Covidien plc (COV) Wins FDA Nod For The Puritan Bennett 980 Ventilator
2/27/2014 6:59:39 AM
Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for the Puritan Bennett™ 980 Ventilator
DUBLIN, Ireland--(BUSINESS WIRE)--Covidien plc (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced its Puritan Bennett™ 980 ventilator has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
The new acute care ventilator from Covidien—designed to be simple, safe and smart—helps enable patients to breathe more naturally† through some of the most innovative breath technology available.
The most critical goal of clinicians is to get patients off mechanical ventilation as soon as possible. The Puritan Bennett 980 ventilator can help with a range of software capabilities, including Proportional Assist™* Ventilation Plus (PAV™*+) and Leak Sync software. Proportional Assist™* Ventilation Plus (PAV™*+) has been shown to help reduce asynchrony, 1-3 which studies have shown may reduce days on mechanical ventilation.4-6
“We believe mechanical ventilation should be natural enough to enable patients to breathe on their own more quickly,” said James E. Willett, vice president and general manager, Respiratory Solutions, Covidien. “The Puritan Bennett 980 ventilator provides clinicians with a simple, safe and smart way to care for patients.”
Patients on mechanical ventilation are often sedated to ease agitation and help them tolerate breath support and other medical interventions.7 The Puritan Bennett 980 ventilator features advanced synchrony tools that help clinicians set the ventilator to adapt to their patients’ unique needs and help provide the appropriate level of support throughout the breath.
The Puritan Bennett 980 ventilator system is for patients ranging from neonatal to adult. The ventilator system was also approved for commercial distribution in Japan and Canada and will be available in those countries and the U.S. in the coming months.
For more information about the Puritan Bennett 980 ventilator, please visit www.covidien.com/PB980.
†Compared to conventional mechanical ventilation
* Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license.
1. Xirouchaki N, Kondili E, Vaporidi K, et al. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008;34(11):2026-2034.
2. Xirouchaki N, Kondili E, Klimathianaki M, Georgopoulos D. Is proportional-assist ventilation with load-adjustable gain factors a user-friendly mode? Intensive Care Med. 2009;35(9):1599-1603.
3. Costa R, Spinazzola G, Cipriani F, et al. A physiologic comparison of proportional assist ventilation with load-adjustable gain factors (PAV+) versus pressure support ventilation (PSV). Intensive Care Med. 2011;37(9):1494-1500.
4. Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006;32(10):1515-1522.
5. de Wit M, Miller KB, Green DA, Ostman HE, Gennings C, Epstein SK: Ineffective triggering predicts increased duration of mechanical ventilation. Crit Care Med. 2009;37(10):2740-2745.
6. Epstein SK. Optimizing patient-ventilator synchrony. Semin Respir Crit Care Med. 2001;22(2):137-152.
7. Siegel MD. Management of agitation in the intensive care unit. Clin Chest Med. 2003;24(4):713-725.
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 develops, manufactures and sells a diverse range of industry-leading medical device and supply products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000 employees worldwide in more than 70 countries, and its products are sold in over 150 countries. Please visit www.covidien.com to learn more about our business.
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