Endoluminal Fundoplication

Indication:

The EsophyX™ device is a sterile, single-use device for performing endoluminal fundoplication procedures (ELF) for tissue reconfiguration for the creation of gastroesophageal valves and reduction of hiatal hernias, in the treatment of gastroesophageal reflux disease.

Benefits:

The EsophyX™ Endoluminal Fundoplication (ELF) procedure is a novel endoluminal surgical procedure for the treatment of reflux disease. The ELF procedure is based on the principles of surgical repair of the gastroesophageal junction and is intended to deliver similar benefits as the time-proven laparoscopic fundoplication.
The ELF procedure reconstructs a robust anti-reflux barrier valve, thus restoring the gastroesophageal junction back to what is believed to be its natural anatomical geometry. ELF results in established parameters of antireflux surgery such as:

• Omega-shaped, 270 degree, 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.

Features:

EsophyX™ Endoluminal Fundoplication emulates the principles of the laparoscopic fundoplication but with no incisions and with an added benefit of versatility.