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Aspect Medical Systems Provides Commentary and Information on New England Journal of Medicine Study on Anesthesia Awareness and the Bispectral Index.


-Information for patients, medical professionals posted at www.aspectmedical.com-

NORWOOD, Mass. -- Aspect Medical Systems (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ASPM ASPM Abnormal Spindle-Like Microcephaly Associated
ASPM Asociación del Secretariado Profesional de Madrid (Spanish: Association of the Professional Secretaryship of Madrid)
ASPM Armed Services Procurement Regulation Manual
), the global market leader in brain monitoring technology, commented today on the results from a prospective study of the potential of the Bispectral Index A Bispectral index (BIS) monitor is a modern neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia. [TM] (BIS[TM]) to reduce the risk of anesthesia awareness Anesthesia awareness, or "unintended intra-operative awareness" occurs during general anesthesia, when a patient has not had enough general anesthetic or analgesic to prevent consciousness and the recall of events. Background
In about 0.
. The study, published in the March 13 issue of the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  (NEJM NEJM New England Journal of Medicine ), evaluated a patient population considered to be at high risk for anesthesia awareness, or inadvertent waking during surgery. Researchers compared BIS-guided anesthesia care with a protocol based on end-tidal anesthetic gas (ETAG ETAG Ethical Trading Action Group
ETAG European Technical Approval Guideline (European Organisation for Technical Approvals)
ETAG Extended Task-Action Grammar
ETAG European Travel & Tourism Action Group
) guided care and found a similar occurrence of awareness in the two groups. The authors concluded that no benefit of BIS monitoring was demonstrated. The results of the BIS-guided care group in the study were consistent with findings from the BIS-guided care group from the B-Aware study published in The Lancet in May 2004. The low incidence measured in the NEJM study represents an 80 percent reduction from the expected rate of awareness in these patients as documented in numerous studies.

"We are pleased that BIS-guided care in the NEJM study again confirms the ability of BIS monitoring to help clinicians achieve a low incidence of awareness in high-risk patient populations," said Scott Kelley, M.D., anesthesiologist Anesthesiologist
A medical specialist who administers an anesthetic to a patient before he is treated.

Mentioned in: Anesthesia, General, Appendectomy, Parathyroidectomy

anesthesiologist
 and vice president and medical director of Aspect Medical Systems. "Nonetheless, the authors of the NEJM study did not feel that their results support the routine use of BIS monitoring, however, we believe that clinicians need to consider and balance several factors as they interpret the study results."

The most notable difference between the earlier B-Aware study and the NEJM study is the composition of the control groups. While the B-Aware trial investigators compared BIS-guided care with routine standard clinical practice, the authors of the NEJM study compared BIS-guided care with a protocol-based approach to anesthetic administration. In addition, the NEJM study does not include data regarding recovery end-points.

"The ETAG-guided protocol used in the NEJM study instructed the anesthesia professionals to use a certain amount of inhaled anesthetics Anesthetics
Drugs or methodologies used to make a body area free of sensation or pain.

Mentioned in: Appendectomy
 and audible alarms set at the minimum level. This is not how anesthesia professionals routinely practice," said Dr. Kelley. "We would expect that a protocol which provides significant amounts of volatile anesthesia would produce a low incidence of awareness in these patients."

In practice, anesthesia professionals use clinical judgment, monitoring methods and preferences to select and dose a variety of anesthetic mediations to ensure that their patients are unconscious and free of pain during surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. . A growing number of anesthesia clinicians also use brain monitoring information to help adjust the amount of anesthetic medication during surgery to personalize anesthetic care based on each patient's unique responses.

"We believe that a protocol-based approach providing a certain amount of anesthetic to every patient would reduce the control and flexibility that anesthesia professionals depend upon to provide the best care," said Dr. Kelley. "Anesthesia professionals are responsible for a quick recovery and mitigating post-operative pain as well as managing anesthesia care during surgery. An individualized in·di·vid·u·al·ize  
tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es
1. To give individuality to.

2. To consider or treat individually; particularize.

3.
 approach to patient care helps optimize these post-operative outcomes."

The NEJM study adds to the large body of evidence investigating the BIS monitor. A rigorous evidence-based review conducted by the Cochrane Collaboration The Cochrane Collaboration was developed in response to Archie Cochrane's call for up-to-date, systematic reviews of all relevant randomized controlled trials of health care.  demonstrates the broad clinical benefits of BIS monitoring. The Cochrane review analyzed 20 randomized controlled trials in which BIS-guided care was compared with standard practice and documented the positive impact of BIS monitoring in reducing anesthetic drug consumption, improving recovery and helping clinicians reduce the risk of awareness. In another meta-analysis of 12 studies, the author estimated that the reduction in drug use and improved recovery reduced the net cost of BIS monitoring to approximately $5.50 per case. "When considering the overall costs for a surgical procedure, this small additional cost to utilize BIS monitoring delivers significant value when considering the safety impact for reducing awareness as well as the choice, flexibility, and information it provides to the anesthesia professional delivering high quality patient care," said Dr. Kelley.

More information about the NEJM trial, including a more detailed comparison with the B-Aware trial can be found at Aspect's Web site at www.aspectmedical.com.

Aspect includes in this press release links to its Web site. Aspect cautions you that the information on its 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 25 million patients and has been the subject of more than 3,100 published articles and abstracts. BIS technology is installed in approximately 80 percent of hospitals listed in the July 2007 U.S. News and World Report ranking of America's Best Hospitals America's Best Hospitals Media & health An annual 'report card' on the quality of care received in US hospitals published by US News & World Report, that is either proudly quoted by those who are rated or dismissed by those who are not  and in approximately 60 percent of all U.S. operating rooms. In the last twelve months BIS technology was used in approximately 17 percent of all U.S. surgical procedures requiring general anesthesia Anesthesia, General Definition

General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs.
 or deep sedation Sedation Definition

Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm.
Purpose

The process of sedation has two primary intentions.
. BIS technology is available in more than 160 countries. Aspect Medical Systems has OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and  agreements with eight leading manufacturers of patient monitoring systems. For more information, please visit the Aspect Medical Systems Web site www.aspectmedical.com.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
. 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. 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. There are other factors that could cause the Company's actual results to vary from its forward-looking statements, including without limitation those factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended September 29, 2007, which is on file with the SEC.

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.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

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Publication:Business Wire
Article Type:Clinical report
Date:Mar 12, 2008
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