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FDA permits marketing of device to treat diabetic foot ulcers

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eMediNexus    29 December 2017

The US Food and Drug Administration (FDA) has permitted the marketing of the Dermapace System, the first shock wave device intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.

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