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.

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.

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.

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.

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.

Find Clinics Near You

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.