The FDA has issued 510k clearance to Apollo Endosurgery’s Overstitch Sx, a new full-thickness endoscopic suturing system for bariatric and gastrointestinal procedures, which works with a wider range of endoscopes than the current product model, the company announced.
The current version of Overstitch only works with a limited number of dual channel endoscopes, while the new model is compatible with most single channel endoscopes with diameters ranging from 8.8 mm to 9.8 mm, according to a press release.
“Once available, the combination of the current version of OverStitch and OverStitch Sx will provide most physicians with access to the benefits of full-thickness flexible endoscopic suturing regardless of their hospital’s selection of endoscopic capital equipment or endoscope manufacturer,” per the press release.
“Endoscopic suturing is quickly becoming a global standard of care for a variety of endoscopic procedures backed by a growing level of clinical evidence,” Christopher Gostout, MD, chief medical officer at Apollo Endosurgery, said in the press release. “The launch of OverStitch Sx will allow suturing technology to be available to nearly any physician with access to an endoscope. Broader physician access to endoscopic suturing allows for greater patient access to a variety of minimally invasive endoscopic treatments.”
The company expects to launch the new system in the U.S. and Europe in the first half of 2018, according to the press release.
As Healio Gastroenterology and Liver Disease previously reported, the AGA and Apollo Endosurgery recently announced the launch of a clinical registry that will track outcomes of trans-oral endoscopic suturing procedures performed with the OverStitch system.
Disclosures: Gostout is employed by Apollo Endosurgery.