EsophyX
EsophyX™ is FDA cleared and CE marked, and available in the USA and the European Union.
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| (Transoral Incisionless Fundoplication) |
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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.
Features:
EsophyX™ Transoral Incisionless Fundoplication emulates the principles of the laparoscopic fundoplication but without incisions and with an added benefit of versatility.
Clinical Steps:
How to Order:
EsophyX™ is currently available in the following countries:
- Austria
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Belgium
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Denmark
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France
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Germany
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Greece
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Ireland
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Italy
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Luxembourg
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Mexico
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Netherlands
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South Africa
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Spain
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Portugal
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UK
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United States
To order this device (where available) or to request information please click the icon below.
PN C00659-01 Rev A
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