FDA approves flexible endoscopic suturing system — 4 insights

The FDA awarded Apollo Endosurgery's OverStitch Sx system FDA 510(k) clearance.

Here's what you should know:

1. OverStitch Sx is an endoscopic suturing system that works with several single-channel flexible endoscopes.

2. The existing version of OverStitch was only compatible with a limited number of dual-channel endoscopes. OverStitch Sx eliminates that limitation.

3. Specifically, OverStitch Sx works with most single-channel endoscopes with diameters between 8.8 mm and 9.8 mm.

4. The Sx system will be available in the U.S. and Europe in the first half of 2018.

Apollo Endosurgery's CMO Christopher Gostout said, "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. Broader physician access to endoscopic suturing allows for greater patient access to a variety of minimally invasive endoscopic treatments."

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