Friday, June 29, 2018
Apollo Endosurgery, Inc., a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that it has received Special 510(k) clearance from the U.S. Food and Drug Administration for OverStitch™ Sx Endoscopic Suturing System.
The OverStitch Sx System, a new, full-thickness flexible endoscopic suturing system, received initial 510(k) clearance in November 2017. The Special 510(k) addressed an accessory to the system that is intended to ease the attachment of the device to compatible endoscopes (single-channel endoscopes with diameters ranging from 8.8mm to 9.8mm). The Special 510(k) clearance is the last regulatory requirement needed prior to the system’s introduction into the US market.
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 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.
