Covidien has received FDA 510(k) clearance for its Puritan Bennett 980 ventilator, according to a company announcement.
The PB 980 is an acute care ventilator is designed to help patients breathe more naturally, compared to conventional mechanical ventilation, and help clinicians get patients off mechanical ventilation as soon as possible, according to Covidien.
The device is designed for use with neonatal to adult patients.
“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.”
The PB 980 is equipped with a range of software capabilities, including Proportional Assist Ventilation Plus (PAV+) and Leak Sync software.
PAV+ has been shown to help reduce asynchrony, according to studies cited by the company. Reducing asynchrony may reduce days on mechanical ventilation, and the PB 980 ventilator features advanced synchrony tools to:
- Assist clinicians setting the ventilator to adapt to their patients’ unique needs;
- Help provide the appropriate level of support throughout the breath.
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.