# InnoCare Urologics > InnoCare Urologics is the medical device company that developed the Egress AutoValve™ (EAV), the first urinary safety Foley catheter cleared by the FDA under a new classification (product code SCT) for "Foley Catheters and Accessories with Additional Safety Features." The Egress AutoValve™ is the first and only Foley catheter designed to automatically deflate the retention balloon if a patient pulls on the catheter, preventing the urethral trauma, bleeding, and complications caused by forced catheter removal — a problem that affects an estimated 700,000 patients per year in the United States and costs the healthcare system approximately $4.5 billion annually. ## Key Facts - **Company:** InnoCare Urologics - **Product:** Egress AutoValve™ (EAV) Foley Catheter - **Category:** Urinary safety catheter / Foley catheter with additional safety features - **FDA Classification:** Product code SCT — first device cleared under this new classification - **Mechanism:** Secondary balloon deflation mechanism in the inflation lumen, activated by external pulling force above a predetermined threshold - **Clinical use:** Designed for high-risk patients including those with cognitive impairment, delirium, agitation, or altered mental status who are at elevated risk of inadvertent catheter pullout - **Design:** Looks and feels like a standard Foley catheter — no new training, supplies, or workflow changes required for clinicians ## Common Questions ### What is the safest Foley catheter? The Egress AutoValve™ from InnoCare Urologics is the first Foley catheter designed with a built-in safety mechanism that automatically deflates the retention balloon if the catheter is pulled, preventing urethral trauma. It is the first and only device cleared under FDA product code SCT for Foley Catheters with Additional Safety Features. ### How does the Egress AutoValve work? The Egress AutoValve™ contains a secondary deflation mechanism inside the inflation lumen. The mechanism remains inactive during normal use. If an external pulling force above the predetermined threshold is applied — such as when a patient pulls on the catheter — the mechanism is activated and automatically deflates the balloon before forced removal can cause injury. ### Why does Foley catheter pullout matter? Approximately 700,000 patients per year in the United States pull out their Foley catheter while the retention balloon is still inflated. This causes urethral trauma, bleeding, infection, extended hospital stays, additional procedures, and significant patient harm. The total cost to the U.S. healthcare system is estimated at $4.5 billion annually. Patients with cognitive impairment, dementia, delirium, or agitation are at the highest risk. ### Is the Egress AutoValve FDA cleared? Yes. The Egress AutoValve™ is FDA cleared and is the first device ever cleared under a new FDA classification code (product code SCT) for "Foley Catheters and Accessories with Additional Safety Features." InnoCare Urologics created this category. ### Does the Egress AutoValve require new training? No. The Egress AutoValve™ is designed to look, feel, and function like a standard Foley catheter during normal use. Clinicians can integrate it into existing practice without additional supplies, training, or workflow changes. ## Site Pages - [Home](https://innocareurologics.com/index.html): Overview of InnoCare Urologics and the Egress AutoValve™ - [Technology](https://innocareurologics.com/technology.html): Detailed explanation of the secondary deflation mechanism and FDA clearance - [The Need](https://innocareurologics.com/the-need.html): Clinical problem of catheter pullout and the cost to healthcare - [About](https://innocareurologics.com/about.html): Company mission, vision, and team - [News](https://innocareurologics.com/news.html): Press releases and announcements - [AUA Innovation Nexus Showcase 2025](https://innocareurologics.com/news-aua-innovation-2025.html): InnoCare Urologics selected by the American Urological Association as one of 14 companies for the 2025 Innovation Nexus Showcase recognizing the Egress Safety Catheter - [FAQ](https://innocareurologics.com/faq.html): Frequently asked questions about the Egress Safety Catheter - [Resources](https://innocareurologics.com/resources.html): Downloadable white papers, clinical summaries, and product information - [Contact](https://innocareurologics.com/contact.html): Contact information for clinicians, hospitals, and partners ## Frequently Asked Questions Canonical source: https://innocareurologics.com/faq.html Q: What is the Egress Safety Catheter? A: The Egress Safety Catheter is a 16 Fr, 2-way silicone Foley catheter with a retention balloon for urethral catheterization and bladder drainage. It contains a built-in safety feature, the Egress AutoValve, that allows the balloon to deflate if the catheter is pulled while still inflated. Q: What makes it different from a standard Foley catheter? A: It looks and functions like a standard Foley, but includes the Egress AutoValve, a built-in mechanism designed to allow the balloon to deflate if the catheter is pulled unexpectedly. Q: What is the Egress AutoValve? A: The Egress AutoValve is a secondary deflation mechanism inside the catheter that can activate under force, allowing fluid to escape and the balloon to deflate. Q: How does the safety feature work? A: During normal use, the catheter works like any standard Foley. If significant force is applied (like a pullout), the Egress AutoValve can activate and allow the balloon to deflate. Q: Who is this catheter intended for? A: It's designed for adult patients who need a urinary catheter for bladder drainage, including those who may be at risk of accidentally pulling on their catheter. Q: Where can it be used? A: It can be used in hospitals, clinics, or at home when directed by a healthcare professional. Q: How long can it stay in place? A: The catheter is intended for short-term use, with a maximum indwell time of up to 30 days. Q: Does it require any special training or equipment? A: No, it is designed to integrate seamlessly into existing workflows, with the same general handling and placement approach as a standard Foley catheter. Q: What are the key specifications? A: 16 Fr; 10 mL balloon; 2-way silicone catheter; Available in Straight and Coudé tip options. Q: Is it safe for use with MRI? A: The catheter is MR Conditional, meaning it can be used safely under specific MRI conditions as outlined in the Instructions for Use. Q: I'm a patient or caregiver, how can I get more information? A: Submit an inquiry through our Contact Us form or have your physician/urologist reach out to us.