Apollo Endosurgery Receives FDA Clearance for OverStitch™ Sx Endoscopic Suturing System
AUSTIN, Texas — (BUSINESS WIRE) — Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive surgical medical devices for bariatric and gastrointestinal procedures, announced today U.S. Food and Drug Administration 510k 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, MD, 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 US and Europe in the first half of 2018.
The OverStitch™ Endoscopic Suturing System is intended for endoscopic placement of sutures and approximation of soft tissue. OverStitch™ enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and facilitates a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. For more information regarding OverStitch™ go to: apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal disorders. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 80 countries today.
Apollo’s common stock is traded on NASDAQ Global Market under the symbol “APEN.” For more information regarding Apollo Endosurgery, go to: apolloendo.com.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: price levels for established and innovative medical devices compared to the costs of procedures utilizing our products; developments in medical technology; regulatory approvals; reimbursement decisions by private or government payors or other government actions; physician adoption and recommendations of procedures utilizing our products; misuse or off label use of our products by physicians and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the three months ended September 30, 2017. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.