Healthcare Industry News: Edwards Lifesciences
News Release - April 16, 2009
Somanetics Announces New FDA 510(K) ClearanceLabeling expanded to include improved patient outcomes and real-time measurement accuracy
TROY, Mich., April 16 (Healthcare Sales & Marketing Network) -- Somanetics Corporation (Nasdaq: SMTS ) announced today a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOSŪ Cerebral/Somatic Oximeter. The new labeling allows a claim of improved patient outcomes after surgery when the INVOS System is used to manage therapies in patients above 2.5 kilograms (kg) at risk for reduced or absent blood flow. Additionally, its indications for use now reflect the INVOS System's ability to generate accurate real-time measurements of blood oxygen saturation in this same patient population, in addition to its previous clearance as a trend monitor in any individual.
These changes make the INVOS System the only commercially-available cerebral/somatic oximeter backed by an improved patient outcomes claim, and the only cerebral/somatic system cleared for use on neonates less than 2.5 kg.
The INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter noninvasively monitors site-specific blood oxygen levels to help surgical and critical care teams protect their patients against brain and vital organ area damage, or even death.
"The clinical data we submitted and subsequent 510(k) clearance demonstrate that improved patient outcomes are possible with the use of our INVOS System, and that our device can benefit cardiac surgery patients as well as high-risk general surgery patients, such as the elderly undergoing major abdominal surgery," explains Bruce Barrett, Somanetics' president and CEO.
Marc S. Kanchuger, MD, Associate Professor and Chief of Cardiothoracic Surgery and Transplant Anesthesia at NYU Medical Center adds, "I'm not surprised by the FDA's decision. We use the INVOS System routinely in all our cardiac surgeries in an effort to protect patients from ischemic brain complications. I suspect today's news will spark further adoption of the technology by the medical community."
Barrett continues, "Our expanded indication reinforces the device's applicability for on-label treatment of patients at any weight. For patients above 2.5 kilograms, including adults, children and most infants, our proprietary algorithm generates accurate, real-time measurements for immediate use by the care team. In patients below 2.5 kilograms, which is extremely common in our neonatal market, clinicians may use our device on-label as a trend monitor."
The labeling also removed "not demonstrated in disease states" from the indication for patients weighing greater than 2.5 kg, and includes additional 510(k) language on these three points:
- The measurement of regional cerebral oxygen saturation (rSO2) is an indication of whether oxygen delivery to the brain is adequate. Prolonged declines in rSO2 are indicative of, or may result in, potential brain injury.
- When used as an indication of compromised cerebral oxygenation, interventions to return the patient's rSO2 to baseline using the INVOS System have been shown to improve outcomes after surgery.
- In neonates, infants and children, cerebral and somatic rSO2 provide noninvasive indications of oxygen changes in the cerebral and peripheral circulatory systems and may provide an early indication of oxygen deficits associated with impending shock states and anaerobiosis.
Somanetics Corporation (Nasdaq: SMTS ) develops, manufactures and markets the INVOSŪ 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 in patients above 2.5 kilograms, and is the only cerebral/somatic oximeter system cleared for use on neonates less than 2.5 kg. 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 600 clinical references and implementation at more than 700 U.S. hospitals. Somanetics also is developing a technology 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 South Africa and Edwards Lifesciences represents INVOS System products in Japan. For more information visit www.somanetics.com.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.