NEXT GENERATION PLATFORM CREATES TRANSORAL ANTERIOR FUNDOPLICATION FOR GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Prof. Horgan, Santiago, UC San Diego Health System, San Diego, United States of America; Prof. Mintz, Yoav, Hadassah Hebrew University Medical Center, Jerusalem, Israel; Sonnenschein, Menashe, Medigus Ltd, Omer, Israel; Govrin, Amir, Medigus Ltd, Omer, Israel

Presented at EAES 2014 Amazing Technologies Session.

Background

GERD treatments are evolving toward endoscopic solutions

Aim

Transoral stapling procedure to restore functional flap valve

Project description

Flexible endostapler (15.5mmOD) with CMOS miniature camera and LED illumination provides 140º FOV with HDMI output, without separate endoscope. As stapler tip is retroflexed, stomach and esophageal tissues are compressed. Ultrasonic guidance automatically activates to replace direct visualization. User interface illustrates distance between staple cartridge and anvil from initial tissue contact to full compression (50micron accuracy).

Motorized staple ejection delivers five 4.8mm titanium staples, positioned 3cm proximal to GEJ. Alignment mechanisms ensure reliable closure and staple formation. Insufflation controls mitigate risk of air leaks. Software controls minimize user errors. The device is reloaded for additional stapling, to recreate a structural flap valve.

Preliminary Results

Previous system studied in 69 subjects. New MUSE system has CE Mark and FDA clearance. Evaluation of new system performance in a larger number of patients planned.