The endomina system is developed for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract on adult population

Endo

The endomina system for gastroenterologists. (Credit: PRNewswire / Endo Tools Therapeutics)

Endo Tools Therapeutics (ETT) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new suturing tool endomina system.

The company has designed the endomina system for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract on adult population.

Designed for gastroenterologists, the new suturing tool features a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES).

The endomina system allows affixation to different tested standard endoscopes to serve as a bendable therapeutic channel for independent movement.

It will enable gastroenterologist to carry out endoscopic suturing similar to laparoscopy interventions but using only natural orifice (mouth), thereby helping to use an incisionless procedure.

Endo Tools Therapeutics CEO Alexandre Chau said: “We are delighted to bring this innovative and disruptive technology to the U.S. market.

“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.” 

In the first half of this year, the company is planning a limited market release of the endomina system in the US. Later, the system will be release on a larger basis.

The endomina system is also CE marked and commercially sold outside the US, said the company.

The firm is also assessing the system in European clinical studies for use in a range of procedures in the digestive tract such as bariatric interventions, gastroesophageal reflux disease (GERD) or endoscopic full thickness resection (EFTR).