FDA Clears EndoGastric Solutions’ Next Generation EsophyX® Device

EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), says the U.S. FDA has granted 510(k) clearance for the EsophyX® Z device.

Background

The Transoral Incisionless Fundoplication (TIF®) procedure offers patients who require an anatomical repair an incisionless treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophagitis is eliminated, with most patients able to stop using daily PPI medications to control symptoms.

The original EGS EsophyX device was cleared by the FDA in 2007 with a third generation device, the EsophyX Z, introduced in 2015. The EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes — including low profile and larger high-definition models — to treat the underlying anatomical cause of GERD. The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope.

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.

EGS says 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.

Company comments

“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.”

Source: Business Wire

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