B&B Medical Technologies has released the first FDA 510(k) cleared bubble continuous positive airway pressure (PAP) valve for use with infants weighing <10 kg, according to information from the company.
The design of the new Babi.Plus Bubble PAP Valve 0–10 cm H2O allows airway pressure to be easily set without the time-consuming tasks normally associated with bubble CPAP devices. Babi.Plus Bubble PAP Valve provides a safe, accurate, and convenient method for delivering CPAP therapy to premature infants to increase end lung pressure above atmospheric in constant flow conditions.
The patent-pending Babi.Plus Bubble PAP Valve is adjustable from 1 to 10 cm H2O with an accuracy of +/- 1 cm of H2O using gas flows from 1 to 12 liters per minute. A 360 degree swivel inlet accepts 15 mm OD and 22 mm ID circuit connectors for easy installation to the expiratory limb of the breathing circuit. A fluid level adjustment port allows water or acetic acid levels to be easily maintained without disconnecting the circuit or loss of PAP. The expiratory ports direct gas quietly away from clinicians.
“FDA clearance of the Babi.Plus Bubble PAP Valve now allows the proven therapy of Bubble CPAP for premature infants to be easily implemented with standardized protocols without hospital personnel having to design, build, and maintain their own critical care medical devices,” said Beth Keifer, vice president of sales and marketing for B&B Medical Technologies. “The Babi.Plus Bubble PAP Valve is clinician designed and tested, and fills a growing need for the treatment of critically ill neonatal infants.”