EndoGastric Solutions said this week it launched the EsophyX Z+ device designed for use in transoral incisionless fundoplication procedures to reconstruct the gastroesophageal valve to treat patients with severe gastroesophageal reflux disease.
The device is designed to be used with a partial fundoplication technique that secures tissue with dual deployment of SerosaFuse implantable fasteners, the Redmond, Wash.-based company said.
EndoGastric Solutions’ EsophyX Z+ was used in its first TIF 2.0 procedure by Dr. Michael Murray of the Northern Nevada Medical Center and Dr. Kenneth Chang of UC Irvine Health, according to a press release.
“GERD is a chronic condition and proton pump inhibitors do not control symptoms in about one-third of patients. The design of the new EsophyX Z+ device makes performing TIF 2.0 procedures technically easy and produces a consistent and effective fundoplication thus providing an effective alternative to prescription medications and traditional surgical procedures,” Dr. Murray said in a press release.
“The robust collection of clinical data and recent positive policy coverage announcements support the TIF 2.0 procedure as an established treatment option for patients who wish to eliminate or discontinue PPI use and avoid surgery for acid reflux. This newest design iteration allows for maximal visibility using a standard endoscope combined with almost effortless and confident deployment of fasteners. GI endoscopists and surgeons should consider the TIF procedure in patients seeking a less invasive, proven GERD treatment solution,” Dr. Chang said in a prepared statement.
The original version of the EsophyX device was cleared by the FDA in 2007, with the third generation Z model launched in 2015. The new Z+ device allows for a wider selection of endoscopes to be used to treat the anatomical causes of GERD.
“We are excited to launch the EsophyX Z+ device as we believe it will further enhance the physician’s technical experience. At EndoGastric Solutions, we are committed to addressing the unmet needs in gastrointestinal diseases and offering physicians highly effective options that fill the significant treatment gap between medication and more invasive surgery,” prez & CEO Skip Baldino said in a prepared release.
Earlier this month, EndoGastric Solutions said that new Medicare Administrative Contractors Noridian Health Care Solutions and National Government Services were granted reimbursement access for the transoral incisionless fundoplication procedure using its Esophyx device.