Aspect Medical Systems Features Anesthesia Outcomes Research, New Products at American Society of Anesthesiologists Annual Me...
19 10월 2009 - 9:00PM
Business Wire
The American Society of Anesthesiologists (ASA) Annual Meeting
will feature 62 scientific presentations that reference BIS®
monitoring when it convenes on October 17-21, 2009 in New Orleans.
BIS-related research will cover a broad range of applications for
BIS monitoring, including initial results from studies conducted as
part of a comparative effectiveness research collaboration with the
Cleveland Clinic as well as findings from a study evaluating use of
a Composite Variability Index (CVI) that is based on BIS
parameters. Aspect Medical Systems, Inc. (NASDAQ: ASPM) will also
present a complete family of BIS monitoring technologies, enhanced
BIS education and simulation technology and the new LiDCOrapid
advanced hemodynamic monitoring system.
“A significant amount of research related to the importance of
assessing both brain and cardiovascular response to anesthesia is
being presented and discussed this year at the ASA meeting,” said
Scott Kelley, MD, vice president of medical affairs for Aspect
Medical Systems. “We are pleased that innovative technologies and
individualized approaches to optimizing anesthesia care continue to
be an area of broad clinical interest.”
Outcomes research highlights
Eight abstracts presenting preliminary results from Aspect’s
comparative effectiveness research collaboration with the Cleveland
Clinic will be presented this week. This includes research that
focuses on identification of specific intraoperative events and
interventions that are associated with adverse patient outcomes. A
key finding from this research suggests that a “triple low” of low
blood pressure, BIS values and minimum alveolar concentration (MAC)
of inhalational anesthesia is associated with poorer postoperative
recovery and increased risk of mortality at 30 days and at one
year. Furthermore, early intervention with vasopressors appears to
reduce much of this harm in retrospective analysis.
“This research reinforces the important role that anesthetic
management decisions play in enabling better patient outcomes,”
said Kelley. “We believe that this presents a significant
opportunity to further define interventions and decision support
systems that will lead to additional improvements in clinical
practice and patient outcomes.”
Other research related to the Cleveland Clinic collaboration
evaluates use of objective “risk stratification” methodologies to
compare patient records from more than 85,000 surgical patients
treated at Cleveland Clinic with a baseline risk assessment system
derived from 34 million patient records obtained from the Center
for Medicare and Medicaid Services (CMS). Results indicate that the
risk stratification methodologies provide an objective method for
hospitals to compare individual results on a risk- and
case-adjusted basis using readily available billing and demographic
data. The risk stratification indices also performed well in
predicting in-hospital mortality and length of stay.
“In the current healthcare environment, hospitals are
increasingly required to publicly report surgical outcomes.
However, these reports can only be interpreted in the context of
the underlying risk of a hospital’s patient population,” said
Daniel I. Sessler, MD, professor and chair, Department of Outcomes
Research at Cleveland Clinic. “The preliminary data from these
studies suggests that we have found a way to quantify the risk of a
surgical patient in a given hospital and compare this risk with
observed outcomes. For example, our patient population was
considerably sicker than a matched Medicare population, but also
significantly less likely to experience complications or die —
either in the hospital or in the days and months following surgery.
The ability to accurately risk-stratify surgical patients is
critical given the growing emphasis on quality and performance
measures in healthcare.”
Other Aspect-supported research being presented at ASA includes
four abstracts that address how variability in EEG parameters may
be useful in assessing patient nervous system response to surgical
stimulation during anesthesia. This research is part of a
development program for a Composite Variability Index (CVI) that
provides an indicator of analgesic adequacy. Results from this
prospective, multicenter study (the ADVANCE study) show that CVI
was able to detect the likelihood of a somatic event, such as
patient movement in response to surgical stimulation, earlier than
cardiovascular measures. Study results also show that CVI performed
well with both inhalational and intravenous anesthetic
techniques.
Products and education programs designed to help optimize
outcomes
In addition to presenting the complete family of BIS monitors,
sensors and modular solutions, Aspect will introduce the new
LiDCOrapid monitoring system, a minimally invasive cardiac output
monitor designed for use in the operating room to provide
clinicians with accurate and immediate feedback on the patient's
fluid and hemodynamic status. The LiDCOrapid system, comprised of a
monitor and single-use disposable, provides flow-based hemodynamic
monitoring information that is ideally suited for high risk
patients and procedures or when optimal fluid management requires
more information than can be obtained from standard blood pressure
data alone.
“A growing body of research, including research from our
collaboration with the Cleveland Clinic, suggests that measuring
both brain and cardiovascular responses is necessary to optimize
patient management and achieve the best patient outcomes,” said
Kelley. “We believe that the BIS and LiDCO technologies are highly
complementary and we are pleased to introduce this new offering to
our customers.”
Aspect will also present a complete suite of BIS education
resources including an enhanced “BIS Titration SimulatOR” that
allows clinicians to practice titrating anesthetic agents to
achieve a target BIS range while maintaining stable
hemodynamics.
About BIS Monitoring: Using a sensor placed on the
patient’s forehead, BIS monitoring translates information from the
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 LiDCOrapid: LiDCOrapid is a minimally invasive
hemodynamic monitoring system designed specifically for use in the
operating room. The system acquires continuous blood pressure data
from an existing arterial line, which is placed today in
approximately 15% of surgical patients, and uses a proprietary
“PulseCO” algorithm to calculate parameters related to functioning
of the patients’ circulatory system. Anesthesia professionals use
these parameters to help guide intraoperative management of the
patient and ensure the patient is receiving optimal fluid volume in
the bloodstream. Aspect sells the LiDCOrapid monitoring system in
the U.S. pursuant to its exclusive distribution and licensing
agreement with LiDCO Group plc. More information about the
LiDCOrapid can be found at http://www.aspectmedical.com.
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 34 million patients and has been the subject of more
than 3,300 published articles and abstracts. BIS technology is
installed in approximately 78 percent of hospitals listed in the
July 2009 U.S. News and World Report ranking of America's Best
Hospitals and in approximately 74 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. Aspect Medical Systems has OEM
agreements with nine leading manufacturers of patient monitoring
systems. For more information, visit Aspect's Web site at
http://www.aspectmedical.com.
Cautionary Statement Regarding 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. These statements
include the Company’s expectations that the findings from its
comparative effectiveness research with and the Cleveland Clinic
could lead to additional improvements in clinical practice and
patient outcomes. 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 and Cleveland Clinic may not generate beneficial data from
their ongoing comparative effectiveness research program, and
favorable data in preliminary results may not be replicated in
later findings. 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. The Company also faces competitive and
regulatory risks relating to its ability to successfully develop
and introduce enhancements and new products, such the LiDCOrapid
monitoring system that it recently began selling in the U.S. In
addition, the Company’s ability to remain profitable will depend
upon its ability to promote frequent use of the BIS system so that
sales of its BIS sensors increase. The Company will not remain
profitable if hospitals and anesthesia providers do not buy and use
its BIS systems in sufficient quantities. 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 may not be able to control expenses
or grow its sales force as planned. There are other factors that
could cause Aspect’s actual results to vary from its
forward-looking statements, including without limitation those set
forth under the heading “Risk Factors” in Aspect’s Annual Report on
Form 10-K for the year ended December 31, 2008 and Aspect’s
Quarterly Report on Form 10-Q for the fiscal quarter ended July 4,
2009, and other filings made by the Company 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, BIS and BISx are trademarks
of Aspect Medical Systems, Inc. and are registered in the USA, EU
and other countries. BIS VISTA and BIS VIEW are trademarks of
Aspect Medical Systems, Inc. LiDCO is a registered trademark of
LiDCO Limited. All other trademarks, service marks and company
names are the property of their respective owners.
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