By Sean Fenske, Editor-in-Chief

Fluoropolymers such as PTFE have long been valued in medical device design for their lubricity, chemical resistance, and reliability. However, increasing regulatory scrutiny around per- and polyfluoroalkyl substances (PFAS) has prompted device makers to explore new material options that can deliver similar performance while reducing long-term regulatory uncertainty.

Zeus, a longtime supplier of advanced polymer tubing and catheter components to medical device manufacturers, recently introduced its PFX™ platform—an expanding portfolio of non-fluorinated polymer solutions designed to meet the performance demands of modern catheter design.

In the following Q&A, Zeus Chief Technology Officer Suresh Sainath discusses the thinking behind the platform, the first product to launch from it, and what’s ahead.

Sean Fenske: You’ve recently announced a new platform called PFX™. Can you provide a brief overview of what makes it unique?

Suresh Sainath: What makes the PFX™ platform different is that it’s not just a one-off product launch or new material; it represents an entirely new chapter in catheter design. With this platform, we’re bringing together a whole portfolio of non-fluorinated polymer solutions that deliver the performance R&D engineers expect and rely on, while simultaneously opening new possibilities in catheter design and manufacturing. At its core, the platform is about helping OEMs move forward with confidence as the industry begins to look beyond PFAS.

Fenske: The first product is PFX Flex™. What is this product, where is it used, and what physical characteristics does it offer?

Sainath: The first product from the PFX portfolio is PFX Flex™ Sub-Lite-Wall™, a next-generation catheter liner engineered as an alternative to film-cast PTFE that delivers proven lubricity, enhanced bond strength, and expanded sterilization options—all without PFAS.

More specifically, PFX Flex liners are made from a non-fluorinated polymer resin and are produced without the intentional use of any per- or polyfluoroalkyl substances (PFAS). To validate this, we sent representative samples to an independent third-party laboratory for evaluation, which confirmed total fluorine levels below 20 ppm. In short, these liners provide the performance engineers expect without relying on fluorinated polymer chemistry.

Beyond material composition, sizing is another major differentiator between PTFE and PFX Flex liners. Today, film-cast PTFE liners are limited in the size of the inner diameter due to the manufacturing process. However, with the proprietary film-cast process we developed for PFX Flex, we can produce liners with IDs up to 0.387″—at least three times larger than what’s typically available in film-cast PTFE.

So, with this broad ID range from 0.013″ to 0.387″ and nominal wall thicknesses as low as 0.0015″, we expect PFX Flex liners to support a wide variety of applications, from neurovascular procedures to structural heart therapies.

Fenske: How does PFX Flex compare with regard to lubricity, flexibility, and other attributes often associated with PTFE?

Sainath: From the beginning, we knew lubricity would be one of the first questions engineers would ask. Whenever you position something as a PTFE alternative, engineers will automatically compare it directly to PTFE’s lubricity, which is the standard. As outlined in our test report, Comparing PFX Flex vs. PTFE Catheter Liners, in our testing, we saw that PFX Flex is indeed an extremely lubricious material, with a coefficient of friction of around 0.1 at 23°C in air and less than 0.1 at body temperature in saline.

To put that in perspective, a COF at or below 0.1 puts you squarely in PTFE territory from a lubricity perspective. And unlike many other non-fluorinated options on the market, PFX Flex achieves that kind of performance without additives or surface coatings. The performance is inherent to the material itself.

Flexibility was another trait we knew engineers would be highly interested in. In the same test report, we share results from tip deflection testing on catheter shafts built with PFX Flex Sub-Lite-Wall™, free-extruded PTFE Sub-Lite-Wall™, and film-cast PTFE StreamLiner™ NG liners. Shafts lined with free-extruded PTFE were about 20% stiffer than those lined with PFX Flex, while PFX Flex matched the flexibility of film-cast PTFE StreamLiner NG. In other words, we saw PTFE-like flexibility, and in some cases, even an improvement.

Finally, another differentiator worth mentioning is bondability. Traditional PTFE requires chemical etching before it can bond to other materials. PFX Flex doesn’t. It forms direct covalent bonds to jacketing materials, which helps create durable, delamination-resistant assemblies without the added processing step. For many engineers, that improved bond strength and simplified manufacturing process could open the door to new catheter design possibilities.

Fenske: You mentioned PFX Flex also offers some flexibility in the sterilization process. What methods can be used for this product?

Sainath: One of the well-known challenges with PTFE is its susceptibility to radiation-induced degradation. As a result, PTFE-based devices are typically limited to ethylene oxide (EtO) sterilization. PFX Flex, however, does not possess this same limitation.

As detailed in our test report, we found that catheter shafts lined with PFX Flex maintained their performance after sterilization with EtO, gamma, and e-beam. That broader compatibility can give OEMs more flexibility in how they approach sterilization, whether they’re looking to diversify their sterilization strategy, streamline operations, or align with evolving sustainability goals. It opens up more options rather than limiting them to a single pathway.

Fenske: As PFX is a platform, what’s ahead for this offering? What can we look forward to?

Sainath: While PFX Flex is the first product to launch, it’s really just the beginning. We already have additional solutions on the roadmap.

PFX Max™ is an upcoming liner designed to be an alternative to free-extruded PTFE and to deliver greater strength, thinner walls, and tighter tolerances for more advanced catheter applications. We’re also developing PFX Peelz™, a peelable heat-shrink alternative to FEP aimed at improving manufacturing efficiency while supporting higher waste-to-energy recovery. And another exciting product in development is PFX Glide™, a next-generation alternative to polyimides with lubricious additives, engineered to provide low friction, strong dielectric performance, and excellent wear resistance.

What excites us most is that PFX creates room for progress. It empowers catheter device makers to think differently about materials, design freedom, and long-term sustainability without sacrificing the performance standards they depend on. In many ways, this is just the starting point for a broader transformation in catheter design and manufacturing.

Additional information about Zeus and the PFX platform is available at: Zeusinc.com/PFX-Flex