and wide is the biologic effect of EXOGEN◊ Ultrasound? The EXOGEN◊ ultrasound beam expands to reach a width of almost 2.5x transducer.  The EXOGEN◊ ultrasound waves can penetrate through skin and soft tissue to reach bone up to 26.5 cm (10.5 inches) deep.1 B7778529680D4444835589E2F15DE64C 11544 /html/GUIDE_TO_EXOGEN.htm
    • 2
      Is EXOGEN◊ treatment effective with deep fractures such as in the femur?
      • Answer:

        In clinical trials, EXOGEN◊ treatment had a success rate of 92% in treating non-unions of the femur2 – suggesting EXOGEN◊ therapy is an excellent choice for patients with deep fractures.  In fact, 95% of Americans have a thigh circumference of less than 88.9cm (35 inches), which means the distance between skin and femur is generally less than 14.3cm (5.6 inches).3

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    Is EXOGEN◊ treatment effective with deep fractures such as in the femur? In clinical trials, EXOGEN◊ treatment had a success rate of 92% in treating non-unions of the femur2 – suggesting EXOGEN◊ therapy is an excellent choice for patients with deep fractures.  In fact, 95% of Americans have a thigh circumference of less than 88.9cm (35 inches), which means the distance between skin and femur is generally less than 14.3cm (5.6 inches).3 7FD7FFC915E74708ABC29C660987C0AF 11548 /html/GUIDE_TO_EXOGEN.htm
    • 3
      Is EXOGEN◊ ultrasound able to penetrate bone?
      • Answer:

        Testing shows the EXOGEN◊ ultrasound waves can easily penetrate bone4 – enabling the biological effect to spread around the entire fracture site.

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    Is EXOGEN◊ ultrasound able to penetrate bone? Testing shows the EXOGEN◊ ultrasound waves can easily penetrate bone4 – enabling the biological effect to spread around the entire fracture site. B2833E38350747F2B899700A9660CD2F 11550 /html/GUIDE_TO_EXOGEN.htm
    • 4
      Is EXOGEN◊ ultrasound able to treat the entire fracture?
      • Answer:

        Tibia fractures up to 6.35 cm (2.5 inches) in length were healed in clinical trials using the EXOGEN◊ system.5  The biological effect of the ultrasound beam spreads around the entire fracture by: stimulating cells facing the transducer, penetrating bone to stimulate cells on the bone’s far side, transmitting longitudinal and shear waves around the bone.6  The EXOGEN◊ system is able to treat fractures larger than the actual beam because of cell-to-cell communication.

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    Is EXOGEN◊ ultrasound able to treat the entire fracture? Tibia fractures up to 6.35 cm (2.5 inches) in length were healed in clinical trials using the EXOGEN◊ system.5  The biological effect of the ultrasound beam spreads around the entire fracture by: stimulating cells facing the transducer, penetrating bone to stimulate cells on the bone’s far side, transmitting longitudinal and shear waves around the bone.6  The EXOGEN◊ system is able to treat fractures larger than the actual beam because of cell-to-cell communication. C6C8D48828894087BAE08CE2913C5D64 11549 /html/GUIDE_TO_EXOGEN.htm
    • 5
      Is EXOGEN◊ safe with metal fixation?
      • Answer:

        Yes. The Low Intensity Pulsed Ultrasound technology in EXOGEN◊ is non-cavitating and non-thermal.7,8  Testing shows that it produces no untoward effects or migration of fixation.9

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    Is EXOGEN◊ safe with metal fixation? Yes. The Low Intensity Pulsed Ultrasound technology in EXOGEN◊ is non-cavitating and non-thermal.7,8  Testing shows that it produces no untoward effects or migration of fixation.9 3B128796FC284A428F64CA548769FDEF 11551 /html/GUIDE_TO_EXOGEN.htm
    • 6
      Does EXOGEN◊ have any contraindications?
      • Answer:

        No. There are no known contraindications to the use of the EXOGEN◊ device.10

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    Does EXOGEN◊ have any contraindications? No. There are no known contraindications to the use of the EXOGEN◊ device.10 A0A1755CAE0648639781C88D5CE34559 11546 /html/GUIDE_TO_EXOGEN.htm
    • 7
      Is EXOGEN◊ safe to use in the presence of a cardiac pace maker or other active, implantable device?
      • Answer:

        The operation of active, implantable devices, such as cardiac pacemakers may be adversely affected by close exposure to the EXOGEN◊ device. Physicians should advise patients or other persons in close proximity during treatment to be evaluated by the attending cardiologist or physician before starting treatment with the EXOGEN◊ device.10

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    Is EXOGEN◊ safe to use in the presence of a cardiac pace maker or other active, implantable device? The operation of active, implantable devices, such as cardiac pacemakers may be adversely affected by close exposure to the EXOGEN◊ device. Physicians should advise patients or other persons in close proximity during treatment to be evaluated by the attending cardiologist or physician before starting treatment with the EXOGEN◊ device.10 FFC3C66B313F4E0AA0BC608665ACBE2A 11547 /html/GUIDE_TO_EXOGEN.htm
    • 8
      How do I contact an EXOGEN◊ sales representative?
      • Answer:

        To find a local EXOGEN◊ specialist in your area, please call the customer service line at 800-836-4080, Option 2 or e-mail us at ctreimbursementservices@smith-nephew.com.

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    How do I contact an EXOGEN◊ sales representative? To find a local EXOGEN◊ specialist in your area, please call the customer service line at 800-836-4080, Option 2 or e-mail us at ctreimbursementservices@smith-nephew.com. C43A0D718BBC464F922FB78F6576CE9A 11545 /html/GUIDE_TO_EXOGEN.htm

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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