InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter.
The Miami-based company says it marks the first-ever FDA clearance under a new code for urinary catheters with safety features.
InnoCare designed its Egress safety catheter to eliminate the injuries that occur when traditional indwelling catheters are pulled out while the catheter balloon is still inflated. The company’s proprietary technology enables the catheter balloon to automatically deflate before a pullout occurs. This helps to avoid extensive patient harm.
According to a news release, clinicians can seamlessly integrate Egress into clinical practice without additional supplies or preparation. Dr. Bruce Gardner, a radiologist at Sanford Health, said a pulled-out catheter can typically lead to significant bleeding, extended catheterization time and reparation surgery. Gardner called Egress a “safer alternative,” especially for patients in the ICU and those with delirium or dementia.
“We saw a clear need to innovate a catheter design that has seen minimal advancement since its introduction over 80 years ago,” said Bryan Pinchuk, CEO and founder of InnoCare Urologics. “The creation of this new classification code validates the need to provide a safer alternative to traditional Foley catheters. We are excited to bring a technology to market for millions of high-risk patients, and this milestone is a critical step in achieving that goal.”
