Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next-generation system is designed to provide high-velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. hospital beds don’t have wall air. When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting. The Company is planning a limited commercial release of HVT 2.0 in the United States in the fourth quarter of 2021.
“Clearance of HVT 2.0 enables us to provide high-velocity therapy to Patients throughout the hospital, which is very important when ICU beds become scarce. It will allow hospitals to leverage their general care floors and potentially reduce emergency room crowding and wait times. We will also use this next-generation platform, combined with the Vapotherm Access digital remote Patient monitoring platform, to begin learning how to treat complex lung disease Patients in the home,” said Joe Army, President and CEO of Vapotherm.