The FDA has awarded Endogastric Solutions clearance to introduce the company’s EsophyX Z device. It’s intended for performing reconstructions of the gastroesophageal valve to prevent acids from coming up into the esophaus.
The device works with the firm’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges. These are placed by squeezing the trigger handle just like many staple-like surgical instruments.
The EsophyX Z will be widely available in the U.S. later in the summer following a limited initial launch.
“The EsophyX Z design provides reduced, device operational steps,” said Darren Crow, General Manager, EndoGastric Solutions, in a statement. “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,” added 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: EndoGastric Solutions…