Apollo Endosurgery Gets FDA Clearance for Polypropylene Suture-Anchor Assembly

Apollo Endosurgery (NASDAQ:APEN) has announced it has received 510(k) clearance from the US Food and Drug Administration for its polypropylene suture-anchor assembly for use with the overstitch endoscopic suturing systems.

As quoted in the press release:

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.

Click here to read the full press release.