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Smith & Nephew, Largo, FL, has announced plans to cease manufacturing Dermagraft and related products. The decision came after receiving a nonapprovable letter from the Food and Drug Administration (FDA) in relation to the US marketing of Dermagraft for treatment of venous leg ulcers. The FDA had requested additional clinical studies that the company said would delay approval for 18 to 24 months.


Dermagraft, a cryopreserved human fibroblast-derived dermal substitute, had previously been approved for treatment of full-thickness diabetic foot ulcers of greater than 6 weeks' duration that extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.


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The Centers for Medicare & Medicaid Services has approved the Versatile 1 Wound Vacuum System from BlueSky Medical, Carlsbad, CA, for reimbursement under HCPCS code E2402 for use in negative pressure wound therapy. Associated canisters and Chariker-Jeter kits may be reimbursed under related codes. The change is effective immediately.


BlueSky Medical has also introduced to its wound care line the Aqualert overflow alarm with smaller, 250-mL canisters and the Miller DermiVex drain.


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