ArticleJournal of cardiovascular electrophysiology2026
Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan.
Article in Journal of cardiovascular electrophysiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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3 authors.
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Abstract
introductionApproval timelines for ablation catheters differ across major markets, potentially delaying clinical access. This study aimed to quantify approval lags for contemporary ablation catheters across the EU, the US, and Japan.
methodsWe retrospectively identified therapeutic ablation catheters with documented approval dates in the European Union, the United States, and Japan using data from PMDA, FDA, and European notified-body/manufacturer sources. Non-therapeutic accessories were excluded. Month-level approval lags were calculated for each regional pair.
resultsTwenty-six devices met the inclusion criteria. Mean approval lags were 46.2 months for Japan versus EU, 16.7 months for Japan versus US, and 29.5 months for EU versus US. Medians were lower across all comparisons owing to several long-lag outliers. Legacy cryoablation catheters showed the greatest delays, whereas recent pulsed-field ablation systems were approved in closer temporal proximity across regions.
conclusionSubstantial cross-regional heterogeneity in ablation-catheter approvals persists, but recent PFA devices demonstrate that near-synchronous submissions can narrow the gap. Regulatory convergence and coordinated sponsor strategies may further accelerate patient access.
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