Covidien receives FDA clearance for new ventilator leak compensation software

www.covidien.comAug 6 2009

Covidien has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Leak Compensation software feature for the Puritan Bennett 840 ventilator system. This option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting.

During either invasive or noninvasive ventilation, air leaks past a mask, nasal prongs, nasal pillow, supraglottic airway, endotracheal tube or tracheostomy tube can result in loss of gas volume, potentially causing subsequent dysynchrony between a patient's spontaneous breathing efforts and the ventilator's response.

The Leak Compensation software for the Puritan Bennett 840 ventilator automatically adjusts for leaks of up to:

• 10 liters per minute (lpm) for neonates with an ideal body weight as low as 0.5 kg
• 40 lpm for pediatric patients
• 65 lpm for adults

The Leak Compensation software also minimizes potential guesswork in determining the appropriate settings required to compensate for leakage.

"Gas leakage presents a challenge in high-leak environments, particularly during noninvasive ventilation where leaks associated with the use of masks, nasal prongs and nasal pillows frequently occur. These leaks can contribute to significant asynchrony between a patient and the ventilator, which in turn might impede weaning and increase the time that the patient is ventilator-dependent," said Roger S. Mecca, M.D., Vice President, Medical Affairs, Respiratory and Monitoring Solutions, Covidien. "Covidien now offers software that quickly adjusts for leakage, improving patient-ventilator synchrony and triggering. It is especially valuable for preventing auto-triggering when the leakage rate exceeds the flow-triggering threshold."

The Puritan Bennett 840 ventilator system with Leak Compensation software is available now and is intended for use in hospitals and similar medical care facilities. It may also be used during transport within such facilities if appropriate electrical power and compressed gas sources are available.

"This FDA 510(k) clearance allows Covidien to make respiratory therapists and nurses aware that new software for their Puritan Bennett 840 ventilator system is available for them to employ during care, ideally improving clinical outcomes," said Jim Willett, General Manager and Vice President, Airway and Ventilation, Respiratory and Monitoring Solutions, Covidien.