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Covidien plc (COV) Announces FDA 510(k) Clearance of Nellcor™ Respiration Rate Software

3/20/2012 7:05:24 AM

BOULDER, Colo.--(BUSINESS WIRE)-- Covidien (NYSE: COV - News), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Company to market the Covidien Nellcor™ Respiration Rate Version 1.0 software and the Adult Respiratory Sensor.

In late 2011, Covidien labeled the respiratory monitoring platform with the CE Mark and began to market it throughout the European Economic Area. The Company plans a limited market release in the U.S., starting next 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 sensor. 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.”

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.

“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.


Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit to learn more about our business.

1 Anesthesia Patient Safety Foundation. Essential Monitoring Strategies to Detect Clinically Significant Drug-Induced Respiratory Depression in the Postoperative Period. Conclusions and Recommendations. Accessed September 28, 2011.


For Covidien

Rhonda Luniak, 303-406-8743

Vice President

R&MS Communications


Bruce Farmer, 508-452-4372

Vice President

Public Relations


Coleman Lannum, CFA, 508-452-4343

Vice President

Investor Relations


Todd Carpenter, 508-452-4363


Investor Relations

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