Atrial fibrillation (AFib) is an irregular, often very rapid heart rhythm. During AFib, the heart’s atria beat out of sync with its ventricles. Because not enough blood is pumped out of the atria, blood pools in the area, which can clot. The condition increases the risk of stroke, heart failure, and other cardiac complications.

For many, AFib has no symptoms. But for some, it can cause a fast, pounding heartbeat, shortness of breath, or light-headedness. 

“My heart flip-flops, skips beats, and feels like it’s banging against my chest wall, especially if I’m carrying stuff up my stairs or bending down,” one patient said on the American Heart Association’s website.

It’s estimated that by 2030, the prevalence of AFib will rise to 12.1 million cases in the U.S.¹ In 2021, AFib was mentioned on 232,030 death certificates and was the underlying cause of death in 28,037 of those deaths. The risk grows with age and high blood pressure accounts for approximately one in five cases of AFib. AFib is also associated with an about fivefold elevated risk of ischemic stroke, and it causes about one in seven strokes.

A common treatment for AFib is ablation, which uses small burns or freezes heart cells to cause some scarring on the inside of the heart. This helps to break up or insulate the electrical signals that cause irregular heartbeats, helping the heart maintain a normal rhythm.

During ablation, a catheter is inserted into a blood vessel in the groin that is threaded up to the heart. Once the catheter is inside the heart, software mapping systems are used to study electrical signals as they occur and navigate where to position the catheter. The catheter is then used to burn or freeze an organized scar in a small area of the heart when the abnormal signal starts. Scar tissue doesn’t conduct electrical signals inside the heart, so creating a scar with the ablation helps prevent the heart from conducting the abnormal signals that cause AFib.

Radiofrequency ablation (RFA) leverages RF energy to burn the cardiac tissue. However, complications can arise from unintentional thermal injury of the esophagus during RFA, causing esophageal ulcers and, rarely, atrioesophageal fistulas.

Due to the growing prevalence of AFib around the globe, physicians seek innovative methods to improve the efficiency of ablation procedures and provide better treatment outcomes for people with the disease.

“Pulsed field ablation (PFA) represents a new approach to treating AFib, utilizing a controlled electric field to ablate and scar cardiac tissue through a process called irreversible electroporation (IRE),” Jasmina Brooks, president of Johnson & Johnson MedTech Electrophysiology told MPO. “Because the process involves minimally thermal energy to ablate target cardiac tissue and demonstrates tissue selectivity, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.”

PFA is one of the most competitive spaces in the cardiovascular market at present. J&J MedTech entered the PFA market in January 2024 with Japanese regulatory approval of its VARIPULSE system. The company is not alone—several other medtech giants have begun establishing themselves in PFA. 

The Farapulse pulsed field ablation system earned FDA approval in January. Photo: Boston Scientific

Medtronic’s PulseSelect PFA system earned CE mark approval in November 2023, and won U.S. Food and Drug Administration (FDA) approval about a month later. Boston Scientific’s Farapulse PFA system grabbed an FDA nod a month after that. Abbott Labs completed the first procedures with its Volt PFA system in January as well, finishing enrollment for its VOLT-AF IDE study in October. 

Another player in the PFA space is Pulse Biosciences. The company’s FDA breakthrough status nanosecond-PFA (nsPFA) cardiac surgery system was used to treat the first two AFib patients in its first-in-human feasibility study in August.

“The adoption curve for PFA has been unprecedented in the medtech space,” said Brooks. “In H1 2024, the worldwide electrophysiology (EP) market grew 24%, driven by PFA.”

That’s not to say PFA will replace RF ablation to treat AFib. Conventional catheter ablation technologies may have shortcomings when treating persistent AFib,² but they are quite successful in treating paroxysmal AFib. J&J MedTech is in the midst of its SmartfIRE clinical trial, which is evaluating the company’s investigational Dual Energy THERMOCOOL SMARTTOUCH SF Catheter to deliver RF and PFA to treat paroxysmal AFib.

“While PFA represents an exciting innovation, we have decades of data on the safety and effectiveness, as well as EP familiarity, with RF ablation catheters,” said Brooks. “Dual energy catheters—those that can deliver both RF and PF energy—will enable EPs to customize procedures based on patient need.”

J&J MedTech’s VARIPULSE platform features a variable loop size of 25-35 mm to adjust to the patient’s anatomy. The PFA catheter’s 10 electrodes electro-anatomically map and emit pulsed field for ablation and allow pacing per electrode. Three single axis sensor locations on the catheter allow accurate visualization on the CARTO system. The catheter is built on a bi-directional, 8 Fr platform that’s compatible with the company’s CARTO VIZIGO sheath or similar 8.5 Fr inner lumen sheath.

“The VARIPULSE Platform is comprised of the VARIPULSE Catheter, a fully integrated variable-loop multielectrode catheter; the TRUPULSE Generator, a PFA generator; and the CARTO 3 System VARIPULSE Software, which provides full integration with the world’s leading 3D cardiac mapping system,” explained Brooks. “The VARIPULSE Platform offers the versatility of a regional ablation catheter, a simple generator user interface, and a mapping system that provides an intuitive, reproducible workflow with real-time visualization, tissue proximity indicator for contact visualization, and PF tagging mechanisms.”

J&J announced that VARIPULSE received CE mark approval in February of this year to treat symptomatic drug refractory recurrent paroxysmal AFib. At the time of writing, the company is awaiting FDA premarket approval for VARIPULSE, having submitted it to the agency in March.

Further data was presented in May from J&J’s pivotal admIRE study of 277 participants with paroxysmal AFib. Highlights included 74.6% overall primary effectiveness success, with a 2.9% overall primary adverse event rate.³ J&J reported that all patients achieved acute procedural success, with a median procedure time of 81 minutes in pulmonary vein isolation (PVI)-only procedures, 90 minutes in all procedures, and a fluoroscopy time of 7 minutes. Twenty-five percent of procedures were performed without fluoroscopy, with no impact to safety or efficacy due to the full integration of the VARIPULSE platform with the CARTO 3 system.

Version 8 of the company’s CARTO 3 mapping and ablation solution launched in May this year. CARTO 3 is a 3D mapping system that uses electromagnetic technology to create real-time maps of cardiac structures. It first launched in 2009.

The latest version of the 3D heart-mapping system’s software features the new CARTO FAM module, an artificial intelligence (AI) algorithm that automatically generates left atrial anatomy before inserting the catheter into the left atrium. A new CARTO ELEVATE module includes new features like multipolar with the OPTRELL mapping catheter, complex signals identification, pattern acquisition, and an enhanced CONFIDENSE module to create optimized maps with higher overall Smart Index scores.

Advanced heart mapping is an essential tool in order to ensure optimal catheter placement for a cardiac ablation procedure. Abbott Labs earned FDA clearance in October for its Advisor HD Grid X Mapping Catheter, Sensor Enabled to further support mapping of both PFA and RF ablation cases. Boston Scientific’s PFA solution leverages its Farawave integrated mapping module to visualize its Farawave Nav catheter. Medtronic’s PulseSelect PFA system was designed as a “plug-and-play” system that can be used with any mapping system or with only fluoroscopy.

“Our innovation has always been driven by the real-world needs of physicians, including pioneering the first real-time, 3D cardiac mapping and navigation technology,” said Brooks. “Even as ablation energy sources evolve, a fully integrated 3D mapping system remains the cornerstone of catheter ablation, enabling accurate, real-time catheter visualization and empowering electrophysiologists to make optimal, patient-tailored treatment decisions.” 

Manufacturing Partners Don’t Miss a Beat

No two devices used in pulsed field ablation look anything alike; there’s not a standard shape for the catheters coming from the various medical device makers in the market.

Medtronic’s PulseSelect system has a catheter in a loop shape with nine electrodes. The company’s Affera Sphere-9 is configured in a nitinol lattice as one spherical electrode, and its Affera Sphere-360 is adjustable to different shapes: a sphere, a linear configuration, and a pancake shape. Johnson & Johnson MedTech’s VARIPULSE system catheter is in a different loop shape, with 10 electrodes. Boston Scientific’s FARAWAVE catheter has variable basket and flower shapes, with 20 electrodes. Abbott’s Volt PFA catheter is a balloon-in-basket design with electrodes that face outward.

In addition to the catheter that delivers the PFA therapy, these systems are accompanied by a pulsed field generator and some sort of heart mapping solution. As such, cardiac ablation device makers might rely on a manufacturing partner with expertise in these technologies to assist them.

Over the past few weeks, MPO spoke to various experts in manufacturing devices and components used in cardiac ablation and pulsed field ablation to glean more insights about the market and describe the various services necessary to manufacture the components of an ablation system.

John Cooney, VP of Research & Development, Integer Holdings Corporation: We are confident in the role PFA will play in driving our growth as more PFA products are commercialized with this very innovative technology, which is revolutionizing the EP market. Integer is well-positioned to support the industry growth given our exposure across the EP landscape. PFA procedures are gaining traction, and we expect this to continue as the adoption of PFA procedures expands globally. We are well prepared to support this momentum.

With the rise of PFA, we are well-positioned to provide value through our production of critical components, complex subassemblies, and finished delivery devices for ablation and mapping catheters. Our broad exposure to the EP market means we can offer end-to-end support, including steerable sheaths, mapping catheters, ablation catheters and other vital devices that enable both PFA and legacy ablation technologies.

Dan Lazas, Vice President of Sales & Marketing, Nordson Medical: While previous technologies have leveraged our balloon expertise, PFA technologies continue to leverage our expertise in many other component technologies, such as Pebax, nylon, PTFE, FEP, and PET tubing and heat shrinks. We also offer development and assembly solutions of these components into fully composite ablation catheter shafts.

Robert Morin, VP of Sales, PDC: We’ve seen an uptick in minimally invasive surgical applications, including PFA. Often, the PFA procedure is outpatient, with a shorter recovery time than previous treatment modalities. In some cases of severe AFib, a patient can receive a pacing device to provide complete cardiac rhythm management along with the ablation procedure, which will disrupt abnormal cardiac electrical signals that serve as the root cause of the AFib. The result is a device-driven rhythm management solution for patients that avoids the need to take numerous medications to manage the condition. We make multiple products that are integrated into minimally invasive cardiac surgery procedures, supporting the patient’s treatment and post-treatment care during recovery. As these procedures grow, we anticipate continued growth and product expansion.

We support the cardiac ablation market by offering specialized micro-molding and over-molding services. Our ability to over-mold rigid plastics with Pebax enhances device performance, especially in catheter tips and electrodes. We also incorporate radiopaque markers and inserts, such as platinum-iridium or tantalum, to ensure devices are visible during ablation procedures.

With more medical device OEMs working on these devices, PFA systems require precise energy delivery, often involving over-molding rigid components with Pebax to balance flexibility and insulation. Our expertise in incorporating radiopaque materials, such as tungsten-loaded Pebax, ensures these devices maintain high visibility during procedures, helping manufacturers meet the complex requirements of this advanced technology.

Matyou Shahbaz, General Manager, Cirtec Santa Clara: The most popular requests from our cardiovascular device manufacturing partners are smart catheters with integrated electronic delivery systems, high-voltage catheter technology, microcatheters, deflectable and steerable shafts, and manufacturing line transfers to cost-efficient regions.

We support the cardiac ablation market with in-house pull ring assemblies, multi-lumen extrusion, with deflectable and steerable catheter manufacturing and assembly. We deliver high-volume production released electrode welded assemblies through laser processing and automation, under Costa Rica manufacturing as well. Our electrical, firmware, ASIC, and software engineering teams also help design ablation electrical generators.

Pete Soupir, VP and Segment Lead, MedTech, Phillips-Medisize, a Molex company: The emergence of PFA has led to an increased demand for our services because of our expertise in complex interconnect assemblies, custom connectors, fiber optics, and fine wire termination. In the past year, we have helped our customers support surgeons who performed more than 5 million cardiovascular surgeries.

For PFA, another reason we have seen high demand and have been able to differentiate our offering, relates to the emphasis on interconnect solutions due to the need for higher pin count densities. As the capabilities of catheters continue to advance, selecting the correct interconnect partner early in the process is essential to achieve the best time-to-market and total cost of ownership outcomes due to increased connector requirements (signal density, small mechanical envelope, and high voltage).

Lisa Vickers, Strategic Account Manager, Nordson Medical: Cardiac ablation for our customers is all about control and minimal impact to the patient. It’s crucial that these catheters are designed to be effective, atraumatic, and have a great deal of precision when it comes to temperature and location accuracy. This type of precision leads to safer and more efficient surgeries—which patients, physicians, and insurance providers care a lot about.

Source:MPO