INTERCEPT BLOOD SYSTEM FOR PLATELETS
PHOTOCHEMICAL TREATMENT (PCT) OF PLATELETS
USING AMOTOSALEN HYDROCHLORIDE AND UVA LIGHT

INTERCEPT Blood System for Platelets

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 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 components. This process is intended to reduce the risk of transfusion-associated transmission of viruses, bacteria, and parasites, prevent transfusion-associated graft versus host disease, and may also reduce
the risk of other 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 platelet components.

INTERCEPT Platelet Processing Sets

The INTERCEPT Blood System for platelets is a sterile, non-pyrogenic fluid path integrated disposable plastic processing set. The INTERCEPT Platelet Processing Sets consist of small volume (SV), large volume (LV) and dual storage containers (DS) disposables. The INTERCEPT processing sets for large volume platelet concentrates and small volume platelet concentrates are each provided as four integral containers in a sealed over-wrap. The INTERCEPT platelet processing set with dual storage containers is provided as five integral containers in a sealed over-wrap. Platelets suspended in plasma with or without additive solution (InterSol Solution) can be processed with this system. Platelets suspended in 100% plasma must be processed using only the LV processing set. When using InterSol, either the LV, DS or SV processing sets can be used and the plasma to InterSol ratio in the suspension medium needs to be approximately 35%/65%. Platelets flow through the amotosalen container into the illumination container. The nominal concentration of amotosalen in the platelet mixture prior to illumination is 150 μM. Photoactivation is provided by the INTERCEPT Illuminator. This ancillary Class I device is microprocessor controlled and delivers a target UVA treatment of 3 J/cm2. Residual amotosalen and free photoproducts are reduced to low levels by exposure to 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 in vivo 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 suspended in 35% plasma and 65% InterSol 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 24ºC with continuous gentle agitation according to applicable blood banking procedures. Any extension of platelet storage time should be evaluated and validated according to local blood bank procedures.

Platelets suspended in 100% plasma that have been processed using the INTERCEPT Blood System may be stored for up to 5 days from time of collection at 20°C to 24ºC with continuous gentle agitation according to applicable blood banking procedures.

Treatment of platelet components with the INTERCEPT Blood System does not cause substantial differences in 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 compared to untreated platelet components.

Technical Data Sheets section page 1 of 7