Resource Listings Archive

This site provides INTERCEPT product information for Health Care Professionals in the United States.

Improved Operational Efficiencies With Pathogen Reduced Cryoprecipitated Fibrinogen Complex vs. CryoAHF – UTSW Medical Center

by jamesrolloutsf | Jan 23, 2024 | Case Studies, Poster, Product Information

Implementation of Pathogen Reduced Cryoprecipitated Fibrinogen Complex in a Pediatric Level II Trauma Center – Valley Children’s Healthcare

by jamesrolloutsf | Jan 23, 2024 | Case Studies, Poster, Product Information

Implementation & Quality Analysis of Pathogen Reduced Cryoprecipitated Fibrinogen Complex – Stanford University

by jamesrolloutsf | Jan 23, 2024 | Case Studies, Poster, Product Information

Interview: Dr. Maria De Los Angeles Muñiz

by jamesrolloutsf | Jan 19, 2024 | Brochure, Product Information

INTERCEPT Platelets Publications

by jamesrolloutsf | Nov 20, 2023 | Brochure, Product Information

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INTERCEPT® Blood System for Platelets Pathogen Reduction System

INTENDED USE

The INTERCEPT Blood System for Platelets is intended to be used for ex vivo preparation of pathogen-reduced Amicus apheresis platelet components suspended in 65% PAS-3/35% plasma, and Trima apheresis platelet components suspended in 100% plasma in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).

CONTRAINDICATIONS

Contraindicated for preparation of platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens.

Contraindicated for preparation of platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only INTERCEPT Processing Sets for platelets are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet components not exposed to the complete INT100 illumination process.

Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

INTERCEPT® Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex

INTENDED USE

Pathogen Reduced Cryoprecipitated Fibrinogen Complex is indicated for:

Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available.
Second-line therapy for von Willebrand disease (vWD).
Control of uremic bleeding after other treatment modalities have failed.

Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII.

CONTRAINDICATIONS

Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens.

Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex.

For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered.