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|Covidien Receives FDA 510(k) Clearance for Puritan Bennett(TM) 840 Ventilator to Extend Minimum Delivered Tidal Volume, Enabling Care of Neonatal Patients|
BOULDER, Colo., May 06, 2010 (BUSINESS WIRE) --Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Puritan Bennett(TM) 840 ventilator's minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.
The Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond withthe most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.
The ability to deliver a minimum tidal volume of 2mL will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator. This feature will complement recent enhancements to the Puritan Bennett(TM) 840 NeoMode(TM) software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.
"This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults," said Douglas Hansell, M.D., M.P.H., Chief Medical Officer and Vice President, Respiratory and Monitoring Solutions, Covidien. "Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator."
"At Covidien, we provide products and technologies designed to enable healthcare institutions to achieve both clinical excellence and healthcare economics goals," said James E. Willett, Vice President and General Manager, Respiratory and Monitoring Solutions, Covidien. "The Puritan Bennett 840 ventilator safely and reliably serves the needs of patients of various ages and sizes while delivering enhanced patient safety, medical efficacy and healthcare efficiency."
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 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.