The HIFU ablation catheter focuses and concentrates ultrasound to create a circumferential, transmural lesion which, when properly located at the ostium (exit) of a pulmonary vein in the left atrium, is intended to create electrical isolation of that vein.

The lesion can prevent any ectopic foci (source of unwanted electrical stimulation) present in that vein from triggering and/or sustaining AF.

The PRI ablation catheter focuses therapeutic ultrasound energy by a proprietary dual balloon design which creates a parabolic gas-fluid interface that reflects and vectors concentrated ultrasound to create a required circumferential lesion in the atrium, around the PV. Ultrasound energy outside of the focal zone passes harmlessly through the blood or tissue. This design is intended to allow the catheter to apply energy to create a discreet, predictable and controllable ablation lesion at the intended ablation site, minimizing the application of energy to unintended tissue in order to reduce complications from the procedure.

CAUTION: Investigational device. Limited by United States law to investigational use.