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FDA clears next-generation EsophyX device for GERD
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The FDA has granted 510(k) clearance to the EsophyX Z device, which requires fewer steps for transoral incisionless fundoplication procedures to treat gastroesophageal reflux disease, the manufacturer announced.
EsophyX (EndoGastric Solutions) is used to performed transoral incisionless fundoplication (TIF) to reconstruct the gastroesophageal valve and restore its barrier function to prevent reflux in patients with GERD. The original EsophyX device was cleared by the FDA in 2007 and the third generation device was launched in 2015.
The new version of the device enables physicians to reconstruct the gastroesophageal valve and secure tissue using a trigger-like handle, similar to stapler-like devices used in surgery, according to the press release. It was designed to be compatible with the company’s 7.5 mm SerosaFuse Implantable Fastener cartridges.
“The EsophyX Z design provides reduced, device operational steps,” Darren Crow, general manager of EndoGastric Solutions, said in a press release. “In addition to a reduction in fastener deployment steps, the stylet tips on exiting the device are now shrouded at the tip of the tissue mold.”
The device will have a limited release in the U.S. before full commercialization in the summer. It is also being used in the AGA’s STAR Registry to provide real-world data comparing outcomes between TIF and traditional laparoscopic surgery.
Disclosures: Crow is employed by EndoGastric solutions.