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Other Cellular and/or Tissue Based Products (CTPs)

Other Cellular and/or Tissue Based Products (CTPs)

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Other Cellular and/or Tissue Based Products (CTPs)

Other Cellular and/or Tissue Based Products (CTPs) are not Acellular matrix, Allogeneic matrix, Composite matrix, or  Human Skin Allografts but have U.S. Food and Drug Administration (FDA) clearance/approval or are designated 361 HCT/P exemption, and are used in accordance with that product’s individualized application guidelines (e.g., autologous blood clot).

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Topic 1580 Version 1.0

SUBTOPICS

ActiGraft® is an FDA-cleared regenerative wound care solution that enables health care providers   to produce—in real time—in vitro blood clots from a patient’s whole blood. Once applied, the blood  clot tissue serves as a protective covering, biologic scaffold and wound microenvironment to  promote the natural wound healing processes of the body.ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg  ulcers, p

RELATED TOPICS

Human Skin Allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection.

Allogeneic Matrices are cellular and/or tissue products usually derived from human neonatal fibroblasts of the foreskin, and may contain metabolically active or regenerative components

Composite Matrices are a type of cellular and/or tissue products derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen.

Skin Substitute:Duration of ulcer - approximately 89 weeksWound free of infection, osteomyelitis, surrounding cellulitis, tunnels/tracts, necrotic tissue - yesInitial Application/Reapplication - 3rd applicationSkin substitute used - Grafix PrimeMethod of fixation - Mepitel, steristripsLot # - A160300Unit # - 16003Part # - PS60013Expiration date - 6/14/18