Approval lags for ablation catheters were 46.2 months for Japan vs EU, 16.7 months for Japan vs US, and 29.5 months for EU vs US, with recent devices narrowing these gaps.
What are the approval lags for contemporary ablation catheters across the EU, the US, and Japan?
Substantial cross-regional heterogeneity exists in ablation-catheter approvals between the EU, US, and Japan, though recent pulsed-field ablation devices demonstrate narrowing gaps.
ABSTRACT Introduction Approval 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. Methods We 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. Results Twenty‐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. Conclusion Substantial 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.
Li et al. (2026) studied this question. Approval lags for ablation catheters were 46.2 months for Japan vs EU, 16.7 months for Japan vs US, and 29.5 months for EU vs US, with recent devices narrowing these gaps.