FDA clears Apollo Endosurgery’s X-Tack Endoscopic HeliX Tacking System

Apollo Endosurgery has gained FDA 510k clearance of the X-Tack Endoscopic HeliX Tacking System, a new, through-the-scope, suture-based device designed specifically for closing and healing defects in the lower gastrointestinal tract with additional applications in the upper gastrointestinal tract.

X-Tack Endoscopic HeliX Tacking System

According to the company, the X-Tack device enables physicians to easily address the challenges commonly encountered when closing large or irregularly shaped defects. The procedure involves suture-tethered HeliX Tacks, independently positioned into healthy tissue adjacent to a defect, then cinched to close the construct. X-Tack fulfills a long-expressed need for advanced closure devices to improve healing and address potential adverse events that can occur following colonic polypectomy and mucosal resections, such as delayed bleeding or perforation.

Apollo plans to initiate a limited launch with select gastroenterologists beginning January 2021, to be followed by a full launch planned for late in the 1st quarter of 2021.

"The X-Tack System fills a substantial gap in the ability of endoscopists to close full thickness defects, particularly large or irregular colonic and small bowel resection sites. It has the potential for making a significant impact in other procedures as well," said Dr Stavros Stavropoulos, Director of Endoscopy, NYU-Winthrop Hospital. "X-Tack is a highly versatile technology that has the potential to revolutionize our tissue approximation capabilities during endoscopic surgery. I am looking forward to exploring the diverse applications of this technology and the possible benefits to our patients."

Approximately 20 million endoscopic procedures are performed in the United States 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. As the complexity of polyp removal sites expand, endoscopy societies are recommending preventative closure of removal sites to decrease the patient risk of delayed bleeding, especially in the large number of colonoscopy patients who are taking blood thinning medications.