How many blood systems can help you be certain?
ONE. ONE System for Platelets and Plasma
ONE System for Pathogens and Leukocytes
The same illumination device, process and active compound for treating both apheresis and whole blood collections.
Broad-spectrum inactivation of viruses, bacteria and parasites; the only PI system CE marked as an alternative to gamma irradiation for prevention of transfusion-associated graft-vs.-host disease.
INTERCEPT Pathogen Inactivation: Consistent Confidence from Day One While the safety of the worldwide blood supply may be assumed, the limitations of donor screening processes and blood testing methodologies still provide a wide window of opportunity for risk due to known and emerging pathogens.
Doubt is a luxury that no one can afford. How can you have greater confidence in the safety of your blood supply, both today and tomorrow? How can you mitigate the risk without an unacceptable increase in cost and labor?
Consider the INTERCEPT Blood System from Cerus. Using a proprietary nucleic acid crosslinking technology, INTERCEPT proactively addresses risk at the source by inactivating a broad range of known and emerging blood-borne viruses, bacteria and parasites, as well as leukocytes. As reported by clinical investigators, INTERCEPT significantly reduces the rate of transfusion reactions.1,2 And INTERCEPT is well supported by extensive clinical studies and compliance with medical device and drug approval standards.
INTERCEPT provides: > ONE system offering proven inactivation
greater than 5 logs for a broad range of enveloped and non-enveloped viruses, both intracellular and extracellular, as well as bacteria and protozoa; leukocytes are also inactivated > ONE system that can replace gamma irradiation, bacterial detection1,3 and CMV testing1,3 for platelets
> ONE illumination device and the same process for both platelets and plasma > ONE treatment approach that preserves the therapeutic properties of blood components > ONE process that provides high product throughput (20 platelet or 36 plasma units/hour/instrument) > ONE platform compatible with whole blood and apheresis collections
Discover how INTERCEPT can be the one for your facility.
The INTERCEPT Blood System: One System for Two Components Treats Whole Blood and Apheresis Collections INTERCEPT platelet and plasma treatment kits are designed for use with whole blood collections and with a wide variety of platforms for apheresis collection.
CE-Marked as an Alternative to Gamma Irradiation The only pathogen inactivation system designated as an alternative to gamma irradiation for prevention of transfusion-associated graft-vs.-host disease.
Unique Mechanism of Action with Amotosalen HCl and UVA Light > Amotosalen penetrates cellular and nuclear membranes, intercalating into helical regions of DNA and RNA > Covalent crosslinks to nucleic acid base pairs form upon exposure to UVA light > DNA and RNA replication are blocked, inactivating leukocytes and pathogens and rendering them incapable of causing disease > The therapeutic efficacy of platelets and plasma is fully retained
Designed for Convenient and Cost-Effective Implementation INTERCEPT treatment is optimized for convenient and cost-effective integration with conventional platelet and plasma production and storage needs.
P L AT E L E T S
One Treatment Produces Up to 2 Platelet Doses
One Treatment Produces Up to 3 Plasma Transfusion Units
Can be used with double-dose platelet collections (up to 7.0 x 1011 platelets), allowing one treatment to produce up to two platelet doses for transfusion; can be stored for up to 7 days per local regulatory guidelines. Platelet Additive Solution Replaces Donor Plasma During Collection Production of platelets in 65% InterSol platelet additive solution allows recovery of additional plasma with each platelet collection, and reduces each platelet recipient’s exposure to donor plasma.
The INTERCEPT plasma kit is designed to treat jumbo volumes of plasma (385–650 mL), allowing one treatment to yield 2–3 units of INTERCEPT Plasma (200–300 mL each).
Integrated Platelet Set
Step 1 Amotosalen
Step 2 Illumination
Step 3 CAD
INTERCEPT Platelets Storage*
*Small Volume and Large Volume configurations currently available with one storage bag. A dual storage bag configuration is planned for early 2009.
P L AT E L E T A N D P L A S M A T R E AT M E N T P R O C E S S
Collected platelets or plasma are sterilely connected to the INTERCEPT kit
before processing. Amotosalen (step 1) is added by gravity flow and the mixture is illuminated with UVA light (step 2). Residual amotosalen and its photoproducts are reduced to low levels using a compound adsorption device (CAD) (step 3) before transfer to the storage container(s).
Integrated Plasma Set
Step 1 Amotosalen
Step 2 Illumination
Step 3 CAD
INTERCEPT Plasma Storage
The INTERCEPT Blood System for Platelets and Plasma: Proactive, Proven Pathogen Inactivation > P roactively inactivates a broad range of known and emerging blood-borne viruses, bacteria and parasites, as well as leukocytes > Can replace gamma irradiation, bacterial detection1,3 and CMV testing1,3 >O ffers the convenience of inactivation for platelets and plasma using the same illumination device and treatment process > Retains therapeutic properties of platelets and plasma > Over 150,000 treated units transfused in 14 European countries For more information on how INTERCEPT can be the one for your facility, contact your Cerus representative today.
Broad Spectrum of Pathogen Protection Enveloped Viruses • HIV-1/2 • HBV • DHBV • HCV • BVDV • HTLV- I/II • CMV • WNV • SARS-CoV4 • Vaccinia4 • Chikungunya5 • Dengue6 • Avian flu virus (H5N1)7 Non-Enveloped Viruses • Bluetongue virus, type 11 • Simian adenovirus 15 • Feline calcivirus • Parvovirus B19 • Human adenovirus 5
Gram-Negative Bacteria • Klebsiella pneumoniae • Yersinia enterocolitica • Escherichia coli • Pseudomonas aeruginosa • Salmonella choleraesuis • Enterobacter cloacae • Serratia marcescens Gram-Positive Bacteria • Staphylococcus epidermidis • Staphylococcus aureus • Streptococcus pyogenes • Listeria monocytogenes • Corynebacterium minutissimum • Bacillus cereus (vegetative) • Lactobacillus sp. • Bifidobacterium adolescentis • Propionibacterium acnes • Clostridium perfringens
Spirochetes • Treponema pallidum • Borrelia burgdorferi Parasites • Trypanosoma cruzi • Plasmodium falciparum • Leishmania sp. • Babesia microti Leukocytes
The INTERCEPT Blood Systems for platelets and plasma are CE marked and produced to ISO 13485 Quality Standard. France
INTERCEPT Platelet and Plasma product characteristics approved by Afssaps and published in the Journal Officiel. Germany
First blood center marketing authorization approved by PEI for INTERCEPT Platelets in 2007.
Indications for INTERCEPT Platelets — INTERCEPT Platelets are indicated for transfusion support of
patients requiring platelet transfusions according to clinical practice guidelines. Any thrombocytopenia resulting from disease, therapy or injury can be treated with INTERCEPT Platelets. INTERCEPT Platelets are not clinically different from untreated platelets and are infused according to standard platelet infusion methods.
Indications for INTERCEPT Plasma — 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. Plasma photochemically treated with the INTERCEPT Blood System may be stored and transfused according to standard methods for frozen plasma.
Contraindications — Use of INTERCEPT Plasma and Platelets is contraindicated in patients with a history of allergic response to amotosalen or psoralens.
© 2008 Cerus Corporation. Cerus, INTERCEPT Blood System, and Be Sure are trademarks of Cerus Corporation. MAN-EN 00058, v2.0
Note to Physicians — No pathogen inactivation system has been shown to inactivate all pathogens.
1. Osselaer JC, Doyen C, et al. Blood 2005;106(11):129a. 2. Witt V et al. Vox Sang 2006;91(Suppl 3):178. 3. Isola H, Kienz D, et al. Vox Sang 2007;93(Suppl 1):165. 4. Lin L, Hanson CV, Alter HJ, et al. Transfusion 2005;45:580-90. 5. Sawyer L, Sampson-Johannes A, Dubensky T, et al. Vox Sang 2007;93(Suppl 1):170. 6. Lam S, Tan HC, Tan LK, Ng LC, Teo D, Koh M. Transfusion 2007;47(Suppl 3):131A. 7. Dupuis K, Sawyer L. Vox Sang 2008;95(Suppl 1):301.
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e-mail: email@example.com | www.interceptbloodsystem.com | www.cerus.com
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