Breakthrough device designation to dysphagia deviceMarch 6, 2020
Phagenesis Ltd has received Breakthrough Device Designation from the US FDA for its Phagenyx System.
The Phagenyx System is a novel neurostimulation device that helps to restore neurological swallowing control through Pharyngeal Electrical Stimulation.
The Phagenyx System treats the cause of dysphagia. In tracheotomised patients weaned from mechanical ventilation, severe dysphagia with related insufficient airway protection is the primary reason why decannulation cannot be performed.
The PHAST-TRAC1 randomised controlled study, published in Lancet Neurology in 2018, demonstrated that tracheotomised patients treated with the Phagenyx System were 5 times more likely to be safely decannulated when compared with untreated control patients.
Phagenyx is an innovative product using pharyngeal electrical stimulation (PES) to deliver a patient optimised train of electrical stimuli to oropharynx. The treatment restores safe swallowing by inducing and accelerating the re-organisation of the parts of the brain responsible for swallow coordination and control.