Munich, Germany (ots/PRNewswire)
- Longer Storage Period Makes Platelets More Readily Available to
European Transfusion Blood Centers
European subsidiaries of Baxter International Inc. (NYSE: BAX) and
Cerus Corporation (NASDAQ: CERS) today announced that they have
received CE Mark Certification from TÜV Product Service GmbH
extending the storage period for platelets treated with their
INTERCEPT Platelet System from five to seven days. TÜV is an
internationally recognized compliance organisation.
"This is a major achievement for the INTERCEPT Blood System that
represents an important step forward for transfusion blood centers
all over Europe. Due to the extension of platelet shelf life,
transfusion centers will now be able to store platelets up to seven
days and have them more readily available for transfusion," said
Jocelyne Flament, Medical Director Baxter.
In addition, the INTERCEPT Blood System provides enhanced patient
safety by reducing the risk of transfusion-transmitted diseases
through blood transfusions.
Longer and quicker availability of platelets
The extended shelf life up to seven days allows transfusion
centers in Europe to store platelets longer, enabling them to reduce
products discards and improve inventory management, as platelets are
available to transfusion patients for up to two more days.
Furthermore, the INTERCEPT Blood System also allows for earlier
availability of platelet products. Indeed, the method used by
bacterial testing systems needs up to 24 hours for sampling and 24 to
36 hours for detection process, which means results are generally
only available 2 days after collection at the earliest. This reduces
the actual availability of the platelets to two to three days.
Platelets that have been treated with the INTERCEPT Blood System are
available immediately after the inactivation process. Therefore, with
the 7-day approval, the actual shelf-life of Intercept Platelets will
be 6 to 7 days depending upon when the process occurs.
With the INTERCEPT Blood System, no additional sampling steps are
required. Bacterial detection systems can have limitations, including
possible sampling errors, long incubation times before certain
pathogens can be identified and are limited to bacterial detection.
In addition, tests have indicated the possibility of false-negative
results that can lead to fatal bacterial sepsis, and false-positive
results which can cause discards of otherwise acceptable platelet
products and increased cost.
"We are pleased to make the Intercept Blood System for Platelets
even more useful to the blood centers in extending platelet shelf
life and reducing the risk of recalls associated with culture
positive products," says Larry Corash, vice president and chief
medical officer, Cerus.
Enhanced patient safety
The INTERCEPT Blood System is designed to protect patients by
reducing the risk of transfusion-transmitted diseases. It goes beyond
current blood safety measures by effectively inactivating a broad
range of pathogens, including viruses, bacteria, parasites and
leukocytes that can be found in platelets. Due to its specific
inactivation technology, the INTERCEPT Blood System addresses broader
safety risks and may also protect against as yet unknown, emerging
pathogens which may threaten the blood supply in the future.
About the INTERCEPT Blood System
The INTERCEPT Blood System is designed to reduce the risk of
transfusion-transmitted diseases by inactivating certain pathogens
that may be present in donated blood components, such as bacteria,
HIV, and hepatitis B and C viruses. The INTERCEPT Blood System was
the first pathogen inactivation system approved in Europe to treat
platelets for transfusion. The INTERCEPT Blood System is also being
developed for the treatment of plasma and red blood cells.
Baxter, through its subsidiaries, assists healthcare professionals
and their patients with the treatment of complex medical conditions,
including cancer, hemophilia, immune disorders, kidney disease and
trauma. The company applies its expertise in medical devices,
pharmaceuticals and biotechnology to make a meaningful difference in
Cerus Corporation is developing novel products for cancer,
infectious diseases, and blood safety based on multiple, innovative
technology platforms. The company is building a pipeline of next
generation cancer immunotherapies by combining its proprietary
attenuated Listeria vector platform with promising disease antigens.
These products are designed to stimulate innate and T-cell immune
pathways in order to generate highly potent anti-tumor responses.
Cerus is applying its Helinx technology to develop the INTERCEPT
Blood System, which is designed to enhance the safety of blood
components through pathogen inactivation. The company's strategy is
to leverage the broad potential of its technologies and products
through alliances. Cerus' partners to date include MedImmune and
Johns Hopkins University for cancer immunotherapy, and Baxter
International and BioOne for the INTERCEPT Blood System.
Baxter, INTERCEPT Blood, and INTERCEPT AND PROTECT are trademarks
of Baxter International Inc. Cerus and Helinx are U.S. registered
trademarks of Cerus Corporation.
TÜV (Technischer Überwachungs-Verein) Product Services is one of
the world leading organizations in the field of product testing,
verification, consultancy and certification during the development
and manufacture of products with regard to safety, electromagnetic
compatibility, telecommunication competency, usability and quality.
Around 1000 employees carry out certifications according to all
current international standards. For manufacturers of medical
devices, TÜV offers support with regard to certification and CE
Statements in this news release regarding potential efficacy and
safety of products, potential regulatory approvals, product
development and commercialization are forward-looking statements that
involve risks and uncertainties. Actual results could differ
materially from the above forward-looking statements as a result of
certain factors, including the risks and uncertainties related to the
timing and results of clinical trials and other development
activities, the acceptability of any data by regulatory authorities,
actions by regulatory authorities and other government authorities,
including the FDA and foreign counterparts, at any stage of the
development or marketing process, technological advances in the
medical field, additional financing activities, manufacturing,
product demand and market acceptance and adoption of any products,
competitive conditions, internal and external factors that could
impact commercialization, and other factors discussed in each
company's filings with the Securities and Exchange Commission. The
companies do not undertake any obligation to update any
forward-looking statements as a result of new information, future
events, changed assumptions or otherwise; all forward-looking
statements speak only as of the time when made. Actual results or
experience could differ materially from the forward-looking
 te Boeckhorst PAW, Beckers EAM, Vos MC, Vermeij H, van Rhenen
DJ: Clinical significance of bacteriologic screening in platelet
concentrates. Transfusion 2005;45:514-519.
Claeys H, Logghe F, Vandekerchove B, et al: Four-year experience
with routine bacterial screening of platelet concentrates. Transfus
Med 2003;1(Suppl 1):S326.
ots Originaltext: Baxter Healthcare SA
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