MOTUS GI, a medical device company dedicated to improving colonoscopy outcomes and experiences, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Pure-Vu System.
The Pure-Vu System works with standard colonoscopes to cleanse poorly prepped colons during the colonoscopy procedure, reducing the sole dependency on pre-procedural prep regimes to reliably and consistently obtain clear visualization of the colon wall.
"Colonoscopy prep can be unpleasant for patients and can impact compliance to the prescribed prep regimens," said Dr. Steven Edmundowicz, medical director of the University of Colorado Digestive Health Center.
"A significant percentage of all patients undergoing a colonoscopy are inadequately prepped, which leads to issues in obtaining clear visualization and an accurate diagnosis for the patient. Poorly prepped colons can lead to prolonged procedure times, missed adenomas and cancers, repeat exams and reduced patient satisfaction."
Pure-Vu uses a mixture of water and air to loosen debris from the colon mucosa while simultaneously evacuating the bowel contents, clearing the way for the endoscopist to perform a high-quality examination — even when the patient did not complete a successful prep on his or her own.
The Pure-Vu System consists of a disposable component and a workstation controller. The disposable fits over standard colonoscopes without interfering with the working channel, allowing the physician to intra-procedurally clean and then visualize, diagnose and, if necessary, treat the colon in a standard fashion.
"One of the greatest challenges with colonoscopies is that the procedure often has to be repeated earlier than recommended guidelines due to an inadequate preparation that can obstruct the visualization of polyps or other anomalies in the colon," said Mark Pomeranz, CEO of MOTUS GI.
"With FDA clearance of Pure-Vu, we can now provide physicians with more flexibility in treating their patients, while addressing issues such as early repeat procedures, missed adenomas, reduced patient satisfaction and higher costs that are associated with poorly prepared colons. In the coming months we will move forward with our pilot commercial launch of the Pure-Vu System focusing on both the in-hospital and outpatient settings."