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Medical Devices / Submissions and Approvals / Commercial Operations

Covidien Obtains Gets FDA Clearance for New Acute Care Ventilator

Feb. 28, 2014

Covidien plans to launch its Puritan Bennett 980 ventilator in the U.S. in coming months, following receipt of FDA 510(k) clearance, the company said Wednesday.

The acute care ventilator — capable of use with neonates to adults — features advanced synchrony tools, such as Proportional Assist Ventilation Plus (PAV) and Leak Sync software, that aid clinicians in adjusting the system to each patient’s unique needs, the company said. According to Covidien, PAV helps to reduce mismatches between the patient’s need for breath and the ventilator’s delivered breath, leading to fewer days on mechanical ventilation.

“We believe mechanical ventilation should be natural enough to enable patients to breathe on their own more quickly,” said James Willett, vice president and general manager of Covidien’s Respiratory Solutions unit. “The Puritan Bennett 980 ventilator provides clinicians with a simple, safe and smart way to care for patients.”

The Puritan Bennett 980 system is also approved in Canada and Japan and will be available in those countries in coming months as well, Covidien said. — Meg Bryant

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