Vapotherm, a provider of High Flow Therapy (HFT) respiratory devices, has received the Food and Drug Administration (FDA) 510(k) clearance for its CE marked Flowrest homecare device.
The Flowrest delivers warmed, humidified high-flow breathing gases to patients via nasal cannula.
Utilizing patent pending humidification and breathing circuit technology, the device is designed to maximize ease of use and patient comfort, both of which are critical in homecare and other low acuity settings.
Vapotherm CEO Robert Storey said they are excited to expand leadership position in HFT with the launch of this device intended specifically for homecare use.
"We are pleased to answer the required patients need with Flowrest, which will address the broad population of patients who benefit from heated and humidified high flow breathing gases," Storey said.
High Flow Therapy via nasal cannula is utilized in hospitals throughout the world to provide respiratory support for spontaneously breathing adult, pediatric and neonatal patients with a variety of acute or chronic conditions.
Vapotherm said the clinical practice and research has demonstrated that its use can help clinicians avoid more invasive respiratory therapies.
Vapotherm’s gas conditioning technology allows for high flows to be delivered via a simple nasal cannula, allowing patients to avoid the discomfort and confinement of mask therapy.