UK-based Phagenesis Ltd has developed a new neurostimulation device to accelerate the removal of the breathing tubes through neurogenic dysphagia treatment.
The device which delivers small amounts of electrical stimulation to the pharynx (PES) via a dual function catheter enables improved swallowing function.
Apart from this, the catheter can also be used to distribute enteral nutrition, fluids, and medication, if necessary.
The FDA will offer Phagenesis with priority review and interactive communication during the Phagenyx De Novo review phase, as part of the breakthrough device programme.
The results from the PHAST-TRAC study of the Phagenyx system showed tracheotomized patients who received stimulation were five times more likely to be safely decannulated as compared to untreated control patients.
The US Food and Drug Administration has given the breakthrough designation for the device.
Dysphagia is considered as a common adverse effect in tracheotomised patients and can block decannulation. It may result in complications such as pneumonia, dehydration, aspiration, and may prolong hospital stays.