Covidien announces US FDA clearance of Nellcor respiration rate
18 April 2012
Covidien has announced FDA has granted 510(k) clearance to
market the Covidien Nellcor Respiration Rate Version 1.0 software and
the Adult Respiratory Sensor.
Covidien gained CE Mark in 2011 and began to market it throughout
the European Economic Area. The Company plans a limited market
release in the US, starting this month, which will allow select
hospitals to be the first to use the new technology.
“Respiration rate is a critical vital sign that can be the first
indicator of a change in patient condition that may require
immediate assessment or intervention,” said Scott Kelley, MD, Chief
Medical Officer, Respiratory and Monitoring Solutions, Covidien.
“Despite its clinical importance, current methods of respiration
rate monitoring are not always adequate. The addition of Respiration
Rate to the Covidien Nellcor Respiratory Function portfolio provides
a more holistic monitoring solution using a single, integrated
"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 healthcare professionals a more
complete picture of a patient’s respiratory status, so they can
provide effective treatment and maintain patient safety.”
“We are pleased to receive 510(k) clearance to market the new
Covidien Nellcor Respiration Rate software in the United States.
This important milestone reflects Covidien’s commitment to continued
innovation in patient monitoring to improve clinician efficiency,
respiratory care and patient safety,” said Robert J. White,
President, Respiratory and Monitoring Solutions.
Continuous monitoring of respiration rate is especially important
for adult patients receiving medication for post-operative pain
management, who are at increased risk for respiratory complications.
New conclusions and recommendations from the Anesthesia Patient
Safety Foundation (APSF) suggest continuous electronic monitoring of
oxygenation and ventilation for these patients to reduce the risk of
unrecognized, clinically significant respiratory complications.
The APSF also recommends that continuous monitoring should
integrate multiple physiologic parameters to detect clinically
significant respiratory changes earlier and more reliably.1 The
Covidien Nellcor Respiration Rate software may help clinicians meet
APSF’s recommendations for managing this patient population.