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Product approval

Apollo gains FDA approval for Polypropylene Suture-Anchor Assembly

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 Endosurgery has received 510(k) clearance from the 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.  The comapny 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,” stated Todd Newton, Apollo’s Chief Executive Officer. “This will be key as we seek to expand into new OverStitch markets outside the US.”

The OverStitch and OverStitch Sx endoscopic suturing systems enable advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. According to the company, this 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.

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