FDA approves first shock wave device made to heal wounds

FDA approves first shock wave device made to heal wounds

The Dermapace System claims it can speed healing of diabetic foot ulcers.

Using “acoustic shock waves” to promote healing isn’t just for Overwatch, as Sanuwave has obtained FDA approval for its Dermapace System (Pulsed Acoustic Cellular Expression = PACE). Its approval is specifically to help heal foot ulcers in diabetic patients, where damage to blood vessels and nerves can lead to reduced circulation, infection and sometimes amputation. The Dermapace mechanically stimulates the wound, which Sanuwave says promotes healing. Like several other “first” FDA approvals we’ve seen recently, this device went through the de novo review process designed specifically to get new technology on the market.

After two double-blind studies, the results showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate with the real Dermapace device, vs. a 30 percent closure rate for patients treated with a fake system. Now that this device has been approved, it also opens the door for similar technology, if it can show that it’s “substantially equivalent.”

One comment

  • uhm

    You can tackle all ulcers without such a device by letting the body repair itself after being given its needs. These needs would include packing the wound with Manuka honey mixed with sugar daily and if any infection starts (which should smell) then utilize colloidal silver (I used the silver) or Potassium Iodide (do not use potassium iodide if the patient is taking the thyroxine drug for a hypo-thyroid or if they have a hyper-thyroid condition [this can only be done with the energy signature at a particular potency and never with the physical compound] over the area and continue with the sugar. To help prevent or tackle an infection you can use the extracted energy signature of gunpowder. Three times per day the ulcer sufferer should consume Calc Sulf and Kali Dichrom as well as the other twelve tissue salts Some other remedies like Calc Carb may be needed and also the use of a constitutional remedy to help the healing along. An intake of mid-stream fresh urine should be ingested twice daily. I’ve recently removed a leg ulcer the width of one inch and around four to five millimetres in depth over a period of months from someone in her sixties suffering edema from a chronic deep-vein thrombosis. As you can see if you have some patience and you give the body its needs then even as one gets older you’ll still see results that others can only wish for.

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