Sommetrics Donates Airway Devices to COVID-19 Fight, Applies for Emergency Use Authorization
Sleep therapy maker Sommetrics Inc and its partially owned affiliate, aerFree LLC, are donating their aerFree product to select academic centers to assist in the management of COVID-19 respiratory impairment.
AerFree is a Food and Drug Administration (FDA)-cleared, single-use product intended to maintain the patency of the upper airway during medical procedures utilizing non-propofol sedatives. In parallel, an application was made to the FDA for Emergency Use Authorization to employ aerFree as an aid to intubation in patients with COVID-19. AerFree may expand the caliber of the upper airway, thereby facilitating first pass placement of endotracheal tubes and diminishing the infectious risk to healthcare personnel from prolonged intubations.
Kingman Strohl, MD, a pulmonologist and sleep specialist at Case Western Reserve University, says in a release, “This is a safe tool for critical care and anesthesia specialists to deploy in order to pull open the upper airway from the outside for a better view, reduce manipulations inside the airway, and improve procedure efficiency.”
Sommetrics also filed an Emergency Use Authorization request to use a modified aerSleep product to support patients with COVID-19 related respiratory impairment who are not candidates for mechanical ventilation. AerSleep, which is intended to treat obstructive sleep apnea using an integrated vacuum source, has been modified to utilize readily available sources of suction in the acute care setting. The modified aerSleep may be suitable for use over the course of days to weeks to reduce airway collapse in those with COVID-19 who have sleep apnea and/or are receiving sedative drugs. By expanding the upper airway, the modified aerSleep product may reduce the work of breathing. Since the modified aerSleep product is external to the airway, its use does not pose a risk of creating infectious aerosols, according to Sommetrics.
Both aerFree and the modified aerSleep product employ the Sommetrics aer+ technology, which involves the application of external negative pressure over the upper airway to comfortably and non-invasively hold the airway open. Aer+ is the basis of Sommetrics Inc and aerFree LLC products and numerous issued and filed patents. It has been shown to safely reduce airway collapse in those with all degrees of sleep apnea severity, and in patients developing apnea as the result of receiving sedative drugs in the acute care setting.
“We are grateful to be able to make what are believed to be significant contributions to the management of respiratory complications of COVID-19. We look forward to working with the medical community to facilitate adoption of our products into the best treatment practices for COVID-19 and airway collapse in a number of clinical settings,” says Richard Rose, MD, president, CEO, and chief medical officer of Sommetrics, in a release.
from Sleep Review https://www.sleepreviewmag.com/sleep-treatments/therapy-devices/sommetrics-donates-airway-devices-covid-19/