FDA 510(k) Clears Next-Generation Version of EndoGastric Solutions’ EsophyX® Device

by Business Wire

REDMOND, Wash.--()--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EsophyX® Z device.

Designed for compatibility with the company’s existing 7.5 mm SerosaFuse® Implantable Fastener cartridges, EsophyX Z allows physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle, making the device similar to stapler like devices often utilized in surgery.

EsophyX Z will enter a limited release in the U.S. before full commercialization during the summer. Additionally, it is being 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 with the EsophyX® device.

“The EsophyX Z design provides reduced, device operational steps,” said Darren Crow, General Manager, EndoGastric Solutions. “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.”

We gained significant insights from our physicians that aided in the roadmap for this product upgrade, and we are truly grateful for their contributions,” said Skip Baldino, President and CEO of EndoGastric Solutions. “The EsophyX Z clearance represents another proud milestone in EGS’ mission to provide physicians with the tools they need to more effectively treat the root cause of GERD and want a safe, proven, incisionless alternative to surgery.”

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