Mechanism of Action In performing the procedure, the catheter is advanced into the right atrium over a guidewire. Once the catheter is in place, vacuum is applied to hold the septum primum and septum secundum in place. The two layers of tissue are then fused with radiofrequency energy applied via the electrode. 1. A guidewire is introduced to access and cross the PFO for balloon sizing and device placement. 2. The PFx™ Catheter is advanced into the right atrium over the guidewire. The positioning of the device is confirmed using fluoroscopy and TEE or ICE. 3. Vacuum pressure is applied to hold the septum primum and secundum in place. Radiofrequency energy is applied to close the PFO.
Exclusively for Clinical Investigation