Apollo Endosurgery announced FDA clearance for endoscopic suturing system





Apollo Endosurgery Inc. announced that FDA has cleared a 510(k) application to market its OVERSTITCH™ endoscopic suture system. The OVERSTITCH system is a single-use device that fits onto standard flexible endoscopes and enables physicians to place full thickness running or interrupted sutures into targeted tissues.

 

Dr. Santiago Horgan, Director of Minimally Invasive Surgery and the Center for the Future of Surgery at the University of California San Diego explained, Adapting suturing to a standard flexible endoscope platform is a major accomplishment” explained Dr. Santiago Horgan, Director of Minimally Invasive Surgery and the Center for the Future of Surgery at the University of California San Diego.

Dr. Jeffrey Marks, Associate Professor in the Department of Surgery at University Hospitals Case Medical Center said, The capability to suture endoscopically makes the device a valuable tool for a variety of endolumenal GI procedures. The use of a tool like the OVERSTITCH system will enable the advanced endoscopist to perform more aggressive procedures such as EMR and full thickness resection.

The OVERSTITCH endoscopic suture system is a fully disposable suturing system that allows a physician to use a standard flexible endoscope to place sutures. The device quickly mounts to common therapeutic endoscopes and is designed to safely navigate through delicate areas of the anatomy. Once at the surgical site, custom needle-suture sets—available with standard absorbable and non-absorbable materials up to 2-0 in thickness—can be loaded and reloaded without removing the device or the endoscope. The physician can then place either an interrupted or running stitch which can be secured with an included cinching device or by using the device itself to tie a surgical knot.

Dennis McWilliams, CEO of Apollo Endosurgery, The 510(k) clearance of the OVERSTITCH endoscopic suture system is a significant step towards making the benefits of endolumenal surgery a realistic therapeutic option in hospitals and clinics across the country.