The US Food and Drug Administration (FDA) has granted 510(k) clearance for US-based medical device company EndoGastric Solutions’ (EGS) EsophyX Z device to treat gastroesophageal reflux disease (GERD).
The new device is compatible with EGS’ existing 7.5 mm SerosaFuse implantable fastener cartridges and it 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 used in surgery.
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EndoGastric Solutions general manager Darren Crow said: "The EsophyX Z design provides reduced, device operational steps.
"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."
Surgeons and gastroenterologists can leverage on the EsophyX technology to use a wider range of endoscopes including low-profile and larger high-definition models to treat the anatomical cause of GERD.
GERD is a chronic condition in which the gastroesophageal valve (GEV) causes a reflux (wash backwards) of gastric contents into the esophagus triggering heartburn and a potential esophageal lining injury.
More than 80 million people in the US are estimated to be affected by pain and discomfort from acid reflux.
EGS’ EsophyX Z device reconstructs the gastroesophageal valve (GEV) to restore its function of preventing stomach acids refluxing back into the esophagus.
The device is inserted through the patient’s mouth with direct visual guidance from an endoscope.
The American Gastroenterological Association’s STAR Registry is currently testing the device’s efficacy while being used in the traditional laparoscopic surgery and transoral incisionless fundoplication (TIF) procedure for reflux.
Image: The EsophyX Z device. Photo: courtesy of EndoGastric Solutions, Inc.
