Miami, FL -- InnoCare Urologics announced today that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The EgressTM Safety Catheter eliminates the injuries that occur when traditional indwelling catheters are pulled out while the catheter balloon is still inflated. InnoCare’s proprietary technology enables the catheter balloon to automatically deflate before a pullout occurs, avoiding extensive patient harm. Clinicians can seamlessly integrate the EgressTM catheter into clinical practice without additional supplies or preparation.
“A pulled-out catheter has typically led to significant bleeding, extended catheterization time, and reparation surgery, requiring diversion of resources and longer hospital stays for an already impacted patient population,” said Dr. Bruce Gardner, radiologist at Sanford Health. “The EgressTM catheter is a safer alternative, particularly among patients in the ICU and those with delirium or dementia who are at the highest risk of pulling out their catheters.”
“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.”
The Foley catheter is one of the most widely used medical devices, with over 30 million prescribed in the U.S. alone each year. InnoCare will be evaluating the catheter in select hospitals and in parallel is exploring strategic commercial partnership opportunities.
For more information about InnoCare Urologics, visit www.innocareurologics.com.
InnoCare Urologics, LLC is a privately held medical device company headquartered in Miami, FL. The Company is developing a suite of proprietary indwelling urinary safety catheters focused on improving patient outcomes and reducing healthcare costs.