COLUMBUS, Ohio—PercuVision®LLC, announced today that it received FDA clearance to market the DirectVision™ System, a new medical device that lets nursessee,in real-time,the inside of the urethra whenplacing urinary catheters.
The innovation, according to Errol Singh,MD, F.A.C.S.,a practicing urologist,inventor and CEO of PercuVision®,is introducing vision toa procedurethat is done blindly. “The problem with a blind insertionis that a nursedoesnot knowthe location of the catheter or what is preventing the catheter from advancing.The nurse is reallydriving blindly; guessingwhether to pushthe catheterforward or manipulateit to get around a point of resistance. Risk of injury increases the more the catheter is manipulated. By the time I am called, damage to the urethra is usually already done. Using
DirectVision™,you see what is ahead. You know when to push, when to turn,and in which direction."Direct visualizationin medical procedures is catching on. According to the National Quality Forum Safe Practices, strategies for progressive organizations include “direct visualization of the urethra during insertion of catheters, with the recognition that damage to the urethra can occur with blind insertion, leading to risk of infection."
The Center for Disease Control and Prevention (CDC) reports that onein fourpatientshospitalized in the United Statesiscatheterizedto void the bladder or monitor urinary output during surgery.In the male population, Singh estimates that about 20% of catheterizations are difficult.“I am just delighted with FDA clearance,”says Singh. “We are now getting ready for market launch."