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The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.

The esolution® Esophageal Retractor is a sterile mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy. The esolution® Esophageal Retractor contains two main components: an Outer Sheath, which is placed in the esophagus prior to the initiation of the therapeutic ablation procedure and a Mechanical Deflection Device that is inserted into the Outer Sheath once the Outer Sheath has been positioned in the esophagus for the indicated atrial fibrillation ablation therapeutic care. The purpose of this 510(k) is to capture the modifications made to the esolution® Esophageal Retractor required for manufacturability including changes to materials and design.