FDA Approves First Shock-Wave Device for Foot Ulcers

The U.S. Food and Drug Administration (FDA) recently approved the marketing of the dermaPACE system, the first shock-wave device for foot ulcers. Its development was based on the previous use of shockwave technology to shatter kidney stones, which led to the development of Pulsed Acoustic Cellular Expression, or PACE.

The dermaPACE device is the first to employ PACE technology for wound treatment.  Using energy pulses to stimulate wounds, it is intended for diabetes patients aged 22 and older who have chronic (more than 30 days), full-thickness diabetic foot ulcers that are no larger than 16 sq. cm. and that extend through the epidermis, dermis, tendon or capsule but do not involve bone exposure.

The FDA approved the device after reviewing the results of two multicenter randomized, double-blind studies. Forty-four percent of those studied experienced wound closure while receiving the PACE treatment.

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