Apollo Endosurgery Receives FDA Clearance for Polypropylene Suture-Anchor Assembly


Apollo Endosurgery Inc, a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced that it has received 510(k) clearance from the U.S. FDA for its Polypropylene Suture-Anchor Assembly for use specifically with the OverStitch Endoscopic Suturing Systems. This proprietary suture-anchor implant is used as part of Apollo’s OverStitch™ and OverStitch Sx Endoscopic Suturing Systems to pass and anchor suture in the gastrointestinal tract.

Apollo is currently distributing a suture anchor that is manufactured by a third party according to Apollo design specifications. “Obtaining 510(k) clearance for our own proprietary suture-anchor component is expected to improve our gross margins, and allow us greater control over the supply of our suture by reducing our dependency on third party suppliers. This will be key as we seek to expand into new OverStitch markets outside the United States,” stated Todd Newton, Apollo’s Chief Executive Officer.

About OverStitch and OverStitch Sx
The OverStitch and OverStitch Sx endoscopic suturing systems enable 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 a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures. For more information regarding OverStitch go to: www.apolloendo.com.

About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies to treat various gastrointestinal conditions, ranging from gastrointestinal defect repairs to the interventional treatment of obesity. 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 70 countries today and include the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.