Apollo Endosurgery, Inc. (NASDAQ: APEN), shares dropped -4.28% to 3.800 in the early morning today as the global leader in minimally invasive surgical methods announced that the X-Tack Endoscopic HeliX Tacking System had received 510(k) clearance from the U.S. Food & Drug Administration.
The X-Tack is a brand new through-the-scope, a suture-based device designed specifically to treat gastrointestinal problems in the lower gastrointestinal tract with applications in the upper gastrointestinal tract.
X-Tack allows physicians to solve challenges commonly encountered when closing irregularly shaped or large defects. This procedure involves suture-tethered HeliX tacks, positioned independently in adjacent healthy tissue, and are then cinched to close the construct. The X-Tack system answers a long-expressed need for advanced closure devices to improve healing and prevent adverse events after colonic polypectomy and mucosal resections, such as delayed bleeding or perforation.
A limited launch with gastroenterologists will be initiated in January 2021 to be followed by a full launch late in the first quarter of 2021.