TROY, Mich., Oct. 14 /PRNewswire-FirstCall/ -- Somanetics Corporation (Nasdaq: SMTS) today announced that it has signed
Somanetics plans to utilize this patent-pending method of combining blood pressure measurements and signals from the INVOS System to continuously monitor and display cerebral autoregulatory function information. Somanetics plans to file a new 510(k) pre-market notification with the FDA to support marketing the new module in the U.S. by late 2010 and initiate product shipments for sale early in 2011.
Cerebral autoregulation refers to the body’s ability to maintain constant blood flow to the brain despite changes in blood pressure. In many critical care situations, the brain’s autoregulation can become impaired, making it vulnerable to changes in blood pressure and to potential brain injury due to loss of this critical protective mechanism. For example, blood pressure below the patient’s autoregulation threshold can result in cerebral ischemia, while blood pressure above the patient’s upper limit of autoregulation can result in cerebral bleeding.
Patients at highest risk of impaired cerebral autoregulation include those undergoing certain surgical procedures, such as cardiovascular, neurological and major orthopedic procedures, and liver transplants. Others at risk include patients with traumatic brain injury, those who have suffered a stroke, infants on ventilators and premature babies.
“Adding the ability to noninvasively assess the state of cerebral autoregulation to the INVOS System’s existing measurement of brain oxygen saturation should enhance the value proposition for the INVOS System, increase our market potential by supporting entry into new clinical applications and strengthen our leadership position in the growing oximetry market,” said Bruce Barrett, Somanetics’ president and chief executive officer. “We believe the noninvasive approach of assessing cerebral autoregulation with the INVOS System may make the measurement simple enough to support routine clinical use and potentially prevent neurologic injury to patients.”
Co-inventor of the autoregulation technology, Kenneth Brady, M.D., pediatric intensive-care specialist at The Johns Hopkins Children’s Center and assistant professor in the Division of Pediatric Critical Care and Anesthesiology, has published his research findings on this topic in Stroke, Anesthesia & Analgesia and Contemporary Critical Care.
Brady’s research findings demonstrate that the range of mean arterial blood pressure traditionally taught and associated with intact cerebral autoregulation does not apply to all patients.
“Physicians are largely taught that cerebral autoregulation is intact as long as mean arterial blood pressure remains between 50-150 millimeters of mercury,” explains Michael D. Wider, PhD, Somanetics’ vice president of technology and market development. “However, growing evidence suggests that many critically ill patients – or even younger, healthier patients undergoing surgical procedures – do not autoregulate as we thought, putting them at risk of adverse events.”
“This patient variability has been under-recognized, in part due to lack of practical ways to evaluate it,” continues Wider. “Current methods require monitoring of intracranial pressure involving invasive access to the brain, or are not designed for continuous monitoring, and therefore are not routinely used. This new approach involving the INVOS System provides continuous data on cerebral autoregulation without intracerebral pressure monitoring so physicians can readily define each patient’s requirements and optimize blood pressure to improve outcomes.”
Increasing awareness of patient variability in autoregulation is fueling discussions on patient-specific blood pressure targets and management techniques. Data supporting Brady’s cerebral autoregulation technology will be presented at the American Society of Anesthesiologists (ASA) annual conference this month. In addition, the Anesthesia Patient Safety Foundation is hosting a physician workshop related to the topic of autoregulation prior to the ASA, and also dedicated its Spring/Summer 2009 newsletter to it.
Somanetics Corporation (Nasdaq: SMTS) develops, manufactures and markets the INVOS® Cerebral/Somatic Oximeter which noninvasively provides accurate, real-time blood oxygen measurements in patients greater than 2.5 kilograms, and trend monitoring of this parameter for individuals of any weight. The INVOS System is the only commercially-available cerebral/somatic oximeter proven to improve outcomes. Surgeons, anesthesiologists and other medical professionals can use data provided by the INVOS System, in conjunction with other available data, to identify oxygen imbalances in brain or other body tissue beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care.
The INVOS System is the clinical reference standard in cerebral/somatic oximetry, with an 11-year market track record, more than 750 clinical references and implementation at more than 750 U.S. hospitals. Somanetics also develops, manufactures and markets the Vital Sync™ System, a device that integrates data from bedside devices into a single system for enhanced patient assessment and decision making, data management and data storage. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Covidien markets INVOS System products in Europe, Canada, the Middle East and 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, including the recent global economic crisis, 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 INVOS Cerebral/Somatic Oximeter and disposable sensors, our dependence on distributors 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, 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 income, changes in accounting rules, enforceability and the costs of enforcement of our patents, potential infringements of others’ patents, the effect of acquisitions and the other factors set forth from time to time in Somanetics’ Securities and Exchange Commission filings, including Somanetics’ 2008 Annual Report on Form 10-K filed on February 11, 2009 and its 2009 Quarterly Reports on Form 10-Q filed on March 31, 2009, July 1, 2009 and September 28, 2009.
SOURCE Somanetics Corporation
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