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 Currently available percutaneous techniques involve the implantation of a device for closure of PFO. Use of the PFx Closure System™ involves the application of radiofrequency energy in the right atrium to weld together the septum primum and septum secundum, thereby closing the PFO without leaving an implantable device in the heart and while applying the treatment exclusively within the right atrium. Tissue welding requires three basic steps to achieve a successful weld. First, the tissues to be joined are heated to a temperature sufficient to denature the collagenous fibers within the tissue.
Second, sufficient pressure is applied to allow intermingling and binding of the partially denatured collagen of the tissues to be joined. Last, the heat source is removed while maintaining pressure to allow the collagen to reorient in its new configuration, resulting in a tissue bridge between the previously separate tissues.
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| 1. A guidewire is introduced to access and cross the PFO for balloon sizing and device placement. |
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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. |
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3. Vacuum pressure is applied to hold the septum primum and secundum in place. Radiofrequency energy is applied to close the PFO. |
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