FDA clears Repliderm dressing
FDA clears Repliderm dressing
T he U.S. Food and Drug Administration (FDA) has granted clearance to Orphan Medical’s Repliderm Wound Dressing. While this eliminates an important hurdle for the product, the approval does not fully support indications that Orphan Medical in Minneapolis considers important to successfully market Repliderm, according to the company. Orphan Medical says it will not market Repliderm until clinical trials to evaluate all indications are completed.The FDA application addresses the use of Repliderm as a collagen-based dressing for the management of pressure ulcers (stages I-IV), stasis ulcers, first- and second-degree burns, diabetic ulcers, foot ulcers, post-surgical incisions, cuts, abrasions, partial thickness wounds, skin conditions associated with peristomal care, and wound exudate absorption. Orphan Medical’s planned trials will evaluate whether Repliderm accelerates healing of pressure ulcers. t
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