The US Food and Drug Administration (FDA) has granted Somnics clearance for its capability to change the negative pressure setting of its iNAP sleep therapy device.
According to a release from Somnics, the feature will enhance the success of obstructive sleep apnea (OSA) treatment and empower physicians to titrate the device using the user-friendly iNAP Lab+ App, available for iOS and Android devices.
“We are extremely proud to have received FDA clearance for the pressure titration capability of our iNAP sleep therapy device,” says Olivier Lauzeral, general manager of Somnics Health, the US branch of Somnics, in a release. “This innovation marks a significant milestone in PAP alternative treatments for all severities of obstructive sleep apnea, allowing physicians to provide tailored care to their patients. Our ultimate goal is to make OSA therapy more patient-friendly, comfortable, and effective. This titration capability, combined with the small form factor, excellent battery life, silence and comfort of iNAP, brings us closer to realizing that vision.”
Physicians have the ability to adjust the negative pressure settings of the iNAP sleep therapy device between -27 cmH2O and -122 cmH2O, ensuring optimal treatment efficacy and comfort.
The iNAP sleep therapy system, cleared by the FDA for all severities of OSA, utilizes negative pressure in the oral cavity delivered by its embedded suction pump to position the tongue and oral soft tissues forward and upward, enabling the opening and stabilization of the upper airway passage while allowing patients to breathe freely through their nose.
Previously, the iNAP sleep therapy device was dispensed with a fixed pressure setting at 53 cmH2O. While this pressure worked well for many patients, certain cases would benefit from different, sometimes deeper, pressure settings to maintain airway patency, according to a release from the company. Data on seal time are collected through the iNAP Lab+ App, with the information available to healthcare providers on a secure online portal. This interface enables physicians to make real-time adjustments, monitor patient progress, and provide personalized care from anywhere, at any time.
Somnics is actively collaborating with healthcare professionals and sleep clinics to integrate iNAP into their OSA treatment protocols as a first line of treatment.