InnoCare Urologics has recently announced the achievement of receiving 510(k) clearance from the FDA for its innovative urinary safety catheter. This milestone allows the Miami-based organization to be the first to obtain FDA approval under a new classification that recognizes urinary catheters equipped with enhanced safety features.
The company’s latest advancement, the Egress safety catheter, has been engineered to prevent injuries typically caused by the accidental removal of traditional indwelling catheters with inflated balloons. Thanks to InnoCare’s unique technology, the catheter balloon automatically deflates before an unintended removal, significantly reducing patient harm risks.
According to their press statement, medical professionals can effortlessly incorporate the Egress system into their workflows without requiring extra supplies or adjustments. Dr. Bruce Gardner, from Sanford Health, highlighted that traditional catheters being pulled out can often result in severe bleeding, prolonged catheter usage, and potentially necessitate surgical intervention. Describing Egress as a “safer alternative,” Gardner noted its particular importance for ICU patients and those diagnosed with delirium or dementia.
“Identifying a clear necessity, we opted to innovate a catheter design, untouched by substantial advancements since its inception over eight decades ago,” expressed Bryan Pinchuk, the CEO and founder of InnoCare Urologics. “The introduction of this new classification affirms the need for safer substitutes to conventional Foley catheters. We look forward to making this technology accessible to numerous high-risk patients, and this approval marks an essential progression toward that vision.”