Next-Gen Version of EsophyX Device Set for Limited Market Release

EndoGastric Solutions, a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), has announced the first use of the recently cleared EsophyX Z Fastener Delivery System during a Transoral Incisionless Fundoplication (TIF) procedure at UC Irvine Health in Irvine, CA.

Interventional Gastroenterologist Kenneth Chang, MD, executive director of the UC Irvine Health H.H. Chao Comprehensive Digestive Disease Center, performed the TIF procedure using the new EsophyX Z device, which was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) earlier this month.

“There are certain GERD patients who don’t respond effectively to medical management with proton pump inhibitors,” said Dr. Chang. “Long-term data continue to demonstrate the positive impact the TIF procedure for reflux has in controlling chronic, troublesome GERD symptoms.”

The TIF procedure using the EsophyX Z device allows physicians to reconstruct the gastroesophageal valve by performing a partial fundoplication, transorally, and securing the gastric tissue with fewer procedural steps.

“This marks another notable milestone for EGS as we continue to address the significant problem of GERD and focus on filling the treatment gap between medication and more invasive surgery,” said Skip Baldino, President and CEO of EndoGastric Solutions.

EsophyX Z, which is designed for compatibility with the company’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges, will enter a limited U.S. release before full commercialization this summer.

The device will also be used in the American Gastroenterological Association’s STAR Registry, which will provide the first real-world data comparing patient outcomes after traditional laparoscopic surgery and TIF procedure with the EsophyX device.

Inanimate model demonstrations of the EsophyX Z device took place during Digestive Disease Week (DDW) 2016 annual meeting at the San Diego Convention Center. New meta-analysis data on the TIF procedure was also presented at the meeting.