eVent Medical recently said it received FDA 510(k) clearance for its Heliox gas delivery system for use with its Inspiration ventilator system.
The company says there have been a number of peer-reviewed medical publications demonstrating the utility of eVent’s Heliox delivery system on the Inspiration ventilator. Company officials said researchers found the Inspiration ventilator greatly reduces the consumption of Heliox when compared to other currently marketed, older ventilator designs. The Inspiration does not have a bleed system that can waste large amounts of the gas before it is delivered to the patient.
Heliox administration has been available on the Inspiration ventilator outside the U.S. since 2006. eVent Medical will begin marketing the Inspiration throughout the U.S. with a focus on the pediatric areas that have the highest need for Heliox with asthmatic patients.
February 2008