Phagenesis’ Dysphagia Treatment Grabs FDA Breakthrough Device Status

The FDA granted Phagenesis breakthrough device designation for its Phagenyx system, a neurostimulator that uses electrical stimulation to help restore swallowing control.

The system treats the cause of dysphagia, which can occur in tracheotomized patients who have been weaned off mechanical ventilation.

Severe dysphagia with insufficient airway protection is the primary reason why patients cannot have a tracheostomy tube removed when they no longer need it.