As European regulators tighten restrictions on PFAS, BioInteractions already offers a proven, higher-performing alternative for medical technology
The pressure on medical device manufacturers to eliminate per- and polyfluoroalkyl substances (PFAS) from their products is intensifying. Driven primarily by regulatory momentum in Europe – where the European Chemicals Agency (ECHA) has advanced a landmark universal restriction proposal that would apply to thousands of PFAS compounds – the industry is entering a period of enforced transition. For many device manufacturers, the challenge is significant: PFAS have been embedded in medical technology for decades, prized for their chemical stability, thermal resistance and, above all, their lubricity.
Nowhere is this more apparent than in catheter technology. Polytetrafluoroethylene (PTFE) – a PFAS – is widely used as an internal liner in PEBAX catheters, providing the low-friction surface that allows guidewires and devices to navigate through the catheter lumen. It is functional, well-understood, and, until recently, largely unquestioned. But as the regulatory landscape shifts, manufacturers that have built their products around PTFE liners now face a fundamental question: what replaces it, and can that replacement match or exceed the performance they depend on?
The BioInteractions solution: Assist™
At BioInteractions, we have a clear answer. As a UK-based medical device coatings specialist, we have been PFAS-free across our entire product portfolio since our inception – a position that now places us ahead of an industry curve that is only beginning to steepen.
Assist™ is our Durable Hydrophilic Surface-Active Material: a flexible, single-layer coating designed specifically to reduce friction and minimise unwanted interactions on medical device surfaces. Available in UV and heat-cured variants, it can be applied across a wide range of substrates and geometries, from small implants with tolerances of less than five microns to large systems exceeding 20m in length. Critically, Assist™ has been in clinical use for over 25 years and is deployed on FDA-approved and CE-approved devices without rejection or recall. It is tested to ISO 10993 biocompatibility standards.
The application we are actively targeting is the replacement of PTFE liners on the internal lumens of PEBAX catheters. Coating the inside of tubes is not new to us: we have been doing it for more than 30 years. Our Astute® antithrombogenic coating, for example, is applied to haemodialysis catheters on both their inner and outer surfaces, demonstrating our established capability in internal lumen and external surface catheter coating applications.
Enhanced performance and safety: The key benefits of Assist™
The performance case for Assist™ in this application is compelling on two fronts. The first is lubricity. Independent third-party testing conducted by an independent testing service produced a coefficient of friction of 0.009 for Assist™-coated PEBAX. PTFE, widely cited as the benchmark for low-friction materials, has a dynamic coefficient of friction of between 0.04 and 0.08. Our result on substrates such as 65D PEBAX has produced a coefficient as low as 0.002. The second front is particulation. PTFE liner shedding is a known clinical concern; Assist™ is engineered specifically to produce negligible particulates, and this has been independently validated.
Beyond lubricity and particulation, Assist™ bonds directly to PEBAX without risk of delamination – a critical property in an internal liner application, where coating integrity under repeated mechanical stress is non-negotiable. The coating is surface-bound, even under tortuous conditions, and provides permanent efficacy, consistent with our broader Surface-Active Systems platform.
The regulatory and commercial logic is clear. Europe’s PFAS restriction trajectory is set, and manufacturers that wait for formal prohibition before acting risk disruption to supply chains, regulatory submissions, and product roadmaps. The window to evaluate, validate, and transition coating solutions is now. We offer OEM partners a PFAS-free, biocompatibility-tested solution that does not require compromise on the performance properties that make PTFE attractive in the first place – backed by more than three decades of applied coating expertise.
Please Note: This is a Commercial Profile
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