CAS is 2nd company to win U.S. cerebral oximeter okay
Diagnostics & Imaging Week Associate
With its FDA 510(k) clearance last week, CAS Medical Systems (Branford, Connecticut) became the second company to have a cerebral oximeter monitor approved for sale on the U.S. market.
The company s Near Infrared Spectroscopy (NIRS) Adult Cerebral Oximeter Monitor is a continuous, non-invasive monitor that measures absolute levels of brain tissue oxygen saturation.
CAS oximeter approval follows that of Somanetics (Troy, Michigan) with its Invos Cerebral Oximeter to gain an approval for this type of device in the U.S. The company said it plans launch sometime in late 2006.
Earlier in the month, CAS, founded in 1984, reported that Nasadaq had approved the company s application for listing its common stock on the Nasdaq SmallCap Market under the symbol CASM.
Andrew Kersey, the company s chief operating officer, said the timing of the Nasdaq listing was coincidental and that all CAS business segments, which include blood pressure measurement technology, vital signs monitoring equipment, apnea monitoring equipment and products for neonatal intensive care, are doing quite well
I think we ve seen significant improvement in the core business, Kersey told Diagnostics & Imaging Week. We re seeing growth and improvement in all areas [of our business] at this moment. The timing of the Nasdaq listing was purely to do with the company performance over the past couple of years.
The CAS Cerebral Oximeter utilizes the company s optically based NIRS technology, which was developed with the help of a series of Small Business Innovative Research (SBIR) grants from the National Institutes of Health (Bethesda, Maryland).
Results from a study conducted by Duke University Medical Center (Durham, North Carolina), detailing the performance of the CAS oximeter, were presented at the American Society of Anesthesiologists (Park Ridge, Illinois) annual meeting in Atlanta in October.
According to Kersey, the cerebral oximeter is similar to the ubiquitous pulse oximeter in the sense that it s an optical-based technique using fairly similar wavelengths of light.
What differentiates the CAS cerebral oximeter, other than the fact that it does not require a pulse to make readings, is the fact that it uses four lasers to gain a signal in contrast to a pulse oximeter that generally uses two light-emitting diodes.
Since the cerebral oximeter does not require a pulse to measure brain oxygenation, Kersey said that it has several advantages, particularly in the operating room (OR).
Certainly that s true in cardiac surgery, where the heart can be on bypass, and thus no pulse is available to make readings. The other significant advantage, he said, is the fact that the brain is really what you re interested in. Measuring the oxygen concentration in your fingertip [as is done with pulse oximetry] is nice, but really doesn t tell you what s going on in the most critical organ. [Pulse] oximeters monitor the amount of oxygen that you re delivering into the bloodstream, but that doesn t necessarily tell you that it s actually getting to the brain.
Louis Scheps, president and CEO of CAS Medical, called the oximeter approval a milestone for the company. He noted that the initial market for the product would be in the OR, for use in high-risk procedures such as cardiac surgery, carotid surgery and neurosurgery.
The CAS oximeter will give healthcare providers absolute, accurate, real-time information to guard against neurological injuries due to compromised brain oxygenation that can occur during many surgical and clinical procedures, Scheps said. We believe it may also assist in important clinical decisions in post-operative intensive care units.
In the OR the device, which consists of monitoring system incorporating measurement software and measurement display, is attached to the patient s head via sensors. Generally the anesthesiologist is the person in the OR setting monitoring the preset thresholds that are customized to the individual patient. It is up to the anesthesiologist to determine whether brain oxygenation has been compromised and to correct the problem either by changing ventilation, increasing oxygen or CO2 intake or tilting the patient s neck back.
According to Kersey, it has actually been the surgeons who have championed the use of these cerebral oximeters in the OR setting, because they can contribute to much better patient outcomes and can lessen the chance of severe adverse cerebral outcomes such as stroke, coma or potentially even death.
While he noted that the company s aforementioned target areas in the OR are potentially quite lucrative by themselves, he believes that the system can ultimately become the standard of care for virtually all OR procedures.
In November, competitor Somanetics received 510(k) clearance to market the Invos technology to monitor changes in blood oxygen saturation in regions of the body other than the brain.
This new application of the Invos technology is intended as an adjunct trend monitor of hemoglobin oxygen saturation of blood in skeletal muscle tissue beneath the sensor in infants, children and adults at risk of reduced- flow or no-flow ischemic states in critical care settings.