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American Society of Anesthesiologists Adopts Practice Advisory on Intraoperative Awareness and Brain Function Monitoring

Posted on: Tuesday, 25 October 2005, 15:01 CDT

Aspect Medical Systems (NASDAQ: ASPM) today announced that the American Society of Anesthesiologists (ASA) House of Delegates has approved a practice advisory for clinicians that addresses intraoperative awareness and the role of brain function monitoring, including Aspect's BIS technology. Intraoperative awareness occurs when patients do not receive enough anesthesia to remain unconscious, leaving them at risk of becoming aware of what is happening and remembering this experience after the surgery is over. The practice advisory is designed to provide guidance to anesthesiologists regarding this important safety concern and was approved at the ASA annual meeting in Atlanta, Georgia today.

"The ASA approval of this document represents a significant step forward in addressing intraoperative awareness and the role of brain function monitoring and reinforces the society's leadership in advancing patient safety," said Nassib Chamoun, president and CEO of Aspect. "We believe that the guidance provided by the ASA, combined with the Sentinel Event Alert issued to healthcare facilities by the Joint Commission on Accreditation of Healthcare Organizations, supports the need for healthcare facilities to make brain monitoring available in every operating room that serves patients at risk for awareness."

Practice Advisory Guidance to Clinicians

The practice advisory acknowledges the reported incidence of intraoperative awareness of one to two cases per thousand patients receiving general anesthesia. The document also recognizes the significant psychological harm that some patients may experience following an episode of awareness. To address this safety concern, the advisory document states that:

-- Patients should be evaluated for awareness risk factors.

-- Those patients identified as at risk should be informed and anesthetic depth should be monitored using multiple modalities.

-- Although brain function monitoring is not indicated for use on all patients undergoing general anesthesia, the decision to use brain function monitoring for selected patients should be made by individual practitioners on a case-by-case basis. The Advisory reports that the majority of ASA members (69%) surveyed believe that brain function monitoring is valuable and should be used to help reduce the incidence of awareness in patients at risk.

-- Appropriate patient follow up should be conducted in patients who report awareness, including assessment, reporting and counseling.

According to the practice advisory, clinicians should conduct a preoperative evaluation to identify patients at risk for intraoperative awareness. The report cites studies and case reports that suggest that certain patient characteristics, surgical procedures and anesthesia techniques may be associated with an increased risk of awareness. Potential risk factors for awareness listed in the report include:

-- Substance use or abuse;

-- Patient history of awareness;

-- Difficult intubation;

-- Cardiac surgery, Cesarean section, trauma and emergency surgery;

-- Reduced anesthetic doses in the presence of paralysis;

-- Use of muscle relaxants; and

-- Total intravenous anesthesia (TIVA) and other anesthesia techniques.

Clinical Evidence Supporting BIS Monitoring

The ASA practice advisory provides documentation that BIS is the only brain monitoring technology or clinical intervention that has been shown in large scale, prospective clinical research to reduce the incidence of awareness. Specifically, research cited in the ASA practice advisory (and published in The Lancet in May 2004) 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 Food and Drug Administration (FDA) granted clearance for BIS monitoring being associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. This is the only technology to receive this type of clearance from FDA.

"This ASA document provides a pathway for caring for patients who may experience awareness and elevates the role of brain function monitoring to a new position of importance within anesthesia practice," said Scott Kelley, MD, Aspect's medical director and a practicing anesthesiologist. "When clinicians evaluate the strength of the data supporting BIS technology and consider the lack of evidence for other practice interventions and monitoring modalities, we believe that they will recognize the patient safety benefits of BIS technology and move toward broader utilization of BIS monitoring as an adjunct to conventional monitoring."

Aspect will post a commentary providing additional details about the advisory on the company Web site (http://www.aspectmedical.com) following public disclosure of the advisory by the ASA.

Aspect Conference Call

As announced last week, Aspect Medical Systems will host a conference call and live Webcast tomorrow, October 26, 2005 at 12:00 p.m. ET to discuss the advisory. To participate in the call, please dial 1-800-289-0494 (domestic), 1-913-981-5520 (international), or access the Webcast at www.aspectmedical.com on the Investor page or at www.earnings.com. Telephone replays will be available by dialing 1-888-203-1112 (domestic), or 1-719-457-0820 (international), access code 9419112. The Webcast replay will be available from October 26, 2005, 3:00pm ET until November 2, 2005.

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. To date, the company's Bispectral Index (BIS) technology has been used to assess more than 12.2 million patients and has been the subject of approximately 2,000 published articles and abstracts. BIS technology is installed in approximately 68 percent of hospitals listed in the July 2005 U.S. News and World Report ranking of America's Best Hospitals and in approximately 40 percent of all domestic operating rooms. In the last twelve months, BIS technology was used in approximately 12% 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 seven leading manufacturers of patient monitoring systems. The company is also investigating how other methods of analyzing brain waves may aid in the diagnosis and management of neurological diseases, including depression and Alzheimer's disease. For more information, visit Aspect's web site at http://www.aspectmedical.com.

Safe Harbor Statement

Certain statements in this release are forward-looking and may involve risks and uncertainties, including statements regarding the Company's expectation that the ASA's guidance concerning intraoperative awareness and the role of brain function monitoring should have the effect of accelerating the adoption of BIS monitoring and will support efforts to improve the safety and quality of anesthesia care. 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, the Company may not achieve widespread market acceptance of its BIS monitoring technology among anesthesiologists, including members of the ASA who review the practice advisory statement. The Company also faces other barriers to market penetration and acceptance. The Company may not be able to compete with new products or alternative techniques that may be developed by others, including third-party anesthesia monitoring products approved by the FDA, and also faces competitive and regulatory risks relating to its ability to successfully develop and introduce enhancements and new products. 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 additional 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 "Factors Affecting Future Operating Results" in the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2005, as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent the Company's views only as of the date of this press release and should not be relied upon as representing the Company's views as of any subsequent date. While the Company 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 the Company'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.

Source: Business Wire

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