EndoGastric Solutions(TM)
announces successful completion of their Phase 1 study of EsophyX(TM) for
the treatment of gastroesophageal reflux disease (GERD). The ELF procedure
was offered as a new incisionless surgical treatment for GERD for the first
time in 2005 in Brussels, Belgium to 18 patients who were dissatisfied with
GERD medications and awaiting laparoscopic Nissen fundoplication surgery.
All patients treated with EsophyX(TM) were able to discontinue their GERD
medications after the procedure and over 80% of patients remained
completely off medication at one year post-ELF procedure. In addition, over
80% of patients were very satisfied with the procedure and would recommend
it to their family and friends. Such a high patient satisfaction with ELF
was primarily related to being free from reflux and burning pain as well as
being able to eat and drink what they wanted as a result of restoring a
robust valve at the gastroesophageal junction.
The most objective measurement of acid reflux is the pH in the
esophagus. Acidic pH in the esophagus indicates that acid is being refluxed
or regurgitated from the stomach into the esophagus. This reflux is the
typical GERD symptom experienced by millions of people world-wide as
heartburn, regurgitation or pain, which has a severe impact on the
patient's quality of life. At one year after the ELF procedure, 63% of
patients had normal esophageal pH indicating that the patients were not
experiencing reflux.
Another benefit of the EsophyX(TM) device is that it can also reduce
hiatal hernias, which occur when the stomach rises above the diaphragm and
into the chest. These hiatal hernias often cause severe GERD. In the Phase
1 study of EsophyX(TM), 76% of the patients had hiatal hernias prior to the
ELF procedure. All hiatal hernias were successfully reduced by the
EsophyX(TM) device and remained reduced at one year post-procedure.
The primary investigator for the Phase 1 study was Professor
Guy-Bernard Cadiere of the St. Pierre University Hospital in Brussels.
"This is the first endoluminal product that mimics surgery and has shown
results that approximate surgical efficacy" stated Professor Cadiere. "The
ELF procedure can also be revised or redone to tighten the newly created
gastroesophageal valve if the valve should loosen over the course of many
years. This is a big advantage over the Nissen procedure, which is
complicated and difficult to revise." Professor Cadiere has currently
performed over 65 ELF procedures using the EsophyX(TM) device. "In my
experience using EsophyX(TM)," explains Cadiere, "I have never seen the
adverse effects, like gas bloat syndrome or dysphasia that are typical of
surgical treatments."
Dr. Amin Rajan from CHIREC Hospital is the gastroenterologist partner
of Professor Cadiere who assisted in performing the ELF procedures. "I am
very impressed with the EsophyX(TM) device. We are very satisfied with the
results and patients report a dramatic quality of life improvement compared
to their life before the procedure. Patients love it and most have already
recommended it to their families and friends suffering from GERD. As a
physician representing the gastroenterology community taking care of
thousands of patients suffering from this disease, we are thrilled. We have
been waiting for an endoluminal solution for years and finally, we have one
that we can recommend to our patients."
The EsophyX(TM) device and ELF procedure have been available in Europe
since mid 2006. EsophyX(TM) is not available for sale in the U.S. at this
time.
"Surgeons have been waiting for a less invasive procedure that yields
similar results to the time tested Nissen Fundoplication," states Dr. Scott
Melvin of Ohio State University, who is on the Advisory Board for
EndoGastric Solutions(TM). "EsophyX(TM) has the potential to change how we
treat GERD."
Thierry Thaure, Chief Executive Officer of EndoGastric Solutions(TM),
states that "We are excited about this new platform technology and
anticipate that results will only improve over time as we iterate the
product and refine the procedure. This is just the beginning." Thaure
further elaborates, "We are pleased that patients can finally experience
the efficacy of surgery without skin incisions or internal incisions. We
hope this less invasive approach will allow physicians to reduce pain,
recovery time and cost of obtaining a significant anatomical 'fix' and
treat the root cause of GERD."
About GERD
GERD is acid reflux with heartburn that is frequent and severe enough
to impact daily life and damage the esophagus. Normally after swallowing, a
valve between the esophagus and stomach opens to allow food to pass into
the stomach and then closes to prevent reflux of the food back into the
esophagus. In GERD, this valve is weakened or absent, causing the acidic
digestive juices from the stomach to flow back (or reflux) into the
esophagus. This reflux is not only dangerous, because the esophagus is made
of delicate tissue that cannot withstand the caustic, acidic contents of
the stomach, but it is also painful, and 'burns' the throat (and is,
therefore, called 'heartburn'). Reflux of these stomach contents can also
lead to a precancerous condition called Barrett's esophagus and/or
adenocarcinoma, a full blown cancer that is very aggressive and deadly.
Drug Treatment of GERD
Current medical treatment of GERD includes drugs, such as H2 blockers
and proton pump inhibitors, which neutralize or suppress the stomach acid
and help relieve symptoms. However, these drugs are expensive, they don't
work for everyone, and many people who do respond quit responding over
time. Although over $13 billion is spent annually on proton pump inhibitors
alone, these drugs do not correct the root cause of GERD (anatomic
disintegration of the antireflux barrier) so symptoms return when the
medication is stopped. More effective and permanent solutions are needed.
About Surgical treatment of GERD
Surgical treatment of GERD by long, open incisions on the abdomen or by
laparoscopy (usually 5 ports or small holes in the abdomen) has long been
known to effectively treat GERD. However, this surgery is invasive, with
considerable cutting both inside the patient around the stomach area, and
on the abdominal skin. This surgery, generally called Nissen or
laparoscopic fundoplication, also causes concerns. The effectiveness of the
Nissen procedure is highly dependent on surgeon skill, as the procedure is
complicated, and effectiveness is reduced with inexperienced surgeons. The
Nissen can also cause problems if it is done too tight, and patients can
experience 'gas bloat syndrome' where they experience cramps, pain and
trapped gas. Other undesirable effects can include difficulty swallowing,
painful swallowing and/or inability to burp or vomit. Despite these
problems with the previous surgical approach (Nissen), the surgery is
generally effective at reducing reflux by creating a valve at the base of
the esophagus where it joins the stomach.
About Endoluminal Fundoplication (ELF) procedures
Until recently, the primary commercially available treatments for GERD
were medications or surgery. With the ELF procedure, an additional option
that mimics surgery but involves no abdominal or internal incisions, has
become available. The EsophyX(TM) device by EndoGastric Solutions(TM)
(EGS), is used to perform an endoluminal fundoplication (ELF). The ELF
procedure involves entering through the mouth to deliver fasteners in the
stomach with the goal of creating a 3 to 5 cm thick flap of tissue in 270
circumference at the base of the esophagus. This flap valve rests closed
against the other side of the stomach at the junction of the stomach to the
esophagus, to prevent stomach contents from refluxing back into the
esophagus. Patients who have reflux disease generally have lost this flap
valve and/or the junction of their esophagus to their stomach has stretched
out allowing food to reflux or regurgitate back into the esophagus. These
patients generally need an anatomical reconstruction to relieve their GERD
symptoms. The ELF procedure, performed using the EsophyX(TM) device, mimics
many of the principles of the laparoscopic fundoplication, including that
EsophyX(TM) reduces hiatal hernia, restores the angle of His and creates a
gastroesophageal valve. However, EsophyX(TM) does not have the same issues
with adverse effects that are seen with Nissen.
About EndoGastric Solutions
EndoGastric Solutions(TM) is a pioneer in endoluminal procedures for
the treatment of upper gastrointestinal diseases, including GERD and
obesity. EGS's mission is to utilize the most current wisdom in
gastroenterology and surgery to develop new trans-oral procedures and
products to address the largest unmet needs in gastrointestinal diseases.
EGS's initial solutions involve modifying current open surgical and/or
laparoscopic approaches using trans-oral access. The company designs and
manufactures single use instruments that will enable these incision-less
solutions, and focuses on clinically based products for use by
gastroenterologists and surgeons. EGS is a privately held corporation,
located in Redmond, Washington with a European office and distribution
center in Milan, Italy and training offices in Brussels, Belgium and
Strasbourg, France. Investors include MPM Capital, Advanced Technology
Ventures, Foundation Medical Partners, Chicago Growth Partners and Oakwood
Medical Investors.
For more information, please visit our websites at:
endogastricsolutions or EGSeurope.
EndoGastric Solutions
esophyx
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