FDA permits marketing of device to treat diabetic foot ulcers
FDA permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure.
The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care. More information
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Helene Clayton-Jeter
Office of Health and Constituent Affairs
Food and Drug Administration
Visit the FDA Patient Network for more Information about the FDA Diabetes Liaison Program
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