Vapotherm, a privately held manufacturer of respiratory care devices for hospital and home use, announced today that it has received approval from the Medical Device Bureau of Health Canada for the Precision Flow® Heliox device which will be launched later this year in the Canadian hospital market. The device is part of Vapotherm's High Flow Specialty Gas Program.
"We are pleased to receive our license in Canada for Precision Flow® Heliox, the first high flow device specifically designed for heliox delivery, said Bill Niland, Chairman and Director of New Business Development at Vapotherm." The Company has also submitted for 510(k) clearance of the device in the U.S. and is also submitting for CE marking for other international markets.
Vapotherm's High Flow Specialty Gas Program was created to expand High Flow Therapy (HFT) beyond air and oxygen to other medical and specialty gases. The Company's flagship platform device, the Precision Flow®, was developed with a modular design concept to allow for several specialty applications in neonatal, pediatric and adult patient populations. In all applications, the device optimizes the delivery of gases via precise blending, flow control and temperature management. As with all Vapotherm HFT products, the overall goal is non-invasive respiratory support via a simple nasal cannula in a device that is easy for clinicians to operate but comprehensive in terms of safety and performance features. The Company plans to announce additional modules in the coming weeks.
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