Healthcare Industry News: Edwards Lifesciences
News Release - September 13, 2007
The Society of Thoracic Surgeons Adds Cerebral Oximetry as Metric to STS Adult Cardiac Surgery DatabaseTROY, Mich., Sept. 13 (HSMN NewsFeed) -- Medical device maker Somanetics Corporation (Nasdaq: SMTS ) today announced that The Society of Thoracic Surgeons (STS) has added cerebral oximetry as a metric to be collected as part of the STS Adult Cardiac Surgery Database effective January 1, 2008.
Somanetics' INVOS System is a cerebral oximeter that helps medical professionals protect patients during cardiac surgery by reflecting whether the brain has adequate oxygenation throughout the operation.
"The STS' decision to incorporate cerebral oximetry into its database supports our company's evidence-based philosophy with regards to demonstrating the role of technology to potentially improve patient outcomes," states Bruce J. Barrett, president and CEO of Somanetics. "We are excited that cerebral oximetry will be a part of this quality initiative."
To date, there are more than 500 published clinical papers, abstracts and conference presentations evaluating the benefits of cerebral oximetry via the INVOS System. These include studies showing a correlation with reduction of stroke, major organ morbidity and mortality, post-op cognitive difficulties, adverse cardiac events, respiratory failure and ventilator time. Data has shown that reducing these surgical complications correlates with decreased patient length of stay in the post-op intensive care unit - one of the most costly care areas - as well as the overall length of hospital stay.
"The clinical popularity of cerebral oximetry seems to merit inclusion in the STS database," explains Nicholas J. Gawrit, president of heartbase inc., a clinical registry reporting firm whose software is certified by STS for use by Adult Cardiac Surgery Database participants. "The addition of this metric to the database is an opportunity to validate the outcome benefit of patient management guided by cerebral oximetry in thousands of patients."
According to the STS, the STS Adult Cardiac Surgery Database is the largest cardiothoracic surgery outcomes and quality improvement database program in the world, and is viewed as the national gold standard for cardiothoracic surgery. Over 800 surgeon groups voluntarily participate in this clinical registry containing data from more than three million patient records.
This data is considered the cornerstone of quality assessment in cardiothoracic surgery and has been used to establish clearly-defined benchmarks for clinical comparisons. Many third-party payers, major corporate purchasers of healthcare, hospitals, health care systems and states now require monitoring of outcomes and participation in quality improvement programs, and involvement in the STS National Database helps fulfill this requirement.
Somanetics has pioneered many "firsts" in the regional oximetry market, including the first U.S. adult cerebral oximeter in 1996, the first pediatric cerebral oximeter in 2000 and the first simultaneous cerebral-somatic (brain and body tissue) oximeter in 2005.
About the INVOSŪ Cerebral / Somatic Oximeter
The INVOS System has a 10-year market track record and is used at more than 600 U.S. hospitals conducting a total of 150,000 procedures annually. It is the only noninvasive oximeter to provide simultaneous cerebral/somatic monitoring of changes in regional blood oxygen saturation. The INVOS System uses near infrared spectroscopy to "reflect the color of life" by measuring the color of de-oxygenated and oxygenated hemoglobin molecules within red blood cells. The resulting regional oxygen saturation (rSO2) change information is a vital sign that helps critical care teams detect and correct site-specific blood oxygenation issues that can lead to complications and poor outcomes. Cerebral/somatic monitoring via the INVOS System can be used on adult, pediatric and infant patients in any clinical setting where patients are at risk of reduced-flow or no-flow ischemia.
Somanetics Corporation (Nasdaq: SMTS ) develops, manufactures and markets the INVOS Cerebral/Somatic Oximeter, a non-invasive patient monitoring system that continuously measures changes in the blood oxygen levels in the brain and body (i.e., somatic, or skeletal muscle tissue). Surgeons, anesthesiologists, intensive care nurses and other medical professionals can use the information provided by the INVOS System, in conjunction with other available information, to identify cerebral or somatic oxygen imbalances and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Tyco Healthcare markets INVOS System products in Europe, Canada, the Middle East and South Africa and Edwards Lifesciences represents INVOS System products in Japan. For more information visit www.somanetics.com.
Except for historical information contained herein, the matters discussed in this news release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Actual results may differ significantly from results discussed in the forward-looking statements and may be affected by, among other things, economic conditions in general and in the healthcare market, the demand for and market acceptance of our products in existing market segments and in new market segments we plan to pursue, our current dependence on the Cerebral Oximeter and SomaSensor, our dependence on distributors and independent sales representative firms for a substantial portion of our sales, our dependence on single-source suppliers, potential competition, the effective management of our growth, our ability to attract and retain key personnel, the potential for products liability claims, government regulation of our business, changes in our deferred tax assets, future equity compensation expenses, the challenges associated with developing new products and obtaining and maintaining regulatory approvals if necessary, research and development activities, the lengthy sales cycle for our products, sales employee turnover, changes in our actual or estimated future taxable income, changes in accounting rules, enforceability and the costs of enforcement of our patents, potential infringements of others' patents and the other factors set forth from time to time in Somanetics' Securities and Exchange Commission filings, including Somanetics' 2006 Annual Report on Form 10-K filed on February 8, 2007 and the first and second quarter 2007 Quarterly Reports on Form 10-Q filed on April 3, 2007 and June 29, 2007 respectively.
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