InnoCare Urologics Receives 510(k) Clearance for Its Novel Urinary Safety Catheter
FDA Grants First-Ever Clearance Under New Code for Urinary Catheters with Safety Features
Miami, FL — InnoCare Urologics announced today that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The Egress 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 Egress 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. The Egress 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." — Dr. Bruce Gardner, Radiologist at Sanford Health
"We saw a clear need to innovate a catheter design that has seen minimal advancement since its introduction over 80 years ago. The creation of this new classification code validates the need for a new standard of care beyond 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." — Bryan Pinchuk, CEO and Founder of InnoCare Urologics
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.
About InnoCare Urologics, LLC
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.