and the company’s chemists have since developed them further, adding agents to make a coating that adheres securely and flexibly to the catheter.

Maintaining flexibility

According to Dr Hampton, the main challenges that needed to be overcome was maintaining flexibility of the coating to assure that it stays in place, enhancing its manufacturability, and assuring that it passed the rigorous requirements for safety, function, and sterilisation requited of hospital-grade products.

“It was crucial to make sure the coating was attached to the catheter surface, without peeling or cracking for the duration of use,” he said. “The balloon, for example, stretches the

surface over 200%, and the coating must stretch with it. Research also suggests that the interior drainage channel for urine, is an important location where bacteria could accumulate, so controlling viscosity to draw the coating material into the catheter during manufacture was important. “The coating material used in Camstent’s products is a single layer of polymer, only 30 microns thick, that can be applied in a single short dip. It is cost-effective to apply, stable on the shelf and in use, and can be applied to many of the materials used in consumable and indwelling medical devices. “The wider intention is to avoid systemic

infections associated with other, frequently used devices, including vaginal pessaries and central venous catheters, which are considered as ‘susceptible biofilms’ for bacterial growth. The coatings are equally suitable for other in-body devices such as stents, shunts and tubes.”

Camstent already holds a CE mark for a ‘silky-smooth’ coated Foley catheter, which has been approved for sale in the UK and EU and is being successfully used in hospitals. The company intends to make further

Rather than trying to kill bacteria once it is already on the catheter, Camstent’s novel approach is to prevent infectious agents from growing on surfaces in the first instance.

MAY 2019

application for approval to bring its ‘bacteria-phobic’ catheter coating to EU / UK and US markets within the next six months once ongoing clinical evaluations are complete and regulatory criteria are met. Dr Hampton asserted: “Millions of urinary catheters are used every day around the world and anybody who has a catheter for longer than a week is likely to get an infection. By simply applying specially coated catheters we believe that we can significantly decrease infection rates, minimise patient stays in hospitals and costs for hospitals. “In the context of antimicrobial resistance, the materials are a major breakthrough. Since nothing is eluted, the coating can’t wear out. The laboratory tests demonstrate that it doesn’t harm the adherent bacteria and that no dead or ruptured cells are accumulated on the catheter surfaces.” Camstent’s current ‘silky-smooth’ coated product has received positive feedback from UK clinicians who highlighted another key benefit for patients – comfort. The low- friction texture of the commercial product makes insertion and removal of the catheter smoother and more comfortable, minimising the need for lubricants. “We demonstrated that the product could be easily inserted and withdrawn, and that it appropriately remained in place and drained the bladder for up to 29 days of patient use, Dr Hampton observed. “Although this wasn’t our initial intention during the R&D stage, it is a tangible benefit for patients that we were excited to offer as our first catheter product. All the clinicians we have spoken to have been extremely pleased about this premium aspect of the product, especially as it comes without a premium cost to hospitals. “We were able to CE mark our first commercial devices on the basis that the coating significantly reduces insertion and withdrawal force while still maintaining performance and safety that hospitals insist on. “Subsequent evaluations and approved pilot studies have subsequently demonstrated


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