Apollo Endosurgery Inc (NASDAQ:APEN) disclosed that it has received the Food and Drug Administration clearance for the X-Tack Endoscopic HeliX Tacking System.
Wednesday’s news release points out that 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 first quarter of 2021.
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.
The Austin, Texas-based company prides itself on being "a global leader in less invasive medical devices for gastrointestinal and bariatric procedures."
APEN shares gained 19 cents, or 4.9%, to $4.05.
