EndoStim has obtained the CE Mark for its implantable stimulator for treating gastroesophageal reflux disease (GERD). The device is implanted through a minimally invasive laparoscopy with electronic leads stretching to the lower esophageal sphincter. Electrical signals are delivered to the weakened muscle to help it keep the esophagus closed when not in use, but letting it open up when eating or belching.
The company touts the procedure’s lack of observed side effects, which it attributes to the fact that the surgery doesn’t actually alter any of the patient’s anatomy. The device has yet to receive regulatory approval in the U.S.
Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.
EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, “What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy.
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