PRODUCT: EsophyX / Surgeons
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An Effective Anatomical Treatment for Moderate to Severe GERD
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Indication:
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 (GERD) 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.
Procedure overview:
The revolutionary EsophyX TIF (Transoral Incisionless Fundoplication) procedure, an innovative form of “incisionless” transoral natural orifice surgery, or NOS for short, offers a giant leap in the evolution of the treatment of GERD. The EsophyX surgical device is introduced into the patient’s body through the mouth, not through an abdominal incision, and is used to correct the root cause of GERD, an anatomic deficiency at the gastroesophageal junction.
Under visual guidance of an endoscope, the TIF procedure reconstructs the antireflux barrier and restores the competency of the gastroesophageal junction, resulting in the effective elimination of GERD. 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
TIF is the first procedure that provides an incisionless anatomical solution to a disease that today is typically treated with acid antisecretory medications, either PPIs (proton pump inhibitors) or histamine receptor antagonists (H2 blockers). But GERD is a progressive disease, and the pharmaceuticals typically lose their effectiveness over time. GERD sufferers today are also concerned about the well-known adverse effects of long-term use of PPIs, including osteomalacia (inadequate absorption of calcium and other minerals into the bones, essential to bone health). 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. Add to all that such lifestyle changes as special daily diets and pill regimens and having to reduce or eliminate activities like playing sports.
Adults suffering from GERD who no longer respond adequately to pharmaceutical treatments have the option of GERD surgery, which has long proven very effective in treating the disease. But because the procedure is so invasive, despite the laparoscopic approach, fewer than 1% of GERD sufferers elect to have the procedure performed.
Though the EsophyX TIF procedure is closely based on the well-established principles of the Gold Standard form of conventional GERD surgery, it is truly “patient friendly” and typically is performed in about 30-50 minutes. There are no external incisions or internal dissection. Most patients go home the next day and return to normal activities within a few days.
Frontline Surgical Management of GERD
The TIF2 procedure with the EsophyX device is a unique surgical approach that mirrors the outcomes provided by more invasive surgical antireflux procedures but with fewer adverse effects.
- Repairs the antireflux barrier
- Reduces hiatal hernia < 2 cm
- Restores the angle of His
- Create a 3-5 cm long antireflux valve with ~280˚ circumference - similar to the Nissen, Toupet, Hill, or Belsey procedures
- Reduces or eliminates esophagitis
- Significantly improves patient quality of life (sleeping, late night eating, food choices, etc.)
- Leaves future options open
Compares Favorably With Other Surgical Treatments for GERD
As Nissen procedures continue to decrease and the market demands a minutely invasive solution, the EsophyX TIF procedure provides the perfect patient-friendly, low-risk solution.
How EsophyX Works:
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| Step 1: The specially designed EsophyX device enters the esophagus through the mouth and is positioned at the junction of the stomach and esophagus. |
Step 2: The EsophyX device pulls and fastens a tissue fold. |
Step 3: Step 2 is repeated multiple times to reconstruct a robust, tight valve that prevents the reflux of stomach contents up into the esophagus, resulting in the effective elimination of GERD. |
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Before EsophyX TIF Procedure
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12 Months After EsophyX TIF Procedure
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SerosaFuse® Fasteners:
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SerosaFuse fastener
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- Made of non-resorbable polypropylene, equivalent web strength to 3.0 suture
- Holds full-thickness serosa-to-serosa plications to enable serosal fusion
- H-shaped, open-ended fastener design, not likely to surround and trap nerves or blood vessels
- Larger than stylet - reduces the incidence of bleeding
- Non-resorbable, continues to hold
- Proof of concept — 2-year follow-up on SerosaFuse fasteners1
1Serosa to serosa plications and 2-year durability testing with SerosaFuse fasteners inserted with EsophyX device.
What results should the patient expect from the EsophyX procedure?
Results vary from patient to patient, but the experience to date indicates patient results similar to those provided by conventional antireflux surgical procedures.
Benefits of the EsophyX TIF procedure:
- Effective and patient-friendly
- Allows for effective, long-term solution to GERD
- Eliminates heartburn in over 85% of patients
- Gets 79% of patients off PPIs 2 years after the procedure
- No external incisions and no internal dissection minimizes patient discomfort and shortens recovery
- Allows for earlier intervention
- Improves quality of life score by 64% over PPIs
- Reduces hiatal hernia in 89% of patients
- Safe and atraumatic
- Flexible shaft for atraumatic insertion
- Stylet enclosed within shaft during insertion, procedure and withdrawal
- Incisionless transoral insertion reduces/eliminates risk of infections and incisional herniation
- Customizable to patient needs
- Delivers an unlimited number of fasteners with a single insertion to meet the needs of each individual anatomy
- Adjustable and/or revisable transorally to preserve future treatment options
- Minimizes patient downtime. Most patient can return to work in as little as one day
Other EsophyX Information:
Patient Brochure Downloads:
Surgeon Brochure Downloads:
How to Order:
Contact us for more information on the EsophyX distributor in your area.
EsophyX is FDA cleared and CE marked and available throughout the European Union, the U.S, and other parts of the world.
C01798-01 A
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