Sam Brusco, Associate Editor01.18.22
Endo Tool Therapuetics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its endomina system, which endoscopically places sutures and approximates soft tissue in the gastrointestinal tract for adults.
endomina contains a universal triangulation platform and instrument for tissue piercing and approximation (TAPES). It can be attached to many standard endoscopes for a bendable therapeutic channel that can move independently. This lets gastroeneterologists perform endoscopic suturing similar to laparoscopy but using only the mouth, allowing an incisionless procedure.
"This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing," Dr. Ivo Boškoski from Policlinico Gemelli, Rome, Italy told the press. "The endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients."
endomina is CE market and available commercially outside the U.S. It is in European clinical studies for digestive tract procedures including bariatric interventions, gastroesophageal reflux disease (GERD), and endoscopic full thickness resection (EFTR).
"We are delighted to bring this innovative and disruptive technology to the U.S. market," said Endo Tools CEO Alexandre Chau. "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 intends to have a limited endomina market release in the first half of this year, followed by a larger release later this 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, Colo.
endomina contains a universal triangulation platform and instrument for tissue piercing and approximation (TAPES). It can be attached to many standard endoscopes for a bendable therapeutic channel that can move independently. This lets gastroeneterologists perform endoscopic suturing similar to laparoscopy but using only the mouth, allowing an incisionless procedure.
"This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing," Dr. Ivo Boškoski from Policlinico Gemelli, Rome, Italy told the press. "The endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients."
endomina is CE market and available commercially outside the U.S. It is in European clinical studies for digestive tract procedures including bariatric interventions, gastroesophageal reflux disease (GERD), and endoscopic full thickness resection (EFTR).
"We are delighted to bring this innovative and disruptive technology to the U.S. market," said Endo Tools CEO Alexandre Chau. "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 intends to have a limited endomina market release in the first half of this year, followed by a larger release later this 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, Colo.
