Endostim has created a ground-breaking technology called the Endostim System, for the treatment of drug-resistant GERD. The new device was given Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
As a result of the device, medical device development, evaluation, and review are accelerated while maintaining statutory approval or clearance requirements, so patients and healthcare professionals have timely access to them for a more accurate diagnosis or treatment of life-threatening or irreversibly debilitating conditions or diseases.
The lower esophageal sphincter, the muscle ring that separates the oesophagus from the stomach, is affected by gastroesophageal reflux disease, also known as GERD (LES).
GERD (esophagus) occurs when stomach acid backflows into the tube linking the mouth and stomach. The esophageal lining may become irritated due to acid reflux. Most people suffer from acid reflux periodically, but GERD occurs if it persists for an extended period of time.
The symptoms of GERD might include pain, regurgitation, difficulty sleeping, chronic cough, vocal irritation, lung inflammation, abnormal cells, and an increased risk of cancer.
A short, minimally invasive laparoscopic technique is used to implant a neurostimulation device and lead as part of the EndoStim System. The lower esophageal sphincter (LES) muscle in the patient is automatically provided with modest electrical signals throughout the day as part of the system's long-term reflux management mechanism (the underlying cause of GERD).
With the use of an external portable controller and wireless programming by a doctor, the EndoStim system automatically stimulates the LES. This is so that it can operate regularly without the patient feeling anything.