World's First Endoluminal Fundoplication

Brussels team performs world's first endoluminal fundoplication (100% trans-oral incision-less) with clinical aim of curing gastroesophageal reflux disease (GERD).


Press Release

EndoGastric Solutions Incorporated, the world leader in endoluminal reconstructive gastric procedures, announced that a clinical team led by Professor Guy-Bernard Cadiere from the University of Brussels performed the first 100% trans-oral incision-less fundoplication procedures. In recent months, 7 patients with severe gastroesophageal reflux disease (GERD) were successfully treated with this new device and procedure, which involves inserting a device through the mouth and into the stomach to access and reconstruct the gastroesophageal valve, thereby preventing reflux of stomach contents into the esophagus and throat. Since there currently are no effective methods of curing GERD without abdominal incisions and surgical manipulation of the stomach and esophagus, performance of these procedures represents a significant medical advancement.

"This is as exciting as when Professor Bernard Dallemagne and I performed the first Laparoscopic Nissen Fundoplication," remembers Cadiere. "We were able to successfully perform these incision-less endoluminal fundoplication procedures in all patients, and we constructed 4-5 centimeter, 270 degree, perfectly Omega-shaped valves. Other companies have attempted to come up with minimally invasive endoscopic approaches to GERD treatment, but none of their products worked very well because they did not increase the competence of the gastroesophageal valve and antireflux barrier. EndoGastric Solutions' approach has the highest likelihood of success because it mimics a procedure that has been the standard of care for over 20 years and has proven long-term results. In these 7 patients, we essentially created the same robust valve we do in a Nissen fundoplication -- so we expect, conceptually, this should hold up as well as the Nissen, which is the gold standard for efficacy. All 7 patients are off their proton pump inhibitor drugs at 4 weeks post-procedure, despite having been on high dose drugs before the procedure. Endoscopies at 4 weeks post-procedure show good results and no esophagitis. We are very enthusiastic about the quality of life that these patients have already, but we cannot call this a cure for GERD, until we see how well the results are maintained after 3 and possibly 6 months."


About the Endoluminal Fundoplication Procedures

"EndoGastric (EG) Solutions has developed products and new procedures enabling the treatment of GERD by improving the gastroesophageal valve while accessing it via the esophagus -- with no incisions in the skin at all," stated Dr. Stefan Kraemer, Founder and Chief Medical Officer of EG Solutions. Dr. Kraemer trained under Prof. Lucius D. Hill, a luminary in GERD treatment, and the only American surgeon, who conceived a validated, efficacious surgical antireflux procedure with documented 25-year track-record. "The important thing is that we are using proven techniques and methodologies, such as the manipulations of the gastroesophageal valve as they are performed during surgery, without cutting through the abdominal wall," reports Dr. Kraemer. "We have based our procedure on the well reported and proven evidence, that all surgical procedures create a robust antireflux valve and are being strongly supported herein by outstanding scientific advisors and the Belgian team. EndoGastric Solutions has modified these techniques. The EsophyX device and procedure allow surgeons and gastroenterologists to work together with trans-oral access to shape the antireflux valve."

"Our EsophyX device and procedure addresses the root cause of GERD by stopping reflux and regurgitation through the restoration of the gastroesophageal valve," says Dr. Kraemer. "Medication only neutralizes acid in the digestive juice but enzymes, bile and other noxious compounds of the gastric chyme are not affected. Regurgitation and all of its negative side effects remain. Open and laparoscopic surgery, however, have a proven track record of dramatically reducing or eliminating reflux and regurgitation."

"This is a major milestone for EndoGastric Solutions," says Thierry Thaure, CEO of EG Solutions. "We are a very clinically based company, and are excited about working with the best gastroenterologists and surgeons in the US and Europe to perfect this procedure and the technology. Professor Cadiere and his team did an excellent job on these procedures." "We are very encouraged about the clinical improvements these patients have seen already, even in the early days after treatment," states Professor Cadiere.


About EndoGastric Solutions EndoGastric Solutions (EG Solutions) is a pioneer in endoluminal procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and obesity. EG Solutions' 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. EG Solutions' 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. Although none of EG Solutions' products are commercially available yet, EG Solutions is performing endoluminal fundoplications in clinical studies in patients in Europe. EG Solutions is a privately held corporation, located in Redmond, Washington. The company was originally founded as EsophyX Inc. and recently was renamed to EndoGastric Solutions. Investors include MPM Capital, Advanced Technology Ventures, and Foundation Medical Partners.


SOURCE: EndoGastric Solutions Inc.
Web Site: http://www.esophyx.com