FDA Clears Apollo Endosurgery’s OverStitch Sx Endoscopic Suturing System

Apollo Endosurgery Inc., a developer of less invasive surgical medical devices for bariatric and gastrointestinal procedures, announced U.S. Food and Drug Administration 510(k) clearance of the OverStitch Sx, a new, full-thickness flexible endoscopic suturing system that will work on a broad range of single-channel flexible endoscopes.
 
Flexible endoscopic suturing using Apollo’s current version of OverStitch is an important tool for both surgeons and gastroenterologists, but it is currently only compatible with a limited number of dual channel endoscopes and physicians without access to this specific capital equipment cannot leverage the benefits of endoscopic suturing.
 
OverStitch Sx removes this access limitation, and will be compatible with most single channel endoscopes with diameters ranging from 8.8 mm to 9.8 mm. 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.
 
The OverStitch Sx, in addition to broadening endoscope compatibility, is expected to provide optimal visualization and maneuverability for the physician.
 
“Endoscopic suturing is quickly becoming a global standard of care for a variety of endoscopic procedures backed by a growing level of clinical evidence. The launch of OverStitch Sx will allow suturing technology to be available to nearly any physician with access to an endoscope,” said Christopher Gostout, M.D., chief medical officer at Apollo Endosurgery. “Broader physician access to endoscopic suturing allows for greater patient access to a variety of minimally invasive endoscopic treatments.”
 
Apollo plans to introduce the Sx system in the U.S. and Europe in the first half of 2018.