FDA Approves dermaPACE® Shock Wave Device for Diabetic Foot Ulcers
On December 28, 2017, the U.S. Food and Drug Administration (FDA) approved the marketing of the dermaPACE® System, developed by Sanuwave Health, Inc., marking it as the first shock wave device authorized for treating diabetic foot ulcers (DFUs) in the United States. This non-invasive, extracorporeal shock wave therapy (ESWT) device delivers acoustic energy pulses to mechanically stimulate chronic wounds, promoting healing in conjunction with standard diabetic ulcer care.
Key Details:
- Indication: Treatment of chronic, full-thickness diabetic foot ulcers extending through the epidermis, dermis, tendon, or capsule, without bone exposure, and with wound areas ≤16 cm².
- Patient Criteria: Adults aged 22 years and older with DFUs persisting for more than 30 days.
- Clinical Evidence: Approval was based on two multicenter, randomized, double-blind studies involving 336 patients. Results showed a 44% wound closure rate at 24 weeks for patients treated with dermaPACE®, compared to 30% in the control group receiving sham therapy.
- Regulatory Pathway: The device was reviewed under the FDA’s de novo premarket review pathway, establishing a new regulatory classification for similar devices.
Read the full article on the Wound Care Advisor website.
Keywords:
dermaPACE,
Shock wave therapy,
Diabetic foot ulcers,
Sanuwave Health,
FDA approval