Endo Tools Therapeutics today announced that its Endomina suturing tool won FDA 510(k) clearance.

The Belgium-based company designed the system for the endoscopic placement of sutures and approximation of soft tissue in the gastrointestinal tract in adults.

Endomina has a universal triangulation platform and an instrument for tissue piercing and approximation. It can be affixed to various tested standard endoscopes for a bendable therapeutic channel that can move independently, according to the company. It allows gastroenterologists to perform endoscopic suturing similar to laparoscopy interventions using only the mouth for an incision-free procedure.

“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” Dr. Ivo Boškoski, a doctor at Policlinico Gemelli in Rome, Italy, said in a news release. “The Endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients.”

Endomina is currently CE marked and commercially available outside the U.S. The company plans to have a limited market release of the system in the U.S. in the first half of 2022 with a larger market release to follow later in the year.