Medical technology firm Apollo Endosurgery has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its polypropylene suture-anchor assembly, which is designed specifically for use with the OverStitch endoscopic suturing systems.
The suture-anchor implant has been designed for use as part of Apollo’s OverStitch and OverStitch Sx endoscopic suturing systems to pass and anchor suture in the gastrointestinal tract.
Apollo Endosurgery currently distributing suture anchor produced by third party
At present, the company is distributing a suture anchor, which is produced by a third party according to Apollo design specifications.
OverStitch and OverStitch Sx endoscopic suturing systems will allow advanced endoscopic surgery by enabling physicians to place full-thickness sutures from a flexible endoscope.
The new technology allows a secure approximation of tissue endoscopically, as well as helping to offer a range of less invasive solutions for physicians treating defects in both the upper and lower GI tract of their patients.
In addition, physicians are leveraging endoscopic suturing to carry out a variety of advanced bariatric procedures.
Apollo Endosurgery CEO Todd Newton said: “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.”
Apollo Endosurgery is involved in the development of less invasive therapies for the treatment of various gastrointestinal conditions ranging from gastrointestinal defect repairs to the interventional treatment of obesity.
The company’s device-based therapies serve as an alternative to invasive surgical procedures, enabling users to reduce complication rates and total healthcare costs. Apollo markets its products in more than 70 countries across the world.
