Medical device company EndoGastric Solutions (EGS) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation EsophyX Z device.
Compatible with the company’s existing 7.5 mm SerosaFuse implantable fastener cartridges, the EsophyX Z enables physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle.
In 2007, the company received FDA approval for the original EsophyX device.
EsophyX is a clinically backed tool designed for physicians to use in the treatment of gastroesophageal reflux disease (GERD).
It allows surgeons and gastroenterologists to use a range of endoscopes, including low profile and larger high-definition models, to treat the underlying anatomical cause of GERD.
The technology will be used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, avoiding stomach acids refluxing back into the esophagus.
EndoGastric Solutions president and CEO Skip Baldino said: "We gained significant insights from our physicians that aided in the roadmap for this product upgrade, and we are truly grateful for their contributions.
"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."
The company said the EsophyX Z will enter a limited release in the US before full commercialization during the summer.