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Apollo submits X-Tack Endoscopic HeliX Tacking System for FDA approval

Tue, 07/21/2020 - 15:49
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Apollo Endosurgery has submitted a 510k submission of the X-Tack Endoscopic HeliX Tacking System to the FDA seeking clearance for the new, through-the-scope, suture-based device designed specifically for closing defects in the lower gastrointestinal tract with additional applications in the upper gastrointestinal tract.

"Endoscopists have long expressed a desire and need for improved and more robust closure devices, especially for tissue defects created during resection or dissection procedures in the colon. X-Tack was designed to meet this need and provide endoscopists with an advanced suture-based tool to address potential complications and risks following an endolumenal procedure such as the risk of delayed bleeding," stated Todd Newton, Apollo's Chief Executive Officer. "X-Tack will expand our endolumenal portfolio with a solution for the lower GI tract. Additionally, we expect X-Tack will have application during certain upper gastrointestinal procedures as well."

Designed for compatibility with market leading gastroscopes and colonoscopes, X-Tack can be implanted using any working channel. Therefore, physicians will have on-demand access to the benefits of through-the-scope, suture-based fixation during their upper or lower gastrointestinal therapeutic procedures.

The X-Tack device enables physicians to place a series of individual HeliX Tacks into healthy tissue adjacent to a defect. Each HeliX Tack is tethered with a single polypropylene suture. Pulling tension on the suture approximates the HeliX Tacks and in turn closes the tissue defect. A suture cinch is then used as the final step to secure the suture in place. Because it offers multiple points of fixation, the X-Tack is expected to enhance a physician's ability to address the closure challenges of commonly encountered large or irregularly shaped defects.

"Depending on a lesion's size, shape and location in the gastrointestinal tract, closing a resection site can often be challenging for an endoscopist," said Dr Andrew Storm, , Assistant Professor of Medicine and Advanced Endoscopist at Mayo Clinic in Rochester, MN. "The X-Tack System successfully addresses a number of these challenges and makes difficult or previously impossible closures both feasible and more efficient for physicians - it combines the convenience of a clip with the flexibility of suturing through a standard gastroscope or colonoscope."

Approximately 20 million endoscopic procedures are performed in the US every year in the lower gastrointestinal tract. With the increasing rate of colonoscopy screenings, improved technology for early cancer detection, and growth in therapeutic treatments, endoscopic removal of benign colorectal lesions provides a minimally invasive, cost effective alternative to surgery.