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. Pulsed field ablation technologies are not approved in the United States. The VARIPULSE™ Catheter and TRUPULSE™ Generator received CE mark. The Dual Energy THERMOCCOL SMARTTOUCH™ SF Catheter and the OMNYPULSE™ Catheter are investigational and have not received regulatory approval. The Laminar Left Atrial Appendage Elimination System is investigational and has not received regulatory approval. For approved devices, please refer to the corresponding "Instructions For use" online at https://www.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.