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Medical Devices / Submissions and Approvals

Sanuwave’s Diabetic Foot Ulcer Device Gets FDA Marketing Clearance

Jan. 2, 2018

The FDA has signed off on marketing authorization for Sanuwave’s Dermapace system, a shockwave device used to treat diabetic foot ulcers.

The system uses energy pulses to mechanically stimulate wounds in adult patients whose ulcers last longer than 30 days.

The agency based the clearance on clinical data from two multi-center studies with a total of 336 patients. The studies found patients receiving between one and seven treatments with the device saw improved wound healing at 24 weeks with a 44 percent wound closure rate.

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