Covidien receives FDA 510(k) clearance for Puritan Bennett 980 ventilator

27 February 2014 (Last Updated February 27th, 2014 01:00)

Covidien has obtained US Food and Drug Administration (FDA) 510(k) clearance for its Puritan Bennett 980 ventilator, the new acute care ventilator that delivers advanced breath technology for patients comfort and ease-of-use for clinicians.

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Covidien has obtained US Food and Drug Administration (FDA) 510(k) clearance for its Puritan Bennett 980 ventilator, the new acute care ventilator that delivers advanced breath technology for patients comfort and ease-of-use for clinicians.

By using new advanced synchrony tools, the Puritan Bennett 980 ventilator helps clinicians set the ventilator to adapt to their patients' unique needs and provide the appropriate level of support throughout the breath.

The Puritan Bennett 980 ventilator system is designed for patients ranging from neonatal to adult.

It offers a range of software capabilities, including proportional assist ventilation plus (PAV) and leak sync software.

PAV software for the Puritan Bennett 980 ventilator is a breath type that better manages work of breathing in spontaneously breathing patients and promotes natural breathing compared with conventional mechanical ventilation.

According to the company, this software has been shown to help reduce asynchrony, which studies have shown may reduce days on mechanical ventilation.

With its range of software capabilities, the new ventilator system helps clinicians to get patients off mechanical ventilation as soon as possible.

Covidien respiratory solutions vice-president and general manager James E Willett said: "The Puritan Bennett 980 ventilator provides clinicians with a simple, safe and smart way to care for patients."

The company expects to launch the ventilator system in Japan and Canada, where it was earlier approved for commercial distribution, along with the US in the coming months.

According to GlobalData estimates, the US ventilators market was valued at $163.9m in 2012 and is expected to grow at a CAGR of 3.4% to reach $206.4m by 2019.


Image: Puritan Bennett 980 ventilator gets FDA clearance. Photo: courtesy of Covidien/Business Wire.