Pulse field ablation (PFA) is rapidly transforming electrophysiology (EP). Its non-thermal mechanism, tissue selectivity, and reduced collateral damage have accelerated interest in next-generation PFA mapping and ablation catheters.
At the same time, many EP catheter development programs stall before commercialization. Funding constraints, underestimated technical complexity, and late-stage manufacturing surprises are common. While full-scale PFA production is still rare across the industry, the same design and manufacturing challenges appear repeatedly, and how early teams address them often determines whether a program advances or stops.
Medical Murray supports electrophysiology catheter development through early builds and manufacturing-readiness activities. Below are the core realities teams must solve when developing pulse field ablation catheters with scale in mind.
Why PFA Catheters Are Fundamentally Different
Unlike radiofrequency (RF) or cryoablation, PFA relies on high-voltage, ultra-short electrical pulses rather than thermal energy. That single distinction changes many of the assumptions used in traditional EP catheter platforms.
Higher peak voltages, rapid pulse delivery, and non-thermal failure modes introduce new risks related to:
- Electrical insulation integrity
- Dielectric breakdown
- Conductor fatigue
- Device robustness under repeated pulsing
Catheter designs that perform well in thermal ablation environments can struggle when exposed to PFA-specific electrical stresses, especially during extended durability testing.
Shaft Design and Insulation in High-Voltage EP Catheters
Insulation integrity is one of the most underestimated risks in PFA catheter development. High-voltage pulsing exposes weaknesses that may never appear during low-voltage testing.
Development teams often balance:
- Electrical robustness vs. flexibility
- Wall thickness vs. deliverability
- Polymer performance vs. manufacturability
Early decisions around polymer selection, extrusion tolerances, bonding processes, and layer construction frequently determine whether downstream verification testing succeeds or fails.
Electrode Design in PFA Mapping and Ablation Catheters
In PFA catheters, electrode geometry affects far more than clinical performance. Electrode spacing, attachment methods, edge conditions, and surface finish all influence:
- Electrical field distribution
- Consistency under repeated pulsing
- Assembly repeatability
- Long-term durability
Early prototypes can mask issues that only emerge during process scaling or extended electrical cycling. As programs mature, holding tight positional tolerances and ensuring robust electrode attachment become critical to both performance and yield.
Wiring and Electrical Routing Challenges
PFA places unusual demands on internal wiring systems. Conductors must tolerate high peak electrical loads and repeated pulsing while fitting within extremely constrained catheter shafts.
Common challenges include:
- Conductor fatigue and insulation damage
- Connector reliability
- Strain relief at transition points
- EMI and signal integrity concerns
Because wiring architectures are often locked early, insufficient evaluation can create late-stage reliability or manufacturability risks.
Deliverability Still Defines Clinical Success
Even the most advanced mapping and ablation catheter must still perform mechanically. Torque response, pushability, kink resistance, and compatibility with transseptal workflows remain critical.
Electrical performance and catheter feel cannot be separated. Successful EP devices treat mechanical and electrical design as a single system.
Designing EP Catheters for Manufacturing Readiness
Designing for manufacturability begins long before production volumes exist. Teams preparing EP catheters for scale must eventually understand:
- Where defects are most likely to occur
- Which tolerances truly matter
- How the device will be inspected and tested during assembly
Programs that integrate manufacturing thinking early are better positioned to avoid late-stage redesigns, yield loss, and unexpected verification failures.
Verification and Testing Considerations for PFA Catheters
PFA programs often require testing beyond what is typical for thermal ablation devices. High-voltage dielectric testing, electrical durability cycling, and simulated use with repeated pulsing can all reveal issues that were not apparent earlier in development.
Planning for these tests early helps protect both timelines and budgets.
Why Many PFA Programs Stall
Across the industry, PFA catheter programs frequently slow or stop due to:
- Capital intensity
- Underestimated electrical and manufacturing complexity
- Late discovery of scale-up constraints
In many cases, the outcome is determined not by clinical concept, but by early design and manufacturing decisions.
Build FPA Catheters with Scale in Mind
PFA catheter development rewards teams that integrate engineering, materials, and manufacturing thinking early.
If you are developing a PFA mapping or ablation catheter and want manufacturing input before design lock, we are always open to a technical conversation. Contact us!