Pure-Vu GEN2 FDA Cleared to Clean Colons During Colonoscopy Exams
Motus GI, a company now headquartered in Fort Lauderdale, Florida, has won FDA clearance for the latest version of its Pure-Vu colon cleansing system. Designed for use during colonoscopies, the system is designed to clear out debris left in the colon that can hinder proper visualization of potential polyps.
Patients are advised to fast and follow a few guidelines prior to their colonoscopies, but too many fail to do so properly and even those that do are often left with a dirty colon. This can result in unnoticed polyps, cancelled and rescheduled procedures, delayed treatments, and frustrated physicians who are not able to do their jobs.
The Pure-Vu works with existing colonoscopes, including slim ones, to directly wash the colon and evacuate the muck. The latest version of the system, called Pure-Vu GEN2, improves on the original model by being easier to move around and set up, and offering more advanced navigation, while maintaining the cleaning capabilities of the original product.
“Receiving FDA clearance for our Pure-Vu® GEN2 represents a major milestone for the Company,” said Tim Moran, Chief Executive Officer of Motus GI. “The Pure-Vu® System continues to demonstrate outstanding cleansing performance in poorly prepped colons, including a 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.”
Product page: Pure-Vu system…
Via: Motus GI