Motus GI and the Ecuadorian Institute of Digestive Diseases (IECED) have completed the initial clinical assessment of the Pure-Vu Gen 4 Gastro device for upper gastrointestinal (GI) bleeding procedures.
The initial clinical evaluation demonstrated that the Pure-Vu Gen 4 Gastro device significantly navigates and evaluates the upper GI tract. It received high usability scores, ranging from very good to excellent.
The upper GI tract procedures proved highly efficient for first-time users, with an average duration of just 11 minutes.
In the colon, the evaluation demonstrated an improvement in the average Boston Bowel Prep Scale for nine patients from 5.9 to 8.9 using Pure-Vu, with an average procedure time of 24 minutes.
The company is in the process of submitting a 510(k) application to the US Food and Drug Administration for the Pure-Vu Gen 4 Gastro device in the fourth quarter of this year.
Roughly 400,000 upper GI bleed cases were reported in the US in 2019.
Motus GI CEO Mark Pomeranz said: “The focus of these procedures was aimed at evaluating the device’s ability to improve a physician’s visualisation while identifying and treating upper GI bleeds.”
Further assessments of the Pure-Vu Gen 4 system will study its effectiveness in essential areas such as upper GI bleeding and explore novel therapeutic uses, including underwater endoscopic mucosal resection.
The Pure-Vu Gen 4 Gastro takes advantage of the colon device’s successful pulsed vortex irrigation and smart sense suction methods.
This upgraded version includes enhancements to target and address blood and blood clots in the upper GI tract.
Furthermore, the system has undergone additional enhancements to facilitate easy navigation within the GI tract. It also allows the physician to hold the endoscope, thereby minimising any ergonomic challenges typically encountered during the procedure.
The company is deploying the Gen 4 technology to optimise the capabilities of the Pure-Vu device within the colon.
The Pure-Vu Gen 4 Gastro and Colon systems will use the same workstation to enhance visualisation in both the upper and lower GI tract to enable the use of these systems across various indications.