For Surgeons
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Frontline surgical management of GERD
TIF (Transoral Incisionless Fundoplication) with EsophyX is an innovative, clinically-proven and incisionless surgical approach to treating gastroesophageal reflux disease (GERD). The procedure reconstructs a robust antireflux barrier at the gastroesophageal junction to restore it to what is believed to be its natural anatomical geometry.The procedure is based on the well-established principles of conventional GERD surgery like laparoscopic Nissen fundoplication, but it is less invasive, more versatile, and free of the chronic complications (e.g., chronic dysphagia and gas bloat syndrome) commonly associated with conventional procedures. This eases the obstacles in the patient's decision to pursue GERD surgery and also allows for earlier intervention of the disease.
TIF also mirrors the outcomes achieved by conventional GERD procedures. There is considerable long-term clinical data showing that conventional procedures achieve effective control of reflux.1 Recent clinical studies of TIF show that 85% of patients are still heartburn free and 79% are still off daily PPIs at two years.2
For the first time, TIF enables surgeons to operate transorally under endoscopic guidance to create a tight, durable GE (gastroesophageal) valve while adhering to all the basic principles of conventional GERD surgery.
- Wrap a portion of the fundus around the distal esophagus
- Restore/lengthen intra-abdominal esophageal length
- Recreate the angle of His
- Augment high-pressure zone of esophagus
- Reduce hiatal hernia ≤ 2 cm
Procedure overview
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The TIF procedure is an innovative form of natural orifice surgery (NOS) that provides a step forward in the evolution of the treatment of GERD. The EsophyX surgical device is introduced into the patient’s body through the mouth 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 achieves:
- 270˚ valve, 3-5 cm in length
- Restoration of the angle of His
- Reduction of hiatal hernia ≤ 2 cm
- Serosa-to-serosa fusion
- Use of proprietary fastener technology that mirrors results of proven surgical suturing technique
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Pre-TIF dysfunctional GE valve. |
Post-TIF reconstructed GE valve. |
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TIF is the first procedure that provides an incisionless solution to a disease that is typically treated with pharmaceutical therapy. However, GERD is a progressive disease and the pharmaceuticals often 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 therapy have the option of laparoscopic GERD surgery, which has long proven effective in treating the disease. But due to the invasive nature and associated side effects such as gas bloat and dysphagia of conventional procedures, fewer than 1% of GERD sufferers elect to have conventional surgery.
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How the TIF procedure is performed:
Recent published clinical results support long-term safety and efficacy of TIFA two-year study of TIF conducted at Centre Hospitalier Universitaire St. Pierre, Brussels, Belgium, by Professor Guy-Bernard Cadiére confirmed the procedure’s long-term safety and efficacy. The results of the study were published in the March 14, 2009 edition of Surgical Endoscopy, which showed stability of the TIF-created valve and resultant long-term improvement in the patients’ symptoms. At two years after TIF, patients reported having experienced cessation of heartburn, elimination of daily pharmaceutical therapy (PPIs), and improved quality of life superior to pharmaceutical therapy. Key trial results include:2
Benefits of the TIF procedure:
Compares favorably with other surgical treatments for GERDAs Nissen procedures continue to decrease and the market demands a less invasive solution, the TIF procedure provides a more patient-friendly solution.
What results should the patient expect from the TIF procedure?Results vary from patient to patient, but the experience to date indicates patient results similar to those provided by conventional antireflux surgical procedures. IndicationThe EsophyX device is FDA cleared for 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. SerosaFuse® Fasteners:
How do I arrange training or a meeting with my local EGS sales representative?Contact us to arrange an in-service meeting with your local EGS representative. |
1 Watson LW. Endoscopic Antireflux Surgery: Are We There Yet? World Journal of Surgery 2008 April 23.
2 Cadière GB, Van Sante N, Graves JE, Gawlicka AK, Rajan A. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication (TIF) using EsophyX. Surgical Endoscopy 2009; 23: 957-964.
3 Bell and Freeman Surgical Endoscopy Accepted for publication October 24, 2010.
4 Serosa-to-serosa plications and 2-year durability testing with SerosaFuse fasteners inserted with EsophyX device.
NP01931-01C