Limitations:
This study was conducted in healthy swine and results may vary in humans
or in scarred or diseased tissue. Lesion assessment was done on fresh
TTC-stained tissue and all images were retrospectively analyzed for
lesion dimensions using methods that are well established preclinically
but impossible to validate clinically. Steps were taken to ensure
measurement systems were calibrated correctly and TTC procedures were
identical in all animals. All findings in this study use a proprietary
biphasic waveform and investigational catheter design that may not be
generally applicable for predicting treatment results of different PEF
waveforms, systems, and catheters.