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The endomina system can be affixed to various testing standard endoscopies for a bendable therapeutic channel.
The US Food and Drug Administration (FDA) has cleared the endomina system for endoscopic placement of sutures and approximation of soft tissue in the gastrointestinal tract for adult patients.
The approval allows Endo Tools Therapeutics to move forward with the system comprised of a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES).
The platform can be affixed to various testing standard endoscopes to provide a bendable therapeutic channel that moves independently and enables the clinician to perform endoscopic suturing similar to laparoscopy interventions while using only the mouth to provide an incisionless procedure.
"This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing," said Ivo Boškoski, MD, PhD, Policlinico Gemelli, in a statement. "The endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients."
The system is currently available outside of the US and being considered for a wide range of procedures in the digestive tract, including bariatric interventions, gastroesophageal reflux disease (GERD), and endoscopic full thickness resection (EFTR).
Endo Tools Therapeutics has indicated plans for a limited market release in the US in the first half of 2022, followed by a larger market release later in the year.
"We are delighted to bring this innovative and disruptive technology to the U.S. market," said Alexandre Chau, chief executive office, Endo Tools Therapeutics, in a statement. "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."