The dermaPACE System, reportedly the first shock wave device intended to treat diabetic foot ulcers, has received marketing approval from the US Food and Drug Administration.
The system, developed by Sanuwave Health Inc, Suwanee, Ga, is intended for use by adult patients (age 22 and older) with chronic, full-thickness diabetic foot ulcers that measure no larger than 16 cm2 (about the size of a soda can top) and extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. It is designed to use pulses of energy, similar to sound waves, to mechanically stimulate wound healing.
The FDA granted its approval after reviewing clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients who received either usual care, which includes wet-to-dry dressings or debridement as needed, plus the dermaPACE System shock wave therapy, or the usual care plus sham shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.
The patients who had between one and seven treatments with the dermaPACE System showed an increase in wound healing at 24 weeks with a 44% wound closure rate. Those patients treated with the sham shock wave therapy showed a 30% wound closure rate during the same time period, explains a media release from the US Food and Drug Administration.
“Diabetes is the leading cause of lower limb amputations,” says Binita Ashar, MD, director of the division of surgical devices in FDA’s Center for Devices and Radiological Health, in the release.
“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”
[Source(s): US Food and Drug Administration, PR Newswire]