The Mansfield, Mass.-based med-tech titan is preparing a limited market release in the U.S. next month, allowing select hospitals to use the Nellcor system, according to a press release.
"Despite its clinical importance, current methods of respiration rate monitoring are not always adequate," Dr. Scott Kelley, Covidien’s chief medical officer, said in prepared remarks. "Instead of merely knowing a patient’s blood oxygen levels, we can now look at aspects of ventilation, or the passing of air into and out of the body. This gives health care professionals a more complete picture of a patient’s respiratory status, so they can provide effective treatment and maintain patient safety ."
The Nellcor system tracks changes in patients’ pulse oximetry signals to determine respiration rate changes, allowing clinicians to head off potentially life-threatening respiratory problems. Covidien won CE Mark approval to launch the device in the European Union in December 2011.
News of the CE Mark sent COV shares up 4%, but there hasn’t been a complementary response to the FDA win on Wall Street. COV shares were flat at $53.73 as of about noon today.
The device maker recently posted a record-breaking quarter with adjusted gross margins of 58.8% for the 3 months ended Dec. 24, 2011, 1.2 points higher than during the same period in 2010.
Covidien also upped its 2012 fiscal guidance, forecasting 3% to 5% sales growth. Its previous guidance was about a point lower.