The neurostimulation device may help to accelerate the removal of a patient’s breathing tube by restoring neurological swallowing control.
The FDA has granted breakthrough device designation (BDD) to the Phagenyx System, a neurostimulation device that aims to accelerate the removal of breathing tubes through neurogenic dysphagia treatment.
Dysphagia is a common adverse effect in tracheotomized patients and can block decannulation. Dysphagia also contributes to aspiration pneumonia and death, and may prolong hospital stays.
"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,” Reinhard Krickl, CEO of Phagenesis, said in a statement. “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."
The device, which delivers small amounts of electrical stimulation to the pharynx via a dual function catheter, enables improved swallowing function. Notably, the catheter can also be used to deliver enteral nutrition, fluids, and medication, if necessary.
Results from the PHAST-TRAC study of the Phagenyx system showed tracheotomized patients who received stimulation were 5 times more likely to be safely decannulated than controls.2
The randomized, single-blind, pivotal, superiority trial examined pharyngeal electrical stimulation for early decannulation in patients with stroke who were tracheotomized and had dysphagia. Ultimately, 69 patients were randomly assigned to receive active stimulation (n = 35) or sham (n = 34). Following the treatment period, 49% of patients in the active stimulation group were ready for decannulation compared with 9% in the sham group.2
"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 US patients also," Greg Behar, CEO of Nestle Health Science, said in a statement.
Phagenyx is currently not available for sales in the United States but is CE marked in Europe.
1. Phagenesis receives FDA breakthrough device designation for its Phagenyx System to accelerate removal of the breathing tube by treating neurogenic dysphagia [news release]. Manchester, England. Phagenesis. January 14, 2020. prnewswire.com/news-releases/phagenesis-receives-fda-breakthrough-device-designation-for-its-phagenyx-system-to-accelerate-removal-of-the-breathing-tube-by-treating-neurogenic-dysphagia-30098486html. Accessed January 14, 2020.
2. Dziewas R, Stellato R, van der Tweel I, et al. Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial. Lancet Neurol. 2018;17(10): 849-859. doi: 10.1016/S1474-4422(18)30255-