Published Study Supports Two-Year Safety and Efficacy Of Incisionless TIF Surgery for the Treatment of GERD
Redwood City, CA (March 26, 2009) — EndoGastric Solutions (EGS), the recognized
leader in the emerging field of Natural Orifice Surgery (NOS), today announced
publication of a two-year study of TIF (Transoral Incisionless Fundoplication)
procedure for the surgical treatment of GERD (gastroesophageal reflux disease)
confirming the procedure’s safety and efficacy. The study, conducted at Centre
Hospitalier Universitaire St. Pierre, Brussels, Belgium, by Professor
Guy-Bernard Cadiére, was published in the March 14, 2009 edition of Surgical
Endoscopy.
The results from the study showed stability of the TIF-created valve and
resultant long-term improvement in the patients’ symptoms. At two years after
TIF1 (first generation TIF technique) patients reported having experienced
cessation of heartburn, elimination of daily pharmaceutical therapy (proton pump
inhibitors) and improved quality of life superior to pharmaceutical therapy. Key
trial results include:
• 93% of patients reported a cessation of heartburn
• 71% of patients were completely off daily PPIs
• 64% of patients had a ≥ 50% improvement in GERD HRQL (health related
quality of life) scores compared with baseline on their PPIs
• 79% of patients experienced a complete cure or remission of their GERD
• 86% of patients were satisfied with TIF
• At 2 years no adverse events related to TIF were reported
“Surgeons and patients having been waiting for an effective and low-risk
surgical remedy for GERD without the complications associated with the Lap
Nissen,” explained Pr. Cadiére. “Although limited by the small study population,
this study substantiates that the TIF procedure is safe and effective long-term,
with no long-term complications, and results that are similar to the results of
a large multi-center, 86 patient study awaiting publication. The fact that
clinical effects are sustained from one to two years verifies that TIF achieves
serosa-to-serosa fusion, resulting in a robust and durable antireflux valve.
Additionally, in the two years since we started the study, the procedure has
continued to evolve and improve. We are now performing a third-generation TIF2
procedure with the second-generation EsophyX2 device, which results in a tighter
wrap and better efficacy.”
“EGS is continuing to build a foundation of research and clinical data to
support long-term safety and efficacy of TIF,” said Thierry Thaure, Chief
Executive Officer of EndoGastric Solutions. “Over 1200 TIF procedures have been
performed worldwide to date with no long-term complications. TIF delivers the
efficacy of partial fundoplication such as Toupet or Belsey procedures without
the associated long-term complications of a Lap Nissen.”
About GERD
Over 21 million Americans suffer from GERD. Typical symptoms include painful
heartburn, chronic cough, regurgitation, sleep disorders, asthma, and sore
throat, which occur when stomach acids break through a dysfunctional one way
valve and backwash up into the esophagus or are inhaled. The standard of care,
acid suppressive pharmaceutical therapies with PPIs (proton pump inhibitors),
can be effective at masking the condition and eliminating symptomatic heartburn
for some patients. However, new studies linking long-term use of PPIs to hip
fractures, the adverse interaction of PPIs with Plavix, and other adverse
conditions have some patients and their physicians rethinking their treatment
strategy. In addition, for a large patient population, persistent breakthrough
reflux, non-acid related symptoms of reflux, nighttime reflux (which disrupts
sleep), or even the promise of being shackled to a lifelong regimen of daily
drug therapy is motivation for them to seek a more permanent anatomical
correction for their GERD.
Although antireflux surgery has been shown to be more effective than PPIs in
long-term management of chronic GERD, patients are reluctant to undergo open or
laparoscopic surgery because of associated risks and side effects. Both the
laparoscopic antireflux surgery such as the Nissen procedure and the
incisionless TIF procedure reconstruct the deteriorated antireflux valve,
creating a robust physical barrier to reflux. The laparoscopic Nissen procedure,
while effective, is more invasive, involving as many as five small incisions and
substantial internal cutting and dissection. The Nissen procedure not only
requires considerable patient recovery but also has significant associated
risks, including dysphagia (difficulty swallowing) and gas bloat. The
incisionless TIF procedure with the EsophyX device was developed to create a
similar antireflux barrier as the Nissen procedure, but from within the body
with the device inserted through the mouth and without incisions or internal
dissection. Results are similar. Because TIF is incisionless, recovery and risk
of complications are reduced and patient satisfaction is generally higher.
About the TIF Procedure and the EsophyX Device
The TIF (Transoral Incisionless Fundoplication) surgical procedure corrects the
root cause of GERD, an anatomic defect at the gastroesophageal junction.
Inserted through the mouth, under visual guidance of an endoscope, the EsophyX
device is used to construct a robust antireflux valve, reestablishing a barrier
to reflux and restoring the competency of the gastroesophageal junction. The
result is the effective elimination of GERD.
About EndoGastric Solutions
EndoGastric Solutions (EGS) is a privately held corporation located in Redmond,
Washington and Redwood City, California. EGS is a pioneer in developing
incisionless transoral procedures for the treatment of upper gastrointestinal
conditions, including gastroesophageal reflux disease (GERD). EsophyX® is
cleared by the FDA, CE marked, and available for sale in the U.S. and other
parts of the world.
