The FDA has permitted the marketing for the first shock-wave device for the use of treating diabetic foot ulcers, according to an agency press release.
The device, Dermapace System from Sanuwave Inc., is intended for treatment of chronic, full-thickness diabetic foot ulcers with wound areas no larger than 16 cm2 extending through the epidermis, dermis, tendon or capsule, without bone exposure. The device is an external system that employs pulses of energy to stimulate the wound and is intended for use in adults aged at least 22 years with diabetic foot ulcers of more than 30 days’ duration. The device should be used along with standard care.
Permission for marketing comes after review of two multicenter, randomized, double-blind studies with 336 patients with diabetes assigned to usual care (wet to dry dressings or removal of the damaged tissues) plus the Dermapace System or usual care and non-working shock-wave therapy. A 44% wound closure rate was observed in the group assigned to the Dermapace System compared with 30% wound closure in the non-working shock-wave therapy group.
“Diabetes is the leading cause of lower limb amputations,” Binita Ashar, MD, director of the division of surgical devices in the FDA’s center for devices and radiological health, said 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.”