Phagenesis announced today that it won breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control.
The Phagenyx System is a neurostimulation device designed to use pharyngeal electrical stimulation to treat the cause of dysphagia, accelerating the removal of the breathing tube in the process. Severe dysphagia with related insufficient airway protection is the primary reason that decannulation can’t be performed in tracheotomized patients weaned from mechanical ventilation, according to a news release.
Manchester, England-based Phagenesis said its Phast-Trac randomized controlled study revealed that tracheotomized patients treated with the Phagenyx System were five times more likely to be safely decannulated, compared to untreated control patients.
“Receiving breakthrough device designation is a key milestone, validating Phagenyx as a unique solution to accelerate decannulation that addresses a substantial unmet medical need currently causing negative consequences for risk of pneumonia,” Phagensis CEO Reinhard Krickl said in the news release. “This will lead to timely and successful rehabilitation, better patient comfort and positively impact on number of days in hospital, hospital readmissions and the financial cost of care.”
“Nestle Health Science has been working with Phagenesis for several years in Europe to build the clinical evidence for this treatment and we are excited that the breakthrough device designation will help to accelerate the process of making Phagenyx available to U.S. patients also,” added Nestlé Health Science CEO Greg Behar.
