FDA OKs Marketing of Shock Wave Device for Diabetic Foot Ulcers

The FDA has permitted marketing of a new device intended to treat diabetic foot ulcers, agency officials said in a statement.

The Dermapace System (Sanuwave Inc) is the first shock wave device intended to treat diabetic foot ulcers, according to the statement. It works by using a pulse of energy similar to sound waves to mechanically stimulate the wound.

The Dermapace System is indicated to be used in adult patients for the treatment of chronic, full-thickness diabetic foot ulcers, with wound areas measuring no longer than 16 cm,² which extend through the capsule, epidermis, dermis, or tendon but without bone exposure. The device is intended for patients with diabetic foot ulcers lasting for more than 30 days, and it should be used along with standard diabetic ulcer care.

The FDA’s decision is based on clinical data from 2 trials, including 336 patients with diabetes receiving either usual care (wet-to-dry dressing or debridement), plus the Dermapace System shock wave therapy, or usual care plus non-working shock wave therapy. Patients who received between 1 and 7 treatments with the device showed an increase in wound healing at 24 weeks, with a 44% wound closure rate, compared with patients treated with the placebo therapy who demonstrated a 30% wound closure rate.

The most common adverse effects associated with the device’s use were pain during application, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound, and fever.

The FDA reviewed the product through the de novo premarket review pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

Reference

FDA permits marketing of device to treat diabetic foot ulcers [news release]; December 28, 2017. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590784.htm?utm_campaign=12282017_PR_FDA%20clears%20Dermapace&utm_medium=email&utm_source=Eloqua. Accessed December 28, 2017.