Press release

Safe Medical’s Signal Catheter®, the First Foley Catheter Technology to Address Accidental Inflation in the Urethra, Demonstrates Superior Results Compared to Market Leading Catheter

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Safe Medical Design, a company focused on reducing complications caused by the use of urethral catheters, recently published data demonstrating the effectiveness of their Signal Catheter® in reducing intraurethral pressure and limiting balloon diameter that leads to urethral trauma when the catheter is inadvertently inflated in the urethra during placement.

30 million Foley catheters are placed annually in the United States. Accidental balloon inflation in the urethra during catheterization is a leading cause of non-infectious Foley catheter complications. The Signal Catheter® is the first Foley catheter technology that eliminates the risk of accidental balloon inflation without the need for any additional equipment or change to catheter placement technique. A 2018 study in JAMA Internal Medicine found that non-infectious complications are 5 times more common than Catheter Associated Urinary Tract Infection (CAUTI). Accidental Balloon Inflation in the urethra results in nearly $1B in unnecessary healthcare costs annually.

The Signal Catheter® utilizes a proprietary “Signal Balloon” that limits urethral pressure to a safe level reducing the risk of urethral trauma while providing a visual indicator to the user if the Foley balloon is inadvertently inflated in the urethra.

A recent study in freshly explanted human urethras compared the Signal Catheter® to a market leading BARD Foley catheter. The Signal Catheter® had five times lower intraurethral pressure and a 60% reduction in balloon diameter when inflated in the urethra when compared to the market leading Foley catheter.

“These results confirm that the Signal Catheter® effectively limits urethral pressure below the commonly accepted trauma threshold during accidental urethral inflation. Trauma from urethral inflation is a leading cause of unnecessary complications and cost in the healthcare system. We are excited about the level of clinical interest in the product as we begin our pilot program,” said Cedar Sanai urologist and CMO Dr. Maurice Garcia.

The FDA cleared Signal Catheter® is now available in the U.S. in both individual and kitted configurations.