Covidien Receives FDA Clearance For The Nellcor™ OxiMax™ N-600x™ Pulse Oximeter With OxiMax SPD™ Alert

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 24 Mar 2009 - 7:00 PDT

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Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that the United States Food and Drug Administration (FDA) has issued a 510(k)marketing clearance for the Nellcor™ OxiMax™ N-600x™ pulse oximeter with OxiMax SPD™ alert for adults. The OxiMax SPD feature enables the pulse oximeter to detect and alert clinicians of worrisome oxygen desaturation patterns, allowing them to make timely and more informed decisions about patient care.

"Demand for continuous pulse oximetry monitoring - especially for patients on opioids - is increasing across all areas of the hospital and is a vital part of balancing patient safety and pain management," said Roger Mecca, M.D., Vice President, Medical Affairs, Respiratory and Monitoring Solutions, Covidien. "With the recently granted FDA clearance, Covidien introduces a new alert technology that allows us to provide early warnings of physiological conditions that may lead to respiratory issues. This enables clinicians to intervene earlier and help improve outcomes."

Detecting repetitive reductions in airflow is a vital measure of a patient's respiratory status and requires close monitoring in higher risk patients, such as those:

- Recovering from surgery
- Being treated with pain medications
- Diagnosed with sleep apnea
- With a high body mass index
- Who are elderly

Recent research indicates that respiratory depression is the number one reason for code emergencies in hospitals today.1 Repeated drops in oxygen saturation levels may indicate an impending adverse event. Until now, it was not practical to monitor patients for repetitive reductions in airflow.

Most current pulse oximeters supply a real-time snapshot of a patient's oxygen saturation (SpO2) but cannot provide the added benefit of detecting patterns of desaturation that could be a useful indicator of evolving ventilatory compromise. With a high degree of sensitivity and specificity, the OxiMax SPD alert utilizes a complex algorithm to detect patterns of desaturation that are indicative of repetitive reductions in airflow.

"Increasing demands on healthcare provides an opportunity for technology, such as the OxiMax SPD alert, to offer greater efficiency, identify potential health complications and prevent potentially life-threatening events," said Chris Lowery, General Manager and Vice President, Patient Monitoring, Covidien. "Covidien is committed to advancing its respiratory monitoring systems globally to improve patient safety, medical efficacy and healthcare efficiency, today and in the future."

About Covidien

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 four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

1 "Opioids and Code Blue Emergencies," K. Fecho, L. Joyner and D. Pfeiffer, Anesthesiology 2008, 109 A34.

Source
Covidien

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