Motus GI Holdings, a medical technology company focused on colonoscopy devices, announced that US Food and Drug Administration (FDA) has granted 510(k) clearance for its second-generation Pure-Vu System - Pure-Vu GEN2.
According to Motus, which is involved in improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, its Pure-Vu System is a US FDA-cleared medical device designated to help the cleaning of a poorly prepared colon during the colonoscopy procedure.
Pure-Vu GEN2 is compatible for integration with standard and slim colonoscopies to enable safe and rapid cleansing during the procedure while preserving established procedural workflow and techniques.
Motus has designed Pure-Vu GEN2 to improve mobility, setup logistics of the system and enhance navigation through the colon, retaining the same cleansing functionality as the first generation of the Pure-Vu System.
Motus GI chief executive officer Tim Moran said: “Receiving FDA clearance for our Pure-Vu GEN2 represents a major milestone for the Company. The Pure-Vu System continues to demonstrate outstanding cleansing performance in poorly prepped colons, including the statistically significant improvement in colon cleanliness in hospitalized patients as recently demonstrated by the positive outcome of our REDUCE study.
“With our robust portfolio of health economic and clinical data coupled with 510(k) clearance from the FDA of Pure-Vu GEN2, we are now well positioned to execute our planned commercial launch of the Pure-Vu System this year and advance toward our goal of establishing the Pure-Vu System as a new standard of care in key endoscopy segments.”
With the initial launch, the company plans to focus on the inpatient colonoscopy market where challenges with insufficient bowel prep results in slow diagnosis, diminish the quality of care, and add significant costs to hospital systems.
Motus GI said that its Pure-Vu System is expected to improve quality of care and reduce healthcare costs by moving patients through the hospital system to a successful examination.
University of California Irvine’s division of gastroenterology school of medicine associate clinical professor of medicine Jason B. Samarasena said: “Inadequate bowel preparation prior to colonoscopy remains an unmet need that affects a significant percentage of patients’ ability to receive a complete and high-quality exam.
“This often leads to canceled, delayed and aborted procedures, resulting in prolonged hospitalizations and increased costs for both patients and providers. The Pure-Vu System provides an important solution to address the significant clinical challenges and inefficiencies associated with inadequate prep and the Pure-Vu GEN2 provides an innovative, easy to use platform that enables a streamlined approach to the overall procedure.”