Noninvasive Device For GERD, Obesity Developed

“Gastroesophageal-reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care 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, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-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 – a condition in which a patient’s gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus – the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. 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.

Filipi spoke about the device, which could be available for human trials later this year, on May 19, at the 49th annual Digestive Disease Week in San Diego, Calif.