Endoluminal Fundoplication in Europe (reflux)

EndoGastric Solutions(TM) Announces 80% Success Rate Of Their Endoluminal Fundoplication (ELF) Procedure Using The EsophyX(TM) Device

"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."

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Another source of information is available at Wikipedia.org :

Endoluminal Fundoplication
"In June 2006 EndoGastric Solutions introduced EsophyX ELF in the Europe Union as an alternative to surgical and pharmaceutical approaches for the treatment of GERD. EsophyX ELF is intended to deliver similar benefits as the time-proven laparoscopic fundoplication procedures, by reducing hiatal hernia, recreating the Angle of His, and creating a GastroEsophageal Valve (GEV). The key differences are that EsophyX ELF is an endoscopic non-invasive procedure that is performed transorally (through the mouth), does not require incisions, and does not dissect any part of the natural anatomy.

Previous endoluminal treatments focused predominantly on the LES. However, failure to effectively treat reflux long-term with endoluminal therapies which focused only on the Lower Esophageal Sphincter (LES) combined with the fact that surgical approaches like Nissen fundoplication recreate the GEV and have excellent long-term efficacy, has led to an awareness that the GEV is probably the most powerful component of the Anti-Reflux Barrier. The device has been designed to deploy multiple tissue fasteners to create a robust and durable valve and is intended to restore the geometry of the GastroEsophageal Junction and recreate the natural, unidirectional valve mechanism necessary to prevent GERD. EsophyX ELF has not been cleared by the US FDA and is not yet available in the US."

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