New Noninvasive Device for GERD, Obesity

A new, noninvasive gastroplasty device to treat two separate disorders – gastroesophageal reflux disease (GERD) and morbid obesity – was reported by its inventor, Charles J. Filipi, MD, professor of surgery at Creighton University School of Medicine.

Filipi spoke about the device, which could be available for human trials later this year, on Monday, May 19, at the 49th annual Digestive Disease Week in San Diego, Calif. The meeting is considered the largest and most prestigious meeting worldwide on digestive diseases.

"Gastroesophageal reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of healthcare in the United States," Filipi said. "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."

Typically, operations for GERD or obesity are performed using incisions. This requires hospitalization and creates the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is three feet long and less than 4/5 of an inch in diameter, avoids the need for incisions, Filipi noted.

To treat obesity, Filipi's device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach’s two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach "pouch" that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.

To treat GERD, the device is inserted through the mouth and esophagus until it reaches the esophageal junction. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.

SafeStitch Medical Inc., a publicly traded medical-device company based in Miami, is developing Filipi’s device with licensed intellectual property from Creighton University. Filipi is medical director for SafeStitch.

Source: Creighton University