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American Stroke Association Guidelines Include Pharyngeal Electrical Stimulation for Post-Stroke Dysphagia

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ASA Recognizes Pharyngeal Electrical Stimulation for Post-Stroke Dysphagia

The American Stroke Association (ASA), an offshoot of the American Heart Association (AHA), has formally recognized pharyngeal electrical stimulation (PES) as a treatment for post-stroke dysphagia (difficulty swallowing).

This inclusion marks the first time PES has been integrated into the AHA/ASA's stroke treatment guidelines, signaling a significant advancement in managing a common and debilitating post-stroke complication.

Guideline Details and Recommendations

The 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke, published on January 26, specifically recommends PES as a beneficial treatment. Its primary aims are to reduce dysphagia severity and lower the risk of aspiration in stroke patients.

For patients with severe stroke experiencing dysphagia, who require tracheotomy and mechanical ventilation, the revised guidelines indicate that PES treatment after ventilator weaning can significantly decrease the severity of dysphagia, lower aspiration risk, and expedite decannulation.

Phagenesis' Phagenyx System

Phagenesis, a UK-based company, is the manufacturer of the Phagenyx PES system. This innovative system targets the neurological components involved in swallowing coordination to help restore function post-stroke. It operates by delivering low electrical currents to throat nerves via a catheter inserted through the nose.

The Phagenyx system has achieved several key regulatory milestones:

  • De novo clearance from the US Food and Drug Administration (FDA) in October 2022.
  • European CE mark obtained in 2012.
  • Approval under the European Union’s Medical Device Regulation (EU MDR) in August 2024.

Currently, Phagenyx is reported to be the only commercialized PES treatment available to patients in the US and EU. In March 2024, Phagenesis secured $42 million in Series D financing to support its commercialization efforts in the US and expand its market presence in Europe.

Impact on Stroke Care

Dysphagia affects an estimated 46.6% of stroke patients, posing a substantial challenge to recovery. Traditional treatment primarily involves monitoring, rehabilitative therapy, and dietary adjustments. Despite these efforts, up to 50% of individuals may still experience dysphagia six months after a stroke, which can significantly elevate the risk of pneumonia and death.

Dr. Alex Choi, a professor of neurosurgery and neurology at the University of Texas Health Science Center at Houston, commented on the historical landscape of dysphagia treatment.

"Despite the prevalence and impact of dysphagia, there have historically been few significant therapeutic interventions to improve patient outcomes," Dr. Choi stated. He added that the inclusion of PES in the guidelines indicates the availability of a validated therapeutic option for routine stroke care.

Broader Market Context

The neuromodulation devices market is experiencing rapid advancement, with this treatment modality also being applied in addressing other conditions such as incontinence, migraine, and depression.

According to analysis by GlobalData, the global neuromodulation devices market is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.7%, reaching a valuation of $12.9 billion in 2034, up from $6.35 billion in 2024.