Research Disclaimer
Biosense Webster is developing a comprehensive suite of pulsed field ablation (PFA) products that are at different development stages. Some of the technologies described herein are not available for sale in the regions pending regulatory approval. The VARIPULSE™ Catheter and the TRUPULSE™ Generator have received FDA approval in the United States, and CE mark for use in the European Union. The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter has received CE mark for use in the European Union. The OMNYPULSE™ Catheter is investigational and has not received regulatory approval. For approved devices, please refer to the corresponding "Instructions For use" online at e-ifu.com for complete approved indications for each region.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
