2023-05-17 10:02:01 ET
- Motus GI initiates clinical evaluation of the Pure-Vu Gen 4 Gastro device in collaboration with the Ecuadorian Institute of Digestive Diseases (IECED) to address high unmet patient need in upper gastrointestinal ( GI ) bleeding procedures.
- The company plans to submit a marketing ap application to the U.S. FDA for the Pure-Vu Gastro device in Q4 2023, targeting the market of 400,000 upper GI bleeds and impaired visualization procedures in the U.S.
- Initial clinical evaluation shows high usability scores and efficiency in navigating and evaluating the upper GI tract, with procedures averaging only 11 minutes.
- Further evaluations will explore the device's application in critical indications like upper GI bleeding and new therapeutic approaches such as underwater endoscopic mucosal resection.
- Pure-Vu Gen 4 Gastro utilizes pulsed vortex irrigation and suction technology to target blood and blood clots in the upper GI tract, improving visualization for physicians.
- Motus GI aims to enhance visualization in both upper and lower GI tracts with the Gen 4 technology, using the same workstation for the Pure-Vu Gen 4 Gastro and Colon devices.
- Upper GI bleeds affect approximately 400,000 cases per year in the U.S., and removing adherent blood clots is crucial for identifying and treating the bleed source.
- Press Release
For further details see:
Motus GI's Pure-Vu Gen 4 Gastro device shows promising Results in clinical evaluation for upper GI bleeding procedures