The StomaphyX™ is a pioneering device for Natural Orifice Surgery (NOS). Without incisions and with minimal patient downtime, StomaphyX can be used to create durable large tissue folds in the gastrointestinal tract. Performed under endoscopic visualization, StomaphyX™ is introduced into the body transorally (through the mouth). Once inside the stomach, the stomach wall is suctioned into the tissue port on the StomaphyX™ creating a large plication. Non-resorbable fasteners are then deployed across the fold to hold the tissue in place. Typically 10 to 20 folds are required depending on patient anatomy.
Stomaphyx
Indication:
The EndoGastric Solutions (EGS) EsophyX™ System with Serofuse™ Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
Benefits:
The EsophyX™ Transoral Incisionless Fundoplication (TIF) procedure is a novel surgical procedure for the treatment of reflux disease. The TIF procedure is based on the principles of surgical repair of the antireflux barrier and is intended to deliver similar benefits as the time-proven laparoscopic fundoplication.The TIF procedure reconstructs a robust antireflux barrier, thus restoring the gastroesophageal junction back to what is believed to be its natural anatomical geometry. TIF results in established parameters of antireflux surgery such as:
- Omega-shaped valve, 3-5 cm in length
- Restored angle of His
- Use of proprietary fastener technology that mirrors results of proven surgical suturing technique
- Reduction of hiatal hernia
- Serosa-to-serosa fusion
Approximately 14 million Americans experience symptoms of GERD, including heartburn and esophageal inflammation, on a daily basis. Most manage their disease with medications such as H2 blockers and proton pump inhibitors (PPIs). Since pharmacological therapy does not treat the underlying root causes of reflux, the deteriorated anatomy of the antireflux barrier, life-long medication therapy is required. Although surgery is highly effective, it is also very invasive, despite the laparoscopic surgical approach. For this reason, less than 1% of the patients choose surgical therapy to repair the anatomical defect(s) that cause GERD.
Stomaphyx
