Vapotherm’s Precision Flow Hi-VNI system is now approved to augment breathing of spontaneously breathing patients suffering from respiratory distress in a hospital setting, according to an expanded FDA indication. The approval makes the Precision Flow Hi-VNI system a viable alternative to noninvasive positive pressure ventilation (NIPPV) for most patients, according to Vapotherm.
In addition, the FDA has granted the device a new product category and product code (QAV), making it the only product in the QAV category. Vapotherm anticipates that this version of the Precision Flow will be widely available worldwide by January 2019.
The expanded indication was based on clinical evidence that Hi-VNI Technology, which is incorporated in all of Vapotherm’s Precision Flow products, is non-inferior to NiPPV in preventing mechanical ventilation, according to the company.
Hi-VNI Technology flushes the carbon dioxide heavy and oxygen depleted exhaled air from the respiratory dead space in the upper airway between breaths and replaces it with optimally humidified oxygen rich breathing gas delivered through a nasal cannula. As a result, it provides noninvasive ventilatory support and reduces the work of breathing. Patient’s symptoms are relieved, and with no mask, they are able to eat, drink, speak, participate in their care, and avoid mask-related risks of claustrophobia, aspiration and pressure ulcers.
Vapotherm, Inc. is a privately held developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Over 1.5 million patients have been treated with Vapotherm Hi-VNI Technology. For more information, visit www.vapotherm.com.
Hi-VNI® Technology allows for the fast, safe treatment of undifferentiated respiratory distress with one simple tool. Hi-VNI Technology has a simple nasal cannula that delivers warm, humidified air without sealing to the face, making it comfortable for patients and reducing the risks and care complexities associated with mask therapies. While being treated, patients can talk, eat, drink and take medication. Hi-VNI Technology is a front-line tool for respiratory distress—including hypoxia, hypercapnia and dyspnea.