the U.S. Food and Drug Administration (FDA) 510(k) clearance of the endomina® system, designed for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract on adult
The endomina system is comprised of a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES). It can be affixed to various tested standard endoscopes, providing a bendable therapeutic channel that can move independently. This degree of freedom enables the gastroenterologist to perform endoscopic suturing similar to laparoscopy interventions but using only a natural orifice (mouth), providing an incisionless procedure.
“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” said Dr Ivo Boškoski from Policlinico Gemelli, Rome, Italy. “The endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients.”
The endomina system is CE marked and commercially available outside the United States. In addition, the system is in European clinical studies for a wide range of procedures in the digestive tract such as bariatric interventions, Gastroesophageal Reflux Disease (GERD) or Endoscopic Full Thickness Resection (EFTR).
“We are delighted to bring this innovative and disruptive technology to the U.S. market,” said Alexandre Chau, chief executive office, Endo Tools Therapeutics. “Developed with physician needs in mind, the endomina system was designed to enable physicians to perform endoscopic suturing similar to laparoscopic procedures, but without an incision.”
The company plans to have a limited market release of the endomina system in the U.S. in the first half of 2022, followed by a larger market release later in the year. “We are very excited to soon have the endomina system as part of our portfolio so we can continue to offer less invasive, cutting-edge technologies to treat our patients,” said Dr. Shelby Sullivan, University of Colorado Medicine in Denver, Colorado.