FDA Clears Covidien’s Puritan Bennett™ 980 Ventilator

Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.

Background

The most critical goal for clinicians is to get patients off mechanical ventilation as soon as possible. Covidien says the Puritan Bennett 980 ventilator can help in this regard 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, which studies have shown may reduce days on mechanical ventilation.

Patients on mechanical ventilation are often sedated to ease agitation and help them tolerate breath support and other medical interventions. 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.

Company comments

“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.”

* Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license.

Source: Covidien plc, Business Wire

 

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