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The dermaPACE   System

For patients who suffer from acute and chronic wounds, a novel device has been developed – the dermaPACE System. The mechanism of action is based on shockwave technology which has been used for nearly 30 years in orthopedic treatments and lithotripsy procedures (destruction of kidney stones). These early devices also provided evidence that there was an effect on wound healing. Pulsed Acoustic Cellular Expression (PACE ) Technology was developed based on this evidence, and the dermaPACE System is the first to utilize PACE  specific proprietary protocols for wound treatment.

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What to Expect During treatment with the dermaPACE   System

 

The treatment takes place at your physician’s office or healthcare facility at a scheduled time. You should wear loose-fitting clothing or you may be asked to change into a hospital gown. On the treatment day you should be in overall good health. Before treatment you will be informed of the procedure and asked to sign an informed consent form.

The procedure will begin with the removal of dressings or bandages from the wound. The edges of the wound may be measured to determine the size of the wound. The wound will be gently cleansed, and sterile gel will be applied to the wound. The dermaPACE   Applicator will be gently applied to the wound surface, and treatment will begin. The device makes an audible “popping” sound that will last until the treatment ends. In general only a few treatments lasting a few minutes are needed; however, the treatment time – as well as the number of treatments – depend on the wound condition. After treatment, you will receive standard wound care including a dressing and other instructions from your medical professional. You will receive post-operative instructions from your physician following your procedure, which means you should be an active participant in wound care.

What are the possible side effects or complications?

 

A procedure with the dermaPACE   System has minimal risks. In some cases it can cause reddening, bruising, tingling or numbness. Directly after treatment there may be a brief increase of pain.

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More information?

 

For questions and concerns about a procedure with the dermaPACE  System, please talk to your physician. The physicians using the dermaPACE   System have extensive knowledge and specialized training on all aspects of its use, safety and effectiveness. This website does not replace a conversation with your physician.

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Is it Safe?

 

Yes. Shockwave treatment was originally developed for the treatment of kidney stones over 30 years ago. A wealth of medical experience, state-of-the-art engineering and optimal quality have been built into the dermaPACE   System, and extensive clinical studies and tests have confirmed its safety and efficacy.

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What if I have a Special Health Condition?

 

The safety and effectiveness of PACE   procedures has not yet been determined in people with the following health conditions. Your doctor will provide you with information about how these and other health conditions might affect the outcome of a PACE   procedure.

  • Malignancies in the treatment area

  • Treatments in the head area

  • Treatments on the spinal column

  • Treatments in the lung area

  • Treatments in the area of the gonads

  • Coagulation disorders

 

Little or no experience has been gathered in cases of:

  • Children

  • Pregnant patients

  • Patients with pacemakers

  • Patients with implants in the treatment area

U.S. Indications and Use

 

SANUWAVE's leading product, the dermaPACE  System, is FDA cleared for the treatment of diabetic foot ulcers (DFU). The dermaPACE   System is the first and only device based on shockwave principles cleared by the FDA for such indications.  

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Global Indications and use

 

For international markets, the dermaPACE  System is CE Marked in Europe for advanced wound care indications. The dermaPACE   System and wound indications are currently licensed or approved in dozens of countries and regions around the world. 

The dermaPACE   System is CE Marked for the application of pulsed acoustic waves on acute and chronic defects of the skin and subcutaneous soft tissues, e.g.

  • Post-operative wound healing defects

  • Post-traumatic wounds

  • Deep-partial thickness burns

  • Decubitus ulcers

  • Diabetic ulcers

  • Arterial ulcers

  • Venous ulcer

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For general inquiries, please email info@sanuwave.com

 For device and supply ordering, refurbishments, technical support and customer service, please email order@sanuwave.com,

or call 770-419-7525

Diabetic Foot Ulcer Treatment.  Shockwave Therapy.

3360 Martin Farm Road, Suite 100 Suwanee GA United States 30024

(770) 419-7525

(770) 419-8634 (fax)

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