FDA Grants Vapotherm’s De Novo Request for New Category for Precision Flow Hi-VNI System

The U.S. Food and Drug Administration (FDA) granted Vapotherm’s request for a new category (QAV), and expanded indications for the latest version Precision Flow, the Precision Flow Hi-VNITM system. The indication now states this system may be used to augment breathing of spontaneously breathing patients suffering from respiratory distress in the acute setting. This indication is very similar to pressure based non-invasive ventilation products. The Precision Flow Hi-VNI system is currently the only product listed under this new code. Read the full press release here.

The new category grant required the presentation of substantial clinical data showing that Hi-VNI® Technology relieves undifferentiated respiratory distress, including hypoxia and hypercapnia, in patients from neonates to adults. The clinical evidence demonstrated effectiveness in preventing mechanical ventilation as effectively as the gold standard of pressure based non-invasive ventilation, NiPPV.

Health care providers can now confidently select Vapotherm’s Hi-VNI Technology as an alternative to NiPPV to treat undifferentiated respiratory distress in hospital settings. Patients on Hi-VNI Technology are clinically proven to experience reduced work of breathing and improved gas exchange with the comfort and low risk of trading a tight-fitting mask for a comfortable nasal cannula interface. Patients can eat, drink, speak and take oral medication while receiving this mask-free form of non-invasive ventilatory support.

This new labeling also clarifies for clinicians the difference between Vapotherm’s Precision Flow Hi-VNI system and commodity humidifiers delivering high flow oxygen. These humidifiers are labeled only to add warmth and moisture to breathing gases to help patients tolerate higher flows of oxygen. In contrast, the Precision Flow Hi-VNI system delivers high flows at a high enough velocity to efficiently flush the upper airway in the limited time between breaths.

2018-10-16T15:23:45+00:00Oct 16|Vapotherm Blog|