EXETER, N.H., Oct. 9, 2018 /PRNewswire/ — Vapotherm, Inc. (Vapotherm), a baton in avant-garde respiratory technology, today appear that the U.S. Food and Drug Administration (FDA) has accepted Vapotherm’s latest adaptation of the Precision Flow® product, the Precision Flow Hi-VNI™ system, a new artefact class and artefact cipher (QAV). The FDA additionally accepted an broadcast adumbration for the arrangement that states it may be acclimated to augment breath of spontaneously breath patients adversity from respiratory ache in a hospital setting. This accommodating citizenry is agnate to that advised by added forms of non-invasive ventilation, authoritative the Precision Flow Hi-VNI arrangement a applicable another to Non-invasive Positive Burden Blast (NiPPV) for best patients. The Vapotherm Precision Flow Hi-VNI arrangement is currently the alone artefact in the QAV category.
To accretion these broadcast claims, and aboriginal in class grant, Vapotherm submitted abundant analytic abstracts that Hi-VNI Technology can cautiously and finer be acclimated in the analysis of akin respiratory ache in patients, alignment from newborns to adults. The actual accepted of affliction for non-invasive administration of such patients has been NiPPV, a pressure-based anatomy of non-invasive ventilation. Vapotherm’s acquiescence included analytic affirmation that Hi-VNI Technology, which is congenital in all of Vapotherm’s Precision Flow products, is non-inferior to NiPPV in preventing automated ventilation. Automated blast essentially increases accident to the accommodating of infections, chase dependence, and mortality, as able-bodied as increases costs to the hospital, and is about acclimated alone back added approaches accept been exhausted. The analytic affirmation approved agnate capability to NiPPV in preventing automated blast in patients behindhand of the basal account of the respiratory distress, and whether the patient’s primary botheration was accepting abundant oxygen or accepting rid of abundant carbon dioxide.
“We are captivated with the admission of this new artefact cipher by the FDA. We accept it clarifies the adapted analytic use of Hi-VNI Technology and informs clinicians that it is safe to use as a apparatus to amusement akin respiratory distress,” said Dr. Michael McQueen, Vice President of Medical Education at Vapotherm. “It emphasizes that Hi-VNI Technology has a agnate analytic appliance of ventilatory abutment to the accepted of affliction of NiPPV, but after the tight-fitting mask.”
Clinicians accept apparent the appulse on their patients. “Many patients with respiratory ache accept adversity with the abounding face mask. They can become claustrophobic, authoritative the respiratory abortion worse,” said Aaron Boyd, MBA, M.D., Chief Medical Officer, Norman Regional Health System. “Vapotherm’s technology helps our clinicians cautiously and calmly amusement these patients abundant added calmly and beneath invasively.”
How It Works Hi-VNI Technology flushes the carbon dioxide abundant and oxygen depleted exhaled air from the respiratory asleep amplitude in the high airway amid breaths and replaces it with optimally humidified oxygen affluent breath gas delivered through a nasal cannula. As a result, it provides non-invasive ventilatory abutment and reduces the assignment of breathing. Patient’s affection are relieved, and with no mask, they are able to eat, drink, speak, participate in their care, and abstain mask-related risks of claustrophobia, aspiration and burden ulcers.
The Precision Flow Hi-VNI arrangement that has been accepted the new artefact class includes assertive updates to the centralized electronics to accede with the latest standards for medical accessory equipment. It additionally includes updates to software and instructions for use adapted to this accommodating population. Vapotherm anticipates that this adaptation of the Precision Flow will be broadly accessible all-embracing by January, 2019.
Vapotherm, Inc. is a a captivated developer and architect of avant-garde respiratory technology based in Exeter, New Hampshire, USA. The aggregation develops innovative, comfortable, non-invasive technologies for respiratory abutment of patients with abiding or astute breath disorders. Over 1.5 actor patients accept been advised with Vapotherm Hi-VNI Technology. For added information, visit www.vapotherm.com.
Hi-VNI® Technology allows for the fast, safe analysis of akin respiratory ache with one simple tool. Hi-VNI Technology has a simple nasal cannula that delivers warm, humidified air after sealing to the face, authoritative it adequate for patients and abbreviation the risks and affliction complexities associated with affectation therapies. While actuality treated, patients can talk, eat, alcohol and booty medication. Hi-VNI Technology is a front-line apparatus for respiratory distress—including hypoxia, hypercapnia and dyspnea.
View aboriginal content:https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-vapotherm-hi-vni-technology-system-a-new-product-category-300727888.html
SOURCE Vapotherm, Inc.
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