FDA OKs shock wave device for foot ulcers

The FDA on Dec. 28 permitted the marketing of Sanuwave's Dermapace System to treat adults with diabetic foot ulcers.

Here are three things to know.

1. The Dermapace System is an external shock wave device that uses pulses of energy to stimulate wound healing.

2. The device is intended to treat chronic, full-thickness diabetic foot ulcers no larger than 16 centimeters.

3. Recent clinical trials found diabetic patients treated with the Dermapace System exhibited an increase in wound healing 24 weeks after treatment and had a 44 percent wound closure rate, compared to just 30 percent for the control group.

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