First Incisionless Natural Orifice Surgery Completed on a Child.

10-Year-Old Boy Treated for Chronic GERD 

REDWOOD CITY, Calif. -- EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced that its innovative EsophyX([R]) device was used to complete the first ever incisionless transoral NOS surgery on a child. The 10-year-old boy had suffered from chronic GERD (gastroesophageal reflux disease) for years and was successfully treated by Todd Overcash, M.D., at Munroe Medical Center in Ocala, Florida, who performed a TIF (Transoral Incisionless Fundoplication) surgery using the EsophyX device.

The youth had been on a class of acid-blocking drugs called "PPIs" (proton pump inhibitors) for several years to treat severe acid reflux. His disease had progressed to the point where he was no longer responding adequately to the pharmacologic treatments. Although moderate to severe acid reflux, or GERD, is typically treated with medications such as PPIs and histamine receptor antagonists (H2 blockers), these drugs have side effects and can lose their effectiveness over time.

According to Dr. Overcash, the youth, who had a mature esophagus, no longer had a functional gastroesophageal valve to prevent the "reflux" of stomach acid into the esophagus. The youth's parents were also concerned about the well-known adverse effects of long-term use of PPIs, including osteomalacia (inadequate absorption of calcium and other minerals into the bones, essential to bone health).

The 30-minute TIF2 procedure, the latest procedural development made possible by the EsophyX device, was performed by Dr. Overcash using the EGS' EsophyX device to reconstruct the youth's antireflux barrier at the gastroesophageal junction, restoring its natural anatomical geometry to effectively treat GERD. Designed specially for performing incisionless reconstructive gastrointestinal procedures, the EsophyX device is introduced into the body through the mouth, rather than through an abdominal incision. The TIF procedure, which emulates the gold-standard Nissen procedure, is based on many years of proven surgical concepts and techniques. There are no external incisions or internal dissections involved in the procedure. A conventional endoscope provides visualization. The advantages of incisionless surgery over laparoscopic or open surgery include shorter hospital stay, reduced patient discomfort, shortened patient recovery, no scars, and typically higher patient satisfaction. In addition, the procedure does not alter the patient's future medical or surgical options.

The 10-year-old was discharged from Munroe Medical Center the day after the procedure. One week later his parents are reportedly still thrilled with the initial results and say their son is now completely off of PPIs.

"I have now completed over one hundred EsophyX procedures on adults with great results," said Dr. Overcash. "With the decline of Nissen Fundoplications, there needs to be a better option for patients suffering with GERD, a degenerative disease. EsophyX enables surgeons to treat this disease earlier in its progression. There is no reason we can't do the same procedure on a child with a mature esophagus. My patient was already on a triple dose of PPIs at 10 years of age, and his parents were worried about the long-term effects PPIs will have on a healthy, active boy," he added.

Thomas Krummel, M.D., the Susan B. Ford Surgeon-in-Chief at Lucile Packard Children's Hospital and Director of the Surgical Innovation Program at Stanford Medical Center, commented, "The increasing number of children and teenagers with GERD is a serious concern for parents, the medical community, society, and first and foremost, for the children and teenagers themselves. Currently, their only options are fairly significant lifestyle changes, lifelong pharmaceutical treatments, and in some cases a surgical procedure, all of which are very challenging for both the children and their parents. The EsophyX TIF procedure might be an ideal solution for some of these patients, since it provides a long-lasting restoration of the normal anatomic sphincter, allowing kids to get completely off of pharmaceuticals, and can be fine-tuned periodically throughout the life of the patient. It is the first of a new wave of incisionless natural orifice surgical procedures added to the surgeon's armamentarium. Our surgeons at both Stanford Hospital and at Lucile Packard Children's Hospital and will be starting both an adult and a pediatric program using this new technology in the very near future," he concluded.

EsophyX and StomaphyX([R]), EGS' other NOS surgical device, are the first devices to come from the proprietary NOS platform technology developed by EGS. According to the company, over the next several years the platform will spawn a number of other innovative incisionless NOS devices for treating a range of upper GI and other gastric conditions for both adults and adolescents.

"EndoGastric Solutions is very proud to have played a key role in providing a solution to what was becoming a devastating problem for this boy and his family," said Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. "GERD is a serious disease with serious consequences if not treated effectively. EGS is working with both Munroe Medical Center and Stanford to offer the EsophyX and TIF2 procedures to an increasingly diverse patient population including children and adolescents," he added.

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) and other GI conditions. EsophyX([R]) and StomaphyX([R]) are cleared by the FDA, CE marked, and available for sale in the U.S. and other parts of the world.

For more information about EndoGastric Solutions, Inc., EsophyX and StomaphyX please visit:

US: http://www.endogastricsolutions.com/

EU: http://www.egseurope.eu/

Other locations: http://www.egsglobal.net/