FDA Grants Marketing of First Shock Wave Device for Diabetic Foot Ulcers
Patients who received treatment with the Dermapace System had an increase in wound healing at 24 weeks.
The Food and Drug Administration (FDA) has granted marketing clearance of the Dermapace System (Saunwave, Inc.), the first shock wave device intended to treat diabetic foot ulcers.
The Dermapace System is intended for use in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas up to 16cm2 in patients aged ≥22 years, presenting with diabetic foot ulcers lasting over 30 days. The extracorporeal shock wave system uses energy pulses to stimulate the wound and should be used with standard diabetic ulcer care.
The approval was supported by data from 2 multicenter, randomized, double-blind studies involving 336 patients receiving either usual care (wet-to-dry dressings or debridement) as needed plus the Dermapace System therapy or usual care with a sham shock wave therapy.
Data showed patients who received 1 to 7 treatments with the Dermapace System had an increase in wound healing at 24 weeks with a 44% wound closure rate, as compared with a 30% wound closure rate among patients who received the sham shock wave therapy.
Pain during device application, local bruising and numbness, migraines, nausea, fainting, wound infection, cellulitis, osteomyelitis, and fever were among the most commonly seen side effects.
FDA permits marketing of device to treat diabetic foot ulcers. Silver Spring, Maryland: US Food and Drug Administration.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590784.htm. Published December 28, 2017. Accessed January 2, 2018.