Cardiac diagnostics: supporting more sensing in smaller, fatigue-resistant designs

Cardiac diagnostics: supporting more sensing in smaller, fatigue-resistant designs

A Q&A with Cacie McDorman, Ph.D., Global Product Manager – Wire Technologies, Alleima Medical

Physicians are asking for more, and better, data during cardiac diagnostic and therapeutic procedures. Sensor integration is shifting from “add-on” measurements to embedded, multi-parameter platforms that can support real-time decisions in the EP lab and longer-term insights for chronic conditions like heart failure.

This evolution creates an engineering tension that is not uncommon: add more sensing capabilities without increasing size, sacrificing flexibility, or compromising reliability over millions of cycles.

To explore the shifting landscape and what it means for OEMs, Medical Device Network spoke to Cacie McDorman, Ph.D., Global Product Manager for Wire Technologies at Alleima’s medical unit.

Q: Which signals matter most for cardiac diagnostics today, and what new signals are you evaluating?

Cacie McDorman (CM): The core signals are still surface electrocardiogram (ECG) and intracardiac electrograms because they are the foundation for rhythm diagnosis, mapping, pacing response, and ablation endpoints. Pressure, impedance, temperature, and imaging add important context: pressure helps with hemodynamics; impedance can indicate tissue or fluid changes; temperature supports safety, and ultrasound or intracardiac echo helps with anatomy and device position.

The newer areas we’re watching are less about one specific signal and more about adding practical insight at the treatment site. So, for example, things like tissue contact and proximity, local impedance or conductivity, distributed temperature, electro-mechanical motion, optical or ultrasound-based tissue information, and local field exposure, for example, in pulsed field ablation (PFA).

From an Alleima wire-technology perspective, the opportunity is to support more sensing channels in smaller, fatigue-resistant designs while maintaining low-noise signal transmission, isolation, and manufacturability.

Q: For multimodal sensing, what combinations create the most actionable clinical insight?

CM: The best combinations are the ones that help answer a real procedural question. For electrophysiology (EP) and ablation, electrograms (EGM) combined with contact or proximity, local impedance, and mapping or imaging is especially useful because it connects the electrical response, catheter–tissue interaction, tissue interface, and anatomy. EGM shows what the myocardium is doing, contact or proximity helps confirm whether energy is coupling into the tissue, impedance adds interface context, and imaging or mapping confirms whether the right area has been treated.

From a wire-technology standpoint, multimodal sensing usually means more conductors, more terminations, and more insulation interfaces in the same, or smaller, device footprint.

Q: What are the biggest barriers to integrating additional sensors into existing catheter, lead, or platform architectures?

CM: The biggest barriers are space, reliability, and system integration. Every added sensor competes for space, insulation thickness, termination area, and flexibility. Materials also have to work with electrodes, coatings, polymers, sterilization, blood contact, and long-term fatigue requirements.

EMI becomes a bigger issue when low-level sensing signals sit close to high-energy therapy lines—especially in PFA. Power and heat matter for active sensors, and cost and yield ultimately decide whether the technology can scale.

In many cases, the toughest issues show up at the interfaces: sensor-to-wire, wire-to-connector, coating-to-metal, and catheter-to-console. That’s why early co-development between the OEM and supplier is so important.

Q: What level of accuracy or latency is required for sensor data to be clinically meaningful during real-time procedures?

CM: It depends on the decision the data is supporting. EGM and ECG signals need millisecond-level timing, stable sampling, and low noise because they guide rhythm diagnosis, mapping, and immediate ablation decisions. Contact, proximity, and force data need to update fast enough to reflect catheter movement and tissue engagement in real time.

Temperature may support sub-second to seconds-level safety monitoring, while pressure and flow need enough waveform fidelity to support acute hemodynamic decisions. For heart failure monitoring, the focus is usually less on latency and more on trend accuracy, drift stability, and long-term consistency.

Q: How are EP labs and cardiologists quantifying ROI for added sensing?

CM: Added sensing has value when it reduces uncertainty, shortens procedure time, improves lab throughput, reduces fluoroscopy or anesthesia time, lowers complication risk, improves first-pass success, or reduces repeat procedures. EP labs also look at training, operator variability, and whether the technology helps standardize outcomes across physicians.

The real test is whether the sensor changes the workflow in a useful way during the case. If it only creates more data without making a decision easier, it will be hard to justify the added cost.

Q: In PFA, what measurements best predict lesion success—and how does the high-voltage environment change sensor requirements?

CM: At this point, I would not treat any single intra-procedural measurement as a complete predictor of durable PFA lesion success. The better approach is a combination of catheter-tissue contact or proximity, delivered field or dose, electrogram response, local impedance behaviour, anatomic coverage, and post-ablation mapping. The industry is moving toward validated lesion-quality indices, but those will need to be system-specific.

PFA changes the sensor architecture quite a bit. Low-level EGM, pressure, or temperature signals may sit in the same catheter, cable, or connector ecosystem as high-voltage, microsecond-scale pulses. That creates tougher requirements for dielectric strength, leakage control, grounding, shielding, filtering, and signal recovery after pulse delivery. From a wire and coating standpoint, insulation quality, coating uniformity, pinhole control, conductor spacing, fatigue resistance, and termination integrity become safety-critical design inputs—not commodity specifications.

Q: What does “design for manufacturability” look like when adding sensing to disposable devices?

CM: We need to think about manufacturability from the concept stage, not after the design is already locked. That means choosing wire constructions and material systems that can be drawn, coated, wound, welded, laser processed, bonded, or terminated consistently at scale. It also means planning how the sensor will be tested during production—continuity, insulation resistance, dielectric strength, signal noise, tensile strength, fatigue, surface condition, and sterilisation impact.

A sensing feature that works in a prototype but cannot survive downstream processing, handling, sterilization, shelf life, and high-volume assembly is not really a product yet.

This is where specialist materials and precision-engineered wire becomes strategic. Swedish owned Alleima with its 160+ years of experience combines advanced alloys, metallurgical expertise and consistent, medical-grade production to support global OEMs develop the next generation of robust sensor-enabled instruments with its custom-made wire-based solutions.

Find out more information about Alleima’s sensor integration solutions at their website www.alleima.com/sensing or download the whitepaper below.

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