Gastroesophageal reflux disease (GERD) device specialist EndoGastric Solutions (EGS), has announced the first use of the recently cleared EsophyX® Z Fastener Delivery System (EsophyX® Z device) during at UC Irvine Health in Irvine, CA.
Background
A couple of weeks ago we covered the U.S. FDA clearance of EndoGastric Solutions®’ next generation EsophyX® Z Fastener Delivery System for Transoral Incisionless Fundoplication (TIF®). Now the company tells us of the start of its product roll-out in the U.S. Interventional Gastroenterologist Kenneth Chang, MD, executive director of the UC Irvine Health H.H. Chao Comprehensive Digestive Disease Center, performed the TIF procedure.
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.
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 during the summer of 2016. 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.
Physician comments
“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.”
Company comments
“We are excited and honored to have Dr. Chang perform the first TIF procedure using the new EsophyX Z device via the TIF 2.0 procedure to treat a chronic GERD patient,” said Skip Baldino, President and CEO of EndoGastric Solutions. “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.”
Source: Business Wire
published: May 27, 2016 in: Gastroenterology, Launches / Withdrawals