FDA Approves New Aid For Stroke Survivors
The U.S. Food and Drug Administration (FDA) gave the green light to a new device that could aid stroke survivors. This device, the Phagenyx System, is designed to help patients with stroke-related dysphagia.
Dysphagia is a health condition characterized by difficulty swallowing. People with dysphagia may have to take more time or expend more effort in order to move food or liquids from their mouth to their stomach. Dysphagia can be painful, and it can make swallowing difficult or impossible. Other symptoms of dysphagia include:
- Coughing or gagging when swallowing
- Food or stomach acid backing up into the throat
- Frequent heartburn
- A sensation of food being stuck in the throat, chest, or behind the sternum
- Weight loss
Dysphagia is common after a stroke. Strokes occur when blood flow to the brain is blocked for some period of time. During a stroke, the part of the brain that is not receiving blood can shrivel or die. Strokes can cause people to lose fine motor skills such as chewing due to the death of brain tissue.
According to the DeNovo Database entry, the Phagenyx system is a type of device called an Oropharyngeal Electrical Stimulator (OES). An OES is a device that affects the nerve fibers in the oropharynx, a part of the throat in the back of the mouth. When a controlled electrical charge is delivered to these nerves, it can aid the patients in swallowing by stimulating muscle contraction to move the food or liquid down the esophagus.
The Phagenyx system is manufactured by Phagenesis Limited, a medical device manufacturer based in the United Kingdom. The device consists of hardware with electronics for generating an electrical current as well as software for monitoring treatment and storing patient data. The FDA marketing approval certifies this device as safe to use in human subjects and allows doctors to begin incorporating it into their treatment regimen for stroke survivors.