INTERCEPT Blood System for Plasma
Photochemical Treatment (PCT) of Plasma Using
Amotosalen Hydrochloride and UVA Light
The INTERCEPT Blood System for plasma is a Class III medical device that is intended for the ex vivo preparation and storage of pathogen inactivated plasma intended for transfusion. The INTERCEPT Blood System for plasma is used to inactivate bacteria, viruses, parasites, and leukocytes. This process for treatment of plasma products is intended to reduce the risk of transfusion-associated transmission of viruses, bacteria, and parasites, and may also reduce the risk of adverse effects due to transfusion of contaminating donor leukocytes. The device uses amotosalen HCl (a photoactive compound) and long-wavelength ultraviolet (UVA) illumination to photochemically treat plasma.
The INTERCEPT Blood System for plasma is a sterile, non-pyrogenic fluid path integrated disposable plastic processing set. The set consists of 15 mL of amotosalen solution in a plastic container, a plastic illumination container, a compound adsorption device, and three plastic storage containers, all sequentially integrated. The single-use set is manufactured from inert polyolefin PL 2411, PL 2410, and PL 269 plastics compatible with plasma.
Plasma collected by apheresis or prepared from whole blood (containing <4x106 RBC/mL) is connected to the processing set using a sterile-connect device. Plasma to be treated is in a volume range of 385 mL to 650 mL, including anticoagulant and prior to addition of amotosalen. Plasma flows through the amotosalen container and into the illumination container. Prior to illumination the nominal concentration of amotosalen in plasma is 150 μM. Illumination is provided by the INTERCEPT Illuminator. This ancillary Class I device is microprocessor controlled and is designed to deliver a target UVA treatment of 3 Joules/cm2.
The INTERCEPT Plasma processing set includes a compound adsorption device (CAD), which significantly reduces the level of residual amotosalen in plasma prior to storage. The CAD consists of ground adsorbent beads and an ultra-high molecular weight polyethelene binder. The illuminated plasma flows by gravity through the CAD and into the storage containers. INTERCEPT Plasma is stored according to requirements for frozen plasma until released for transfusion.
Amotosalen Hydrochloride
Amotosalen HCl is a synthetic psoralen compound that reversibly intercalates into the helical regions of DNA and RNA. Upon illumination with UVA light at 320 to 400 nm, amotosalen forms covalent bonds with pyrimidine bases in nucleic acids. The genomes of pathogens and leukocytes cross-linked in this manner can no longer function or replicate. No pharmacological effect of residual amotosalen is intended.
INTERCEPT Plasma
Indications
INTERCEPT Plasma is indicated for support of patients requiring plasma transfusions or therapeutic plasma exchange, according to clinical practice guidelines. Clinical trials in patients have demonstrated that plasma treated with the INTERCEPT Blood System was well tolerated and retained therapeutic efficacy comparable to conventional fresh frozen plasma. INTERCEPT Plasma may be used to treat single coagulation factor or antithrombotic protein deficiencies for which no concentrates are available, as well as multiple coagulation factor and antithrombotic protein deficiencies. INTERCEPT Plasma may also be used for plasma exchange for thrombotic thrombocytopenic purpura (TTP). INTERCEPT treatment may be used as an alternative to gamma irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD). Plasma photochemically treated with the INTERCEPT Blood System may be stored and transfused according to standard methods for frozen plasma. Pathogen Inactivation Claims In non-clinical studies, the INTERCEPT Blood System for plasma demonstrated inactivation of viruses, bacteria, parasites, and donor leukocytes.
Pathogen Inactivation Claims
In non-clinical studies, the INTERCEPT Blood System for plasma demonstrated inactivation of viruses, bacteria, parasites, and donor leukocytes.
Plasma Technical Data Sheet Page 1 of 7
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