What are the treatment options for GERD?

Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder worldwide. Proton pump inhibitor (PPI) therapy is first line medical care of GERD. A significant proportion of patients become dependent on PPI therapy for symptom control. Long term use of PPI therapy can be associated with various side effects such as osteoporosis, vitamin B12 deficiency, small intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be reluctant to take PPIs for long duration and some are reluctant for surgery due to risk- complication associated with it. There is a large unmet need for patients suffering GERD.

The GERDX-System (endoscopic device) bridges the big treatment gap between medication and more invasive surgical treatment by being less invasive endoscopic therapy.

What is GERD-X?

The GERDX procedure, also known as ‘Endoscopic Plication’, is a minimally invasive procedure used in the treatment of GERD. The procedure is performed endoscopically through the mouth under general anaesthesia, stapling gastric folds around esophago-gastric junction to prevent gastric acid from escaping into the esophagus.

• When patients suffer from chronic gastroesophageal reflux disease (GERD) that is not well controlled with medications, or where long-term medications are not an option, the procedure of an endoscopic full-thickness plication (eFTP) performed with the GERDX-System could be an alternative.
• The GERDX-Procedure is a minimally invasive treatment for patients with gastroesophageal reflux disease (GERD) and a hiatal hernia up to 3cm.

WHY GERDX?

• minimally-invasive
• short intervention time (avg. 20min)
• IP address
• short hospitalization, fast recovery
• alternative treatment options remain for future

GERDX Treatment Procedure

The GERDX procedure, which attains similar results to those of well-known surgical procedures, has the major benefits of being less invasive with significantly lesser side effects. Additionally, the procedure does not stop or limit other treatment options if required in the future.

• STEP 1: In the first step, the applicator is gently placed into the stomach via the mouth and esophagus using an endoscope and a guidewire. The front half of the applicator is fully retroflexed, whereby the arms are opened, and the Tissue Retractor introduced into the tissue.
• STEP 2: The Tissue Retractor is then placed deep inside the gastric cardia mucosa (area of mucosa located distal to the gastroesophageal junction). The gastric wall is then withdrawn into the applicator’s open arms by pulling the mechanism back. Since the entire procedure is done endoscopically, whereby there is a light and camera attached on the endoscope, which can move without the retractor, the doctor is able to see the entire procedure on a monitor.
• STEP 3: The applicator’s arms are then closed, which results in a full-thickness duplication (eFTP, endoscopic full-thickness duplication) of the stomach wall. All the layers of the stomach wall in the target area are sutured through, a process that creates the foundation for long-lasting results of the GERDX procedure.
• STEP 4: After suturing the Tissue Retractor is removed, and the applicator’s arms are re-opened to release the tissue. The full-thickness duplication and tight closure of the gastro-esophageal connection around the shaft of the applicator are also ensured, after which the arms are closed again, and the applicator straightened, and removed from inside the patient’s stomach.

Possible adverse events of GERD-X Procedure

1. Return of the heartburn
2. Bloating discomfort
3. Chest pain
4. Excess gas
5. Problems while swallowing
6. The esophagus moving so that the stomach no longer supports the valve