FDA Clears Next-Generation Version of EndoGastric Solutions’ EsophyX Device

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to EndoGastric Solutions Inc.’s 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 United States 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.
 
“The EsophyX Z design provides reduced, device operational steps,” said Darren Crow, general manager of EndoGastric Solutions (EGS). “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.”
 
The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z, 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 Gastroesophageal Reflux Disease (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.
 
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal (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 ≤ 2 cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
 
Performed without the need for external incisions through the skin, the Transoral Incisionless Fundoplication (TIF) procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily medications to control symptoms.
 
More than 17,000 TIF patients have been treated worldwide since EsophyX device clearance in 2007. More than 60 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients.
 
Gastroesophageal reflux disease is a chronic condition in which the gastroesophageal valve allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
 
GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the United States. It is estimated that pain and discomfort from acid reflux impacts more than 80 million people at least once per month in the United States. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.
 
Based in Redmond, Wash., EndoGastric Solutions develops and commercializes evidence-based, incisionless surgical technology for the treatment of GERD.