Phagenesis today announced that the US Food and Drug Administration (FDA) has granted a de novo request for the Phagenyx neurostimulation system, which uses pharyngeal electrical stimulation (PES) to restore swallowing control in patients with severe dysphagia post stroke. The company is now preparing a targeted launch in the USA.
“Dysphagia affects millions of people worldwide and many do not receive the desired outcome with currently available treatments,” said Marta Kazandjian (Stony Brook Southampton Hospital, New York, USA). “Adding an innovative therapy like Phagenyx has the potential to accelerate results and may allow the patient to spend fewer days in the hospital, which would significantly improve quality of care and patient experience.”
The Phagenyx system treats neurogenic dysphagia using PES, targeting the neurological components of swallowing coordination. Phagenyx therapy has demonstrated best results when delivered at the earliest stages after injury to enhance neurorehabilitation and restore swallowing control, according to a Phagenesis press release.
“There is limited awareness of the significance of dysphagia in the critical care setting following prolonged mechanical ventilation or tracheostomy,” added Wade Smith (University of California San Francisco [UCSF], San Francisco, USA). “Such patients cannot manage their own saliva, creating a high risk for aspiration and their safety. Phagenyx has the potential to treat patients early in the ICU [intensive care unit], which has been shown to accelerate recovery, reduce hospital length of stay and prevent downstream complications.”
The Phagenyx system is designated as a Breakthrough Device by the US FDA, which—according to the release—reflects clear unmet needs in current dysphagia care. Phagenyx is commercially available in Europe and is supported by numerous randomised controlled trials and larger-scale real world registries too, the release adds.