Positive results for Camstent's CE marked polymer coated catheter

Camstent’s CE marked polymer coated catheter which prevents biofilm attachment, receives positive results for its first in-human pilot study.

UK-based Camstent, which applied proprietary bacteria-phobic polymer coatings to medical devices, has received the initial results from the first in-man pilot study for its CE marked, coated catheter. Camstent believes that the initial results from the first in-human pilot study could pave the way for a novel approach in the fight against super-bugs.

The Camstent coated Foley Catheter is intended for the drainage of urine from the urinary bladder. Camstent claims that the coating enhances lubricity, and thus significantly reduces insertion force.

The results, which compared 10 Camstent coated catheters and 12 uncoated silicone catheters, showed a clear reduction of biofilm formation and biomineralisation on the Camstent polymer coated catheters compared with uncoated catheters. Camstent claims that the results collected are very encouraging for the battle against catheter-associated urinary tract infections.

To support this initial evidence, future comparisons of greater numbers of catheters, the performance of coated catheters over longer time periods and more detailed microbiological investigations will be required.

Catheter-associated urinary tract infection is one the major causes of hospital acquired infections (HAI) and accounts for 38% of all causes. HAI can lead to longer stays in hospitals for patients, can seriously endanger health and lives, and currently costs the NHS one billion pounds every year.

The 22 coated and uncoated samples obtained from patients catheterised for bladder management after urethral reconstructive surgery, were allocated non-randomly. Once removed they were analysed by scientists at centre for biomolecular sciences and school of life sciences, and the school of pharmacy at the University of Nottingham.

The results from the pilot study are being presented this week by clinical researchers from University College London Hospitals NHS Foundation Trust in a poster titled “A new bacterial resistant polymer catheter coating to reduce catheter associated urinary tract infection (CAUTI): A first-in-man pilot study”, at the 34th Annual European Association of Urology Congress in Barcelona and the International Meeting on Reconstructive Urology, Hamburg.

The polymers used in the coating were originally reported to have bacteria-phobic properties and were discovered at the University of Nottingham in 2012. Since then they have been developed by Camstent into a silky-smooth coating for silicone or silicone-based medical devices.

Unlike other coatings that are designed to kill bacteria adhering to the surfaces, Nottingham’s passive non-stick molecule within Camstent’s coating aims to deter bacteria from attaching to the catheter surfaces at all. This novel approach has now been demonstrated to reduce formation of biofilm that, in turn, can lead to infection. It has the added advantage of no potential of creating antibiotic resistant organisms or super-bugs.

Dr Dave Hampton, founder and CTO of Camstent, said: “While our catheter was approved for use in patients last year for its silky-smooth texture, this is the first time we have evidence that our coating acts well in preventing biofilm attachment in humans. These initial results are being corroborated by over 60 cases as we expand the number of settings taking part in trials. We are looking to grow the body of evidence to support these initial results and welcome anyone interested in conducting trials to contact us.”

Daniela Andrich MD MSc FRCS, Honorary Associate Professor, Division of Surgery and Interventional Science, UCL, who has been conducting the pilot study, said: “Our patients are at high risk of post-operative catheter related wound infection and we are very pleased that there is, finally, a non-antibiotic based catheter that aims to protect the patient and has no risk of antibiotic drug resistance. The surface of the catheter is very smooth and hardly requires lubrication for insertion or withdrawal, which is great for the patient. We will continue to evaluate Camstent catheters in our reconstructive urology practice.”