INTERCEPT Blood System for Platelets
Product Description

The INTERCEPT Blood System for platelets is a Class III medical device that is intended for the ex vivo preparation and storage of whole blood-derived buffy coat platelets and apheresis platelets. The system is used to inactivate a broad spectrum of viruses, bacteria, and parasites as well as contaminating donor leukocytes in platelet products. This process for treatment of platelet 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 platelets.

The INTERCEPT Blood System for platelets is a sterile, non-pyrogenic fluid path integrated disposable plastic processing set. Platelets in 65% InterSol™ Solution (platelet additive solution)/35% plasma flow through the amotosalen container into the illumination container. The nominal concentration of amotosalen in the platelet mixture prior to illumination is 150 mM. 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 J/cm2. Residual amotosalen and photoproducts are reduced to low levels by incubation with a Compound Adsorption Device (CAD), before transfer of the treated platelets to a storage container for release.

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 acid. 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.

InterSol Solution
InterSol Solution (provided separately) is an isotonic buffered salt solution developed specifically for processing and storage of platelets treated with the INTERCEPT Blood System.

INTERCEPT Platelets
Platelets that have been processed using the INTERCEPT Blood System may be stored for up to 7 days from time of collection at 20°C to 24°C with continuous gentle agitation according to applicable blood banking procedures. INTERCEPT Platelets stored up to 7 days have been shown to adequately prevent and control bleeding. Any extension of platelet storage time should be evaluated and validated according to local blood bank procedures.

Treatment of platelet products with the INTERCEPT Blood System does not cause significant differences compared to untreated platelet products in platelet product pH, lactate concentration, platelet count, morphology score, glucose concentration, aggregation, secretory and total adenosine triphosphate concentration, extent of shape change, or platelet hypotonic shock response. 

Technical Data Sheets section page 1 of 7