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Endomina suturing tool wins FDA clearance

January 18, 2022 By Danielle Kirsh

endo-tools-therapeuticsEndo 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.

Filed Under: Endoscopes Tagged With: Endo Tools Therapeutics

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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