Kardium has achieved a transformative milestone in its journey to reshape cardiac electrophysiology, announcing that the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Alongside the PMA, the FDA also granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software, giving the Canadian company a fully integrated platform cleared for commercial use in the U.S.
With this regulatory approval, Kardium officially joins the increasingly competitive U.S. PFA market, which already features some of the industry’s biggest players: Medtronic (Affera), Boston Scientific (Farapulse), and Johnson & Johnson MedTech (Varipulse). The green light positions Kardium as a serious challenger in a market segment widely considered the future of atrial fibrillation (AFib) treatment.
What makes Globe unique
Kardium touts the Globe platform as the only integrated, high-density mapping and ablation system capable of combining:
Single-shot pulmonary vein isolation (PVI).
Customizable, targeted ablation.
High-definition cardiac mapping.
All of this is accomplished with a single catheter, streamlining workflow and giving physicians greater versatility during procedures.
At the heart of the system is the Globe catheter, which features a 122-electrode array supported by advanced mapping software. This enables rapid PVI with remarkable precision, averaging just 1.2 applications per vein. The device also allows electrophysiologists to map atrial anatomy in high definition and ablate anywhere in the atrium, offering both efficiency and personalization in treatment.
Globe’s proprietary Contact map technology provides real-time insights into which electrodes are in contact with cardiac tissue. This ensures that therapy is delivered effectively and consistently—critical for improving outcomes and reducing the need for repeat procedures.
Backed by strong clinical and financial momentum
The FDA approval builds on a foundation of encouraging clinical evidence and financial backing. Earlier this year, Kardium shared results from its PULSAR IDE trial, which provided robust support for Globe’s safety and efficacy. The trial demonstrated high success rates in pulmonary vein isolation with minimal complications, bolstering confidence that the system can compete head-to-head with other PFA platforms.
In July, the company announced it had raised $250 million in growth capital to support the commercialization of Globe. The funding round underscored investor conviction that PFA represents the next major wave in AFib therapy and that Kardium’s integrated approach offers a differentiated value proposition.
Leadership perspective
For Kardium’s leadership, FDA approval represents both validation and opportunity.
“The FDA approval of the Globe system represents the most significant milestone in the life of Kardium,” said Kevin Chaplin, CEO of Kardium. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AFib. The Globe system supports a personalized, efficient, and effective AFib treatment.”
Chaplin’s statement reflects the company’s long-term strategy: not just to enter the PFA space but to redefine how ablation procedures are performed by integrating mapping and ablation into a single, seamless system.
Why this matters for AFib treatment
Atrial fibrillation (AFib) is the most common sustained cardiac arrhythmia, affecting more than 37 million people worldwide. It is associated with increased risks of stroke, heart failure, and reduced quality of life. Catheter ablation has become a mainstay therapy for patients who do not respond to medication, but traditional thermal ablation methods—radiofrequency (RF) and cryoablation—carry risks of collateral damage, lengthy procedure times, and inconsistent outcomes.
Pulsed field ablation (PFA) is emerging as a game-changing modality because it uses nonthermal energy to selectively target myocardial tissue while sparing surrounding structures such as the esophagus and phrenic nerve. This translates into faster, safer, and more predictable procedures. With Globe, Kardium is entering this fast-moving sector with a solution that not only delivers PFA but also incorporates high-density mapping and versatile ablation options, offering electrophysiologists a more comprehensive toolset.
Strategic significance
By securing FDA approval, Kardium has achieved three strategic goals simultaneously:
Validation of its technology through rigorous regulatory scrutiny.
Commercial entry into the U.S., the world’s largest and most lucrative electrophysiology market.
Differentiation from competitors by offering the only single-catheter system with integrated mapping and ablation.
The company is now well-positioned to challenge entrenched players while offering hospitals and physicians a novel alternative that could simplify workflows, reduce costs, and improve patient outcomes.
Competitive landscape: Kardium enters the PFA race against Medtronic, Boston Scientific, and J&J
With FDA approval of the Globe pulsed field ablation (PFA) system, Kardium steps directly into one of the most competitive arenas in MedTech today. The U.S. PFA market is rapidly evolving, with major players like Medtronic, Boston Scientific, and Johnson & Johnson MedTech already pushing their own platforms forward. Each company views PFA as the next frontier in atrial fibrillation (AFib) treatment, poised to supplant thermal ablation technologies that have dominated for decades.
Why PFA is reshaping the market
Traditional ablation approaches—radiofrequency (RF) and cryoablation—have proven effective in many patients, but both are thermal-based technologies that carry risks of damaging nearby tissue such as the esophagus, phrenic nerve, or coronary arteries. They also require lengthy procedures and often repeat treatments.
Pulsed field ablation (PFA) represents a paradigm shift. By using nonthermal electrical pulses, PFA selectively ablates cardiac muscle cells while sparing surrounding tissues. This creates a more precise, faster, and safer procedure. Early studies suggest PFA could reduce complication rates, shorten recovery, and improve long-term success.
As adoption accelerates, analysts predict the global PFA market could reach billions of dollars annually by 2030, making it one of the most attractive growth segments in cardiovascular care.
The big three competitors
Medtronic (Affera system)
Medtronic strengthened its position in 2022 by acquiring Affera, whose Sphere-9 catheter integrates mapping and ablation in a single device. Affera received CE Mark in Europe and is advancing through FDA trials. Medtronic brings a massive commercial infrastructure and established relationships with electrophysiologists worldwide.
Boston Scientific (Farapulse system)
Boston Scientific made headlines in 2021 with its $1.15 billion acquisition of Farapulse. Its Farawave catheter has become a leading name in PFA, supported by strong clinical data and early adoption in Europe. With FDA approval expected soon, Boston Scientific is positioned as a near-term market leader in the U.S.
Johnson & Johnson MedTech (Varipulse system)
Biosense Webster, J&J’s electrophysiology unit, is advancing its Varipulse catheter along with the Carto mapping system. Leveraging its dominant presence in cardiac mapping, J&J aims to pair PFA with its ecosystem of navigation tools. The company’s brand equity in electrophysiology makes it a formidable contender.
How Kardium differentiates
Against this backdrop, Kardium’s Globe system brings a distinct value proposition:
Integration in one device. Globe is the only PFA platform that combines high-density mapping and ablation into a single catheter, eliminating the need for multiple tools.
122-electrode array. This enables rapid pulmonary vein isolation (PVI) with an average of just 1.2 applications per vein, while also allowing targeted ablation elsewhere in the atrium.
Proprietary Contact maps. Globe’s sensors identify which electrodes are in contact with tissue, giving operators immediate feedback and enhancing procedural precision.
Versatility. While most PFA systems focus narrowly on PVI, Globe supports both single-shot isolation and customized lesion sets, appealing to electrophysiologists who treat more complex AFib presentations.
This combination of efficiency and flexibility could make Globe attractive to hospitals seeking workflow simplificationand electrophysiologists who value control and adaptability in challenging cases.
The PFA adoption curve
Globally, PFA is still in its early adoption phase. In Europe, where many systems already hold CE Mark, uptake is accelerating as clinical data validates safety and durability. In the U.S., FDA approvals are beginning to open the market, creating a first-mover advantage for companies like Boston Scientific and now Kardium.
For Kardium, entering at this moment offers both opportunity and risk. On one hand, the company can ride the wave of enthusiasm for PFA and differentiate with its integrated design. On the other hand, scaling commercially against multinational giants will require significant capital, strategic partnerships, and aggressive training programs to win physician trust.
Investor and industry momentum
Kardium’s $250 million funding round earlier this year reflects investor conviction that Globe can secure meaningful market share. The company’s focus on clinical validation (via the PULSAR IDE trial) strengthens its credibility, especially as physicians demand robust real-world evidence before adopting new ablation systems.
From an industry perspective, Kardium’s FDA approval underscores the broader momentum of PFA. As more players enter, competition will likely drive faster innovation, more robust data generation, and expanded indications beyond paroxysmal AFib. The end result could be a reshaping of the entire electrophysiology landscape, where thermal energy becomes the exception rather than the norm.
Strategic outlook
Kardium’s challenge now is to carve out a distinct identity in a market dominated by giants. Success will hinge on:
Demonstrating clear clinical advantages through ongoing trials and registries.
Building a scalable commercial presence in the U.S. and leveraging existing adoption in Europe.
Partnering with leading electrophysiology centers to drive training and early adoption.
If successful, Kardium could position Globe not just as another PFA system but as the go-to integrated platform for electrophysiologists seeking both mapping and ablation in one tool.
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