Electrophysiology (EP) Catheters: Evolving Trends and Innovations

Chapters:

00:00 Welcome and Introduction
00:29 Session Overview
01:02 Introducing the Experts
02:08 Sponsor Highlights
04:26 Discussion with Joe Keyes: Electrophysiology Trends
07:46 Understanding Cardiac Ablation
09:01 Pulsed Field Ablation Explained
12:41 Animation Walkthrough
14:46 Miniaturization in EP Technology
17:46 Mapping and Ablation Catheters
19:50 Robotics in EP Labs
20:57 Portable EP Systems
21:09 The Role of Nitinol in Modern EP Catheters
23:55 Steerability and Flexibility in EP Procedures
26:14 Designing Safe and Effective EP Catheters
28:15 Challenges and Innovations in EP Technology
29:40 The Versatility of Nitinol in Medical Devices
33:07 Shape Memory and Superelasticity
37:07 Localized Mechanical Properties
38:47 Balloons and Hybrid Designs
40:01 Lighteum Medical’s Role in EP Innovation
41:22 Upcoming Events and Closing Remarks

00:00 Welcome and Introduction

Steve Maxson:

Hello everyone and welcome to the Chamfr webinar series. Today’s session is focused on electrophysiology catheters, evolving trends and innovations. I’m Steve Maxson, VP of Growth at Chamfr, and I’ll be moderating this session today.

This webinar is proudly sponsored by Lighteum Medical, Polyzen, and TT Electronics. More on them later.

00:29 Session Overview

Steve Maxson:

Let’s go into some quick housekeeping. First, this session is being recorded. The replay will go out to everyone shortly after we finish.

You will be muted and the chat will be off, but please drop your questions in the Q&A.

One note — Joe Keyes, our featured guest, has a time constraint today, so the live Q&A will be a bit shorter than usual. We’ll answer as many as we can and follow up on the rest via email. Thank you for understanding.

01:02 Introducing the Experts

Steve Maxson:

We’re very excited to feature two outstanding experts.

First up, Joe Keyes, Associate Senior R&D Fellow at Boston Scientific. Joe specializes in EP catheters, PFA, ablation force contact sensing technologies, and advanced catheter designs for treating cardiac arrhythmias.

He’s a true innovator with multiple patents in imaging and sensing, plus deep research in lesion formation and safety.

Next, we’ll hear from Jose Maeso. Jose is the Chief Technology Officer at Lighteum Medical. With over 15 years of experience across major medical OEMs, Jose brings expertise in nitinol process development, femtosecond laser processing, heat shaping, electropolishing, and high-complexity nitinol components driving next-generation EP and PFA ablation technologies.

02:08 Sponsor Highlights

Steve Maxson:

Before we dig into the discussion, I’d like to highlight our promotional sponsors and how they’re promoting innovation in areas like EP catheters.

Starting with Lighteum Medical, a global leader in precious metals and nitinol technologies. They provide nitinol tubing and sheets essential for critical PFA catheter development, plus radiopaque platinum alloy marker bands available right on Chamfr.

Lighteum supports MedTech OEMs from rapid prototyping to high-volume production across four global sites with capabilities in Swiss machining, femtosecond laser cutting, and electropolishing.

Shop over 80 in-stock SKUs on Chamfr featuring superelastic nitinol tubing, nitinol sheets, and marker bands. Scan the QR code to learn more.

Next up, Polyzen. Polyzen is located in my home state of North Carolina and is a leader in the manufacturing of custom polymer-based materials, films, laminates, compliant balloons, components, and assemblies for the medical device industry.

I’ve been to their facility — it’s a beautiful facility. Their material and processing technologies deliver optimal solutions for innovators, from startups to major medical manufacturers, covering everything from prototype development to full-scale production.

Next up, TT Electronics — engineering and manufacturing solutions that enable healthcare innovation. Their products include electromagnetic tracking sensors for precision surgical procedures and miniature implantable devices. They offer full support from design and engineering through NPI to volume manufacturing.

They are ISO 13485 certified and operate in cleanrooms. Check them out on Chamfr as well.

Thanks again to the sponsors for making this episode possible. Their technologies are directly tied to the trends we will discuss today.

04:26 Discussion with Joe Keyes: Electrophysiology Trends

Steve Maxson:

Let’s get started with Joe Keyes. Joe, thanks for joining the Chamfr webinar. It’s great to have you on. I know you have a busy schedule, so we’ll get right into it.

You’ve been in this space for a while and seen a lot of growth. Can you describe the growth and what some of the main drivers are?

Joe Keyes:

I love being in EP. The growth is one thing, but the technology is really what I enjoy.

You could Google what’s going on in EP, but ultimately it comes down to an aging population and a lot more awareness of what AFib is.

Twenty years ago, people thought, “My heart’s beating fast. It’s uncomfortable, but I’ll live with it.” Now there’s much greater awareness and better treatment options.

There’s also been a huge improvement in ablation technology so patients don’t have to rely solely on drugs that make them feel tired and weak.

It’s a combination of natural demographic progression and rapid technological acceleration, along with increased awareness of the disease and what can be done if you have it.

07:46 Understanding Cardiac Ablation

Steve Maxson:

For those who may not be familiar with cardiac procedures, can you describe what cardiac ablation is at a high level — how it brings someone’s heart back to normal rhythm?

Joe Keyes:

At a very simple level, the heart is an electromechanical pump. You put electrical energy in and you get mechanical motion out.

In cardiac electrophysiology, physicians identify abnormal electrical pathways — what you might call bad wiring — that disrupt the normal rhythm of the heart.

Once they find those bad pathways, they apply energy to eliminate them.

Traditionally, the largest modalities used in ablation are:

  • RF ablation, which uses heat
  • Cryoablation, which uses freezing

09:01 Pulsed Field Ablation Explained

Joe Keyes:

The newest modality that’s been coming up is pulsed field ablation. It applies very high-voltage, short-duration pulses to force pores in the cells to open up. That ultimately causes the cells to die, but it does so through a non-thermal mechanism.

Any time you put energy in, you’ll generate some heat — that’s just physics — but heat isn’t the primary mechanism of action.

Originally it was called irreversible electroporation, but the more accurate term is pulsed field ablation.

Steve Maxson:

Does that reduce the potential for damaging the esophagus or nearby nerves?

Joe Keyes:

Yes, that’s part of the big advantage. It doesn’t produce as much heat, so you’re not dumping heat into areas you’re not supposed to.

There’s also thought that it has some degree of cell selectivity. It may preferentially damage cardiomyocytes — heart muscle cells — over surrounding structures like the phrenic nerve.

It opens up the therapeutic window. Physicians don’t need the same level of thermal monitoring. You still need good positioning and contact, but the safety margin is improved for the majority of procedures.

Steve Maxson:

Boston Scientific recently had Farapulse labeled for additional procedures like pulmonary vein isolation and posterior wall ablation. Can you talk about that?

Joe Keyes:

The original intention of Farapulse, even when it was a startup, was pulmonary vein isolation.

In most EP procedures, physicians assess how far along the patient’s progression is and what their symptoms are. The majority of patients undergo pulmonary vein isolation. Physicians target the area around the pulmonary veins, which is a very common trigger point for AFib.

An advantage of Farawave and some other focal platforms is that they make accessing the posterior wall easier. There’s a subset of physicians who isolate the posterior wall as part of their standard clinical practice along with the pulmonary veins.

12:41 Animation Walkthrough

Steve Maxson:

There’s an animation on the website. Can you walk us through what we’re seeing?

Joe Keyes:

Sure. The sheath is what physicians use to gain access to the heart. In this case, they cross from the right atrium into the left atrium.

They use a guidewire to ensure they’re coaxial with the pulmonary vein.

With Farawave, the typical procedure is to position the catheter in the pulmonary vein, ablate, rotate, and ablate again.

Then they change the configuration to what’s called the flower form to ablate the antral region and ensure good coverage. They repeat this for each pulmonary vein.

You can also see the generator interface showing energy delivery. The animation illustrates how cardiomyocytes are preferentially targeted while surrounding tissue is preserved.

14:46 Miniaturization in EP Technology

Steve Maxson:

There’s constant discussion about miniaturization in MedTech — lower profiles, more packed into smaller devices. How important is that in EP?

Joe Keyes:

My old boss used to say if we could design catheters for elephants, it would be easy. That’s accurate.

EP combines physics, biology, electrical engineering, mechanical engineering, and materials science in a very unique way.

On the catheter side, there’s a push to keep the same outer diameter — fitting through an 8.5 or 13 French sheath — while packing in more technology.

That includes:

Physicians want more data — better temperature control, better signal fidelity, force feedback — but they don’t want larger profiles.

So miniaturization becomes critical. Smaller wires, more integrated sensors, solid-state components — all within the same footprint.

Once one competitor improves mapping fidelity or tracking, that becomes the new baseline. Physicians won’t accept less.

17:46 Mapping and Ablation Catheters

Steve Maxson:

There’s been interest in all-in-one catheters that can both map and ablate. Is that still a focus?

Joe Keyes:

One thing I’ve always loved about EP is mapping. It’s like playing detective — figuring out where the bad signal originates.

There’s growing desire to reduce catheter exchanges and avoid paying for a separate mapping catheter. Efficiency is important.

However, many physicians still prefer a dedicated mapping catheter for complex cases.

Good EP companies provide options. Map-and-ablate platforms are becoming more important in workflows, but flexibility matters.

19:50 Robotics in EP Labs

Steve Maxson:

Do you see robotics becoming common in EP labs?

Joe Keyes:

There could be advantages in improved placement precision. Intuitive recently received approval for cardiac procedures.

But EP labs prioritize quick turnover. If you add a robot, that’s another system to set up and reset.

It’s exciting technology, and I’d like to see how it develops, but time will tell whether it becomes standard.

20:57 Portable EP Systems

Joe Keyes:

More portable systems, like J&J’s Aura concept, could potentially work. But again, adoption depends on workflow integration.

21:09 The Role of Nitinol in Modern EP Catheters

Steve Maxson:

Where do you see nitinol really shining as an enabler in EP?

Joe Keyes:

If you line up catheters in most fields, they look similar. In EP, they look very different.

Nitinol enables that diversity in form factors. It allows engineers to design shapes physicians need for specific workflows.

It can be used as:

  • A mechanical substrate
  • An ablation electrode
  • Part of a sensor housing

Its superelastic properties allow complex shapes that would otherwise be impossible.

23:55 Steerability and Flexibility in EP Procedures

Steve Maxson:

Many AFib cases are left-sided procedures that require crossing the atrial septum. Does that create additional demands on the catheter in terms of flexibility and steerability?

Joe Keyes:

There are trade-offs with steerability.

In the focal world — if you’re doing point-by-point ablation with something like ThermoCool STSF, Sphere-9, or Farapoint — you need precise steerability to reach very specific targets.

In the single-shot world, the standard workflow uses a steerable sheath. The catheter may be advanced over a wire, or the sheath is directed toward the pulmonary vein and the catheter is deployed from there.

It depends on the workflow you’re designing for and what physicians prefer. Some prefer point-by-point approaches, especially for non-pulmonary vein targets.

Ultimately, what you’re designing for determines the level of durability and steerability required.

26:14 Designing Safe and Effective EP Catheters

Steve Maxson:

What factors are most important in delivering energy safely and getting accurate signals at the distal tip?

Joe Keyes:

It’s a trade-off.

In pulsed field ablation, if the electrode is too small, you may not be able to deliver the current you need. You could also generate more microbubbles.

So you often want a larger electrode to ensure adequate current delivery.

On the mapping side, there are also trade-offs. If the electrode is too small, you may not capture good signals unless you use specialized coatings like iridium oxide.

Some catheters use dedicated mapping electrodes along with larger ablation electrodes. Others combine mapping and ablation in the same electrodes.

In either case, you need electrodes large enough to deliver energy but small enough to preserve electrogram fidelity.

From an engineering standpoint, you also have to consider wiring. Whatever you connect — mapping or ablation — has to be wired appropriately.

With pulse field ablation, voltage considerations change insulation requirements and wire sizing. That’s different from RF days, where it was more common to map and ablate from the same electrodes without those voltage concerns.

As pulsed field has come on board, we’ve had to rethink how to isolate and split functions safely.

28:15 Challenges and Innovations in EP Technology

Steve Maxson:

There are so many design inputs. That’s part of what makes EP exciting.

Joe Keyes:

Exactly. When I stepped away from EP and consulted in other fields, I realized how multifaceted EP is. Robotics comes close in complexity, but EP is unique.

Within the catheter itself, there are countless considerations — even polymer stiffness affects whether you can reach the vein. If you can’t reach the vein, none of the energy delivery matters.

Then there’s system integration — making sure the catheter works seamlessly with the ablation generator and mapping system.

Many meetings revolve around ensuring what works mechanically on the catheter side also functions correctly electrically and system-wide.

That complexity is part of why I came back to EP.

Steve Maxson:

Joe, this has been excellent. Thank you for walking through EP fundamentals and where the technology is headed.

Joe Keyes:

It was great talking with you. Thank you.

29:40 The Versatility of Nitinol in Medical Devices

Steve Maxson:

Jose, thanks for joining the webinar.

We were just talking about EP technology platforms. One theme that always comes up in new device innovation is nitinol. It seems like nine out of ten times, when a founder is describing their breakthrough platform, nitinol is involved.

Jose Maeso:

Absolutely. Nitinol has been the backbone of innovation, especially in electrophysiology.

We’ve seen the transition from cryoablation to pulsed field ablation, and nitinol has supported both.

Its superelasticity, deliverability, and resilience inside the body make it ideal for these devices.

Years ago, procedures required open surgery. Now physicians access the heart through minimally invasive pathways. Nitinol enables that.

33:07 Shape Memory and Superelasticity

Steve Maxson:

You’ve said before that with nitinol, the sky’s the limit. Is there a trade-off between shape memory and superelasticity when designing a product?

Jose Maeso:

Rather than a trade-off, it’s about how you use each effect.

During manufacturing, we use shape memory to train the device into its final geometry — whether that’s a sphere, a basket, or another complex form.

Once inside the body, superelasticity allows the device to maintain shape while navigating tortuous anatomy.

In some designs, shape memory can also be used for actuation — applying thermal input to trigger a shape change in vivo.

The beauty of nitinol is that the same material can exhibit different behaviors depending on processing.

37:07 Localized Mechanical Properties

Steve Maxson:

Can you localize shape memory effects in specific areas?

Jose Maeso:

Yes. Through localized heat treatment and material processing, you can create different mechanical behaviors along a single component.

One section of a device can behave differently from another, even though it’s the same alloy.

That gives engineers tremendous flexibility in design.

38:47 Balloons and Hybrid Designs

Steve Maxson:

We’ve seen more use of balloons for energy delivery. Are you seeing combinations of polymer and nitinol?

Jose Maeso:

Yes. We’re seeing hybrid technologies.

Balloons offer controlled expansion and positioning. Nitinol provides structural support and column strength.

We’ve seen balloons coated with drugs, balloons integrated with electrodes, and nitinol frames combined with polymer structures.

The market has embraced combining these technologies.

40:01 Lighteum Medical’s Role in EP Innovation

Steve Maxson:

Can you share what Lighteum Medical is doing to support EP and PFA innovation?

Jose Maeso:

At Lighteum Medical, we’re a one-stop shop for nitinol and precious metal components.

EP devices require nitinol for structural performance and precious metals for signal delivery and feedback.

We offer raw nitinol material, nitinol processing, and precision precious metal machining.

Pulsed field ablation is becoming the new standard, and we’re positioned to support that growth.

41:22 Upcoming Events and Closing Remarks

Steve Maxson:

I hope you enjoyed the conversation with Joe and Jose.

Head over to Chamfr’s Resources Hub for practical R&D tips, new technologies, and sourcing trends to accelerate development.

We also have a full slate of MPP conferences this year:

  • MPP West: April 8 in Mountain View
  • MPP East: Boston in June
  • MPP Ireland: September
  • MPP Minnesota: October

We also host monthly webinars. Next month features Travis Garrison discussing design for automation, followed by a session on PFAS alternative liner technologies.

Join Chamfr — now over 20,000 MedTech innovators — and stay updated on events, webinars, and new products.

Thanks again for joining. See you next month.