FDA permits marketing of device to treat diabetic foot ulcers
FDA announced on December 28 that it will permit the marketing of the first shock wave device intended to treat diabetic foot ulcers.
FDA announced on December 28 that it will permit the marketing of the first shock wave device intended to treat diabetic foot ulcers. The Dermapace System (Sanuwave, Inc.) is intended to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 that extend through the epidermis, dermis, tendon, or capsule but without bone exposure. The external shock wave system uses pulses of energy to mechanically stimulate the wound. The system is intended for adults, aged 22 years and older, presenting with diabetic foot ulcers lasting for more than 30 days, and it should be used in conjunction with standard diabetic ulcer care. According to CDC, an estimated 30.3 million people in the United States have been diagnosed with diabetes. Approximately one-quarter of those individuals will experience a foot ulcer in their lifetime.