Overview

 

An Effective Solution for Chronic Acid Reflux

  EsophyX is revolutionizing the treatment of moderate to severe GERD through the TIF procedure. EsophyX surgical device

Corrects the anatomic cause of GERD

TIF (Transoral Incisionless Fundoplication) with the EsophyX device is the first procedure that provides an incisionless solution for correcting the root cause of GERD, an anatomic defect at the gastroesophageal junction. Inserted through the patient's mouth, under visual guidance of an endoscope, the EsophyX device is used to reconstruct a durable antireflux valve and tighten the LES (Lower Esophageal Sphincter), reestablishing a barrier to reflux and restoring the competency of the gastroesophageal junction. The result is the effective elimination of GERD. Recent clinical studies show that at two years following the procedure, 85% of patients are still heartburn free and 79% are still off daily PPIs.

Since TIF is non-invasive and repeatable, it offers the best of both worlds – the high effectiveness of a surgical repair and the low complication rate of a transoral approach.

  • Repairs the antireflux barrier
  • Reduces hiatal hernia ≤ 2 cm
  • Restores the angle of His
  • Creates a 3-5 cm long antireflux valve with 270˚ circumference, similar to the Nissen, Toupet, Hill, or Belsey procedures
  • Leaves future options open

Based on well-established principles of conventional GERD surgery

While based on many years of well-established surgical fundoplication concepts and techniques for the successful treatment of GERD, TIF is a more patient friendly yet effective treatment. It also allows surgeons to offer patients a surgical solution to their reflux without the risk of dysphagia, gas bloat and the other side effects and complications that can occur with more invasive procedures like the laparoscopic Nissen procedure.

An effective alternative to lifelong drug therapy

GERD is a disease that today is typically treated with proton pump inhibitors (PPIs). Pharmaceutical therapies like PPIs can lose their effectiveness over time, requiring progressively higher dosing. Research shows that of the approximately 30 million Americans diagnosed with chronic GERD and dependent on daily medications, 20-40% are not satisfied with PPIs. In addition, known side effects of long-term use of PPIs include osteomalacia (inadequate absorption of calcium and other minerals into the bones). Recent case studies on the adverse effects of long-term PPI use indicate a significantly higher incidence of hip fractures, particularly among women.

Key benefits of the TIF procedure:

  • 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
  • Clinical results are comparable to more invasive GERD surgical treatments like the Nissen procedure but with fewer side effects
  • Allows for earlier intervention
  • Improves quality of life score by 64% over PPIs
  • Reduces hiatal hernia in 89% of patients
  • Safe and atraumatic
  • Customizable to patient's needs and can be revised if required
  • Minimizes patient downtime. Most patient can return to work and normal activities in as little as one day

EsophyX is FDA cleared, CE marked and available in the U.S. and other parts of the world.

NP01951-01C