Aspect Medical Systems’ Letter to the Editor Regarding Anesthesia Awareness Study Published in New England Journal of Medicine
2008-07-24 06:42:00
Aspect Medical Systems’ Letter to the Editor Regarding Anesthesia Awareness Study Published in New England Journal of Medicine
Additional information posted at www.aspectmedical.com
NORWOOD, Mass.–(EMWNews)–Aspect Medical Systems (NASDAQ: ASPM), the global market leader in brain
monitoring technology, today announced that the Company’s
letter to the editor regarding a study and editorial evaluating use of
BIS® technology to reduce the risk of
anesthesia awareness was published in the July 24th issue of the New
England Journal of Medicine (NEJM). The NEJM also
published letters from Dr. Paul Myles and co-investigators from the
Australian B-Aware trial published in The Lancet in 2004, Dr.
Lulong Bo and colleagues from Changhai Hospital in China, Dr. Diamanto
Aretha and colleagues from University Hospital of Patras in Greece, and
Dr. Tim M. Cook, from Royal United Hospital in Bath, United Kingdom.
Responses from Dr. Michael Avidan and colleagues, authors of the NEJM
study, and Dr. Beverly A. Orser, author of the NEJM editorial,
were also published. A link to view this correspondence is available at www.aspectmedical.com.
“The awareness study recently published in the New
England Journal of Medicine has prompted significant discussion
throughout the global anesthesia community concerning the role of brain
monitoring and the issues associated with too little as well as too much
anesthesia,” said Scott Kelley, M.D.,
anesthesiologist and vice president and medical director of Aspect
Medical Systems. “We are pleased that many
leading anesthesia researchers and thought leaders have expressed the
need to consider a variety of outcomes, including avoiding awareness, in
managing a patient’s anesthesia care.”
A recent editorial published in the British Journal of Anaesthesia
(BJA) following the 7th International
Symposium on Memory and Awareness, provided a current assessment of
clinical strategies to avoid awareness, including the role of depth of
anesthesia monitoring. Notably, in commenting upon the NEJM
study, the BJA editorial emphasized that the end-tidal anesthetic
gas protocol used in the NEJM study is not reflective of current
standard practice, but in fact is an alternate practice change that
might be considered by clinicians. A link to this editorial is available
“The BJA editorial also highlights the
emerging concerns related to anesthesia exposure and states that the NEJM
study results support the need to ‘modify
contemporary practice’ with one of the
approaches shown to reduce risk of awareness,”
said Dr. Kelley. “Avoiding awareness is just
one of many goals that anesthesia professionals seek and, given the
extensive clinical evidence and our experience in monitoring more than
27 million patients worldwide, we believe that use of brain monitoring
to help guide anesthetic titration while maintaining a BIS value of less
than 60 is a very effective way to individualize care, minimize
awareness and improve patient outcomes.”
More information related to the NEJM publication can be found at
Aspect’s Web site at www.aspectmedical.com,
including Aspect’s commentary on the Avidan
study and a comparison of the awareness trials led by Dr. Paul Myles and
Dr. Michael Avidan.
Aspect includes in this press release links to its Web site. Aspect
cautions you that the information on this Web site is not incorporated
by reference into this press release and should not be considered to be
a part of this press release.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market leader in
brain monitoring technology. To date, the Company’s Bispectral Index
(BIS) technology has been used to assess approximately 27 million
patients and has been the subject of approximately 3,000 published
articles and abstracts. BIS technology is installed in approximately 79
percent of hospitals listed in the July 2008 U.S. News and World
Report ranking of America’s Best Hospitals and in approximately 75
percent of all U.S. operating rooms. In the last twelve months BIS
technology was used in approximately 19 percent of all U.S. surgical
procedures requiring general anesthesia or deep sedation. BIS technology
is available in more than 160 countries. Aspect Medical Systems has OEM
agreements with nine leading manufacturers of patient monitoring
systems. For more information, please visit the Aspect Medical Systems
Web site www.aspectmedical.com.
Cautionary Statement Concerning Forward-Looking Information
Certain statements in this press release are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995 and
may involve risks and uncertainties, including statements about the
potential benefits of the Company’s brain
monitoring technologies in helping anesthesia providers deliver
anesthesia and in reducing the incidence of awareness and statements
regarding the use and adoption of BIS monitoring technologies. There are
a number of important factors that could cause actual results to differ
materially from those indicated by these forward-looking statements. For
example, future clinical trials and clinician use could demonstrate
different and/or unfavorable results regarding the potential benefits of
the Company’s brain monitoring product. The
Company may also not be able to achieve widespread market acceptance of
its BIS monitoring technology, or to compete with new products or
alternative techniques that may be developed by others, including
third-party anesthesia monitoring products approved by the FDA. Cases of
awareness with recall during monitoring with the BIS system and
significant product liability claims are among the factors that could
limit market acceptance. The Company also faces competitive and
regulatory risks relating to its ability to successfully develop and
introduce enhancements and new products including the BIS VISTA monitor
and products based upon its neuroscience technology. There are other
factors that could cause the Company’s actual results to vary from its
forward-looking statements, including without limitation those set forth
under the heading “Risk Factors” in the Company’s Quarterly Report on
Form 10-Q for the fiscal quarter ended March 29, 2008 as filed with the
Securities and Exchange Commission.
In addition, the statements in this press release represent the
Company’s expectations and beliefs as of the date of this press release.
The Company anticipates that subsequent events and developments may
cause these expectations and beliefs to change. However, while the
Company may elect to update these forward-looking statements at some
point in the future, it specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing the Company’s expectations or beliefs 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.
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