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Ingenion Medical Obtains CE Mark for Catheter

May 2, 2024

Ingenion Medical has announced the receipt of a CE mark for its cymactive catheter.

The company said the device has been designed as an improved alternative to Foley and intermittent-type catheters.

Approved to remain securely in place for up to 30 days, the catheter uses a four-winged flange called a Malecot anchor in the bladder, with drainage at the base to allow patients to have a complete void while urinating.

With the Malecot anchor locked in place in a patient’s bladder, a patient’s urethra seals over the device’s input tube. Once installed, patients are provided with a magnet to control the movement of a metal ball within the device, which is used to block or open its valve in order to simulate the feeling of ‘normal’ urination.

Professor Kurt Naber, an expert in urinary tract infections based at the Department of Urology, Technical University of Munich, said: “I believe that the cymactive device has the potential to help urologists, urology nurses and indeed, entire health and social care systems, make a real difference to combatting catheter-associated urinary tract infection (CaUTIs), and thereby reduce antibiotic use.

“We urgently need novel approaches like this to manage the burden of anti-microbial resistance, which is an unfortunate complication of all medical practice today, and a looming threat to humanity.”

Since being founded in 2013, Ingenion has raised around £5m in capital. In 2020, the company received £100,000 in funding from innovation agency Innovate UK in pursuit of obtaining the CE mark for its catheter.

Commenting on its future plans, Ingenion Medical’s chairman Dr Sergio Rothstein said: “We are planning to take our core, patented valve technology into multiple use cases, including solutions for women’s incontinence and retention.

“Therefore, cymactive is the first of a pipeline of world-class, disruptive urology solutions from Ingenion.”

US-based nanoscience company EVŌQ Nano’s antimicrobial medical device platform recently demonstrated effectiveness against the world’s leading pathogens implicated in healthcare-associated infections (HAIs).

Extensive lab tests, conducted in collaboration with leading catheter manufacturers, revealed that catheters embedded with EVŌQ Nano’s EVQ-218 nanoparticle demonstrated a strong antibacterial, antifungal, and antibiofilm efficacy, including a 7-8 log reduction in Staphylococcus aureus.

Medical device giant Johnson & Johnson (J&J) recently launched its Cereglide aspiration catheter in Europe, the Middle East, Africa (EMEA).