NEWTON, Mass.--(BUSINESS WIRE)--May 28, 2004--Aspect Medical
Systems (NASDAQ: ASPM) today announced that results from a prospective
study of the potential of BIS(TM) monitoring to reduce the risk of
intraoperative awareness were published in the May 29th issue (volume
363, number 9423) of The Lancet. The study, known as B-Aware,
documented that use of BIS monitoring to help guide anesthetic dosing
reduced the risk of awareness with recall in high-risk patients by 82
percent. The B-Aware study is one of the largest anesthesia-related
investigations ever conducted and the largest to document the value of
BIS monitoring in reducing the risk of patients inadvertently waking
during surgery.
The B-Aware trial was a prospective, randomized, double-blind,
multi-center investigation conducted in 24 hospitals in Australia, New
Zealand, Hong Kong, Thailand and the UK. The study examined 2,500
patients considered to have a high risk of awareness during surgery,
either because they had experienced it before or because they were
undergoing procedures such as heart surgery where a light anesthetic
is preferable.
Findings from B-Aware support results documented in a recent
prospective Scandinavian study, known as Safe 2, published in Acta
Anaesthesiologica Scandinavica in January 2004. The Safe 2 trial was a
prospective historical control trial that examined the general patient
population and found a 77 percent reduction in the incidence of
awareness with recall when BIS monitoring was used. Safe 2 trial
investigators also provided a commentary on awareness research in this
issue of The Lancet.
"Publication of the B-Aware study in the prestigious journal The
Lancet provides additional scientific evidence to the anesthesia
community that BIS monitoring can help reduce the risk of
intraoperative awareness with recall in surgical patients," said Paul
Manberg, PhD, vice president of clinical, regulatory and quality
assurance for Aspect. "This study joins a significant body of clinical
evidence documenting the overall benefits of incorporating BIS
monitoring into current clinical practice. Studies demonstrate that
the device helps anesthesia providers ensure that each patient
receives just the right amount of anesthetic, thereby reducing the
chances of inadvertent overdosing and underdosing."
About BIS Monitoring
Using a sensor placed on the patient's forehead, BIS monitoring
translates information from the electroencephalogram (EEG) into a
single number that represents each patient's level of consciousness.
This number - the BIS value - ranges from 100 (indicating an awake
patient) to zero (indicating the absence of brain activity). Using the
BIS value to guide administration of anesthetic medication, in
conjunction with other vital signs, allows clinicians to make better
informed decisions to achieve optimal anesthesia.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market
leader in brain monitoring technology. Aspect's BIS technology
directly measures the effects of anesthetics and sedatives on the
brain. The technology has been used to assess more than 8.7 million
patients and has been the subject of approximately 1,400 published
articles and abstracts. BIS technology is installed in approximately
32 percent of all domestic operating rooms and is available in more
than 160 countries. Aspect Medical Systems has OEM agreements with
seven leading manufacturers of patient monitoring systems. For more
information, visit Aspect's web site at http://www.aspectmedical.com.
Safe Harbor Statement
Certain statements in this press release are forward-looking and
may involve risks and uncertainties. There are factors that could
cause Aspect's actual results to vary from its forward-looking
statements, including without limitation those set forth under the
heading "Factors Affecting Future Operating Results" in Aspect's
Quarterly Report on Form 10-Q for the fiscal quarter ended April 3,
2004, as filed with the Securities and Exchange Commission. In
addition, any forward-looking statements represent Aspect's views only
as of the date of this press release and should not be relied upon as
representing Aspect's views as of any subsequent date. While Aspect
may elect to update forward-looking statements in the future, it
specifically disclaims any obligation to do so, even if its
expectations change. Therefore, you should not rely on these
forward-looking statements as representing Aspect's views as of any
date subsequent to the date of this press release.
Aspect, Bispectral Index and BIS are registered trademarks of
Aspect Medical Systems, Inc. All other trademarks, service marks and
company names are the property of their respective owners.
CONTACT: Aspect Medical Systems
Emily Anderson, 617-559-7032
eanderson@aspectms.com
SOURCE: Aspect Medical Systems
|