Apollo Endosurgery has announced the publication of supporting pre-clinical results for the X-Tack Endoscopic HeliX Tacking System, a through-the-scope, suture-based device designed specifically for closing and healing defects in the upper and lower gastrointestinal (GI) tract. This closure system improves healing and address potential adverse events, such as delayed bleeding and perforation, that can occur following colonic polypectomy and mucosal resections.
According to the company, the X-Tack device enables physicians to reliably overcome the challenges commonly encountered when closing large or irregularly shaped defects. The outcomes were published in the paper, ‘Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model’, was published in Endoscopy International.
Researchers from the Mayo Clinic Developmental Endoscopy Research Unit led by Dr Andrew Storm, Assistant Professor of Medicine and Advanced Endoscopist at Mayo Clinic in Rochester, MN, sought to compare technical success of closure using a novel through-the-scope (TTS) tissue helix tack and suture device (X-Tack) to TTS clips in a porcine model and compare rates of mucosal defect healing over four weeks.
Four subjects underwent 40 mucosal resections, diameter range 25-50 mm, in the stomach n= 24) and colon (n=16). Closures were randomised to X-Tack (n=24) or clip (n=16). Animals underwent weekly endoscopic follow-up for four weeks.
The outcomes showed that technical closure with X-Tack was successful in 24 of 24 (100 %) cases and with clips in 13 of 16 cases (81.3 %) (p=0.0001). One colonic perforation occurred and was successfully managed using X-Tack. The rate of healing was not statistically different between the groups, and all sites healed at four weeks including the perforation and were confirmed by histology.
However, defects that could not be closed with TTS clips, due to the size or geometry of the defect, were successfully closed with X-Tack. The X-Tack results, for both lower and upper gastrointestinal sites, were consistent with complete healing.
“In conclusion, X-Tack is superior for acute closure of large resection defects compared to TTS clips in a porcine model, with similar rates of healing at 4 weeks,” the authors concluded. “The perceived advantages of X-Tack over current large defect closure devices include relative simplicity and accuracy of use, without the need for endoscope withdrawal for device loading, and the ability to close larger lesions when TTS clips are inadequate.”
"Building off our pre-clinical experience, we began integrating X-Tack into our clinical practice early this year and are very encouraged by clinical use of the device to date. Not only has X-Tack performed as intended for closure of standard mucosal defects after polypectomy, but also in very large resection site closure, for closure of perforations of the GI tract, and across a range of other interventions and indications," said Storm. "Most importantly, we are using the device to the benefit of patients who would not have been candidates for other closure techniques due to complex anatomy, size of the defect, or other reasons. Our preclinical study, as well as a step-by-step instructional video and case report using X-Tack were recently published to share our experience with other endoscopists who are planning to integrate X-Tack into their clinical practice."
"X-Tack offers physicians a powerful and easy to use tool to help improve clinical outcomes for their patients," said Chas McKhann, CEO and President at Apollo Endosurgery. "We are continually listening to what physicians need, and we are proud to now offer a suite of ground- breaking tools, including X-Tack and our OverStitch platform, to improve closure and approximation of soft tissue throughout the upper and lower GI tract."
Following successful completion of a limited launch with select gastroenterologists in the first quarter of 2021, X-Tack is now available for sale in the US, the company revealed.
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