FDA OKs Motus GI’s Pure-Vu System for Upper GI Endoscopy

Motus GI Holdings Inc. earned 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for a version of the Pure-Vu System compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to remove blood, blood clots, and debris to provide a clear field-of-view for the endoscopist. This latest innovation for the Pure-Vu System platform integrates with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.
 
“We are pleased to receive FDA clearance for the Pure-Vu System now compatible with gastroscopes for the purpose of providing enhanced visibility during upper GI endoscopies. We believe this regulatory milestone broadens our ability to participate in a larger percentage of procedures performed by our key customers, providing us a natural extension of our commercial strategy. In addition, we have received consistent feedback from leading physicians indicating their view that there is a substantial unmet need in this area, particularly for Upper GI Bleed procedures,” Tim Moran, CEO of Motus GI told the press. “This FDA clearance is a testament to our innovation team’s ability to deliver on customer needs in a timely manner.”
 
Upper GI bleeds occurred in the U.S. at a rate of about 400,000 cases per year in 2019, according to iData Research. The existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. We believe removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10 percent, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).