REDMOND, Wash.--(BUSINESS WIRE)--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.
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“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.”
About EsophyX® technology
The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z, in 2015. The technology has continued to evolve and is a clinically backed tool for physician use in the treatment of GERD. 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.
Indications:
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
