ProRhythm has developed a catheter-based system for the treatment of AF and, in particular, for the electrical isolation of the pulmonary veins in the left atrium.

The catheter uses High Intensity Focused Ultrasound (HIFU) energy that is focused via a reflecting balloon configuration to deliver sufficient energy to achieve ablation in a specific areas of focus. 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, creates electrical isolation of that vein. The lesion prevents ectopic foci (source of unwanted electrical stimulation) present in that vein from triggering and/or sustaining AF.

The PRI catheter employs a proprietary ultrasound reflector configuration to direct and accurately focus ultrasound ablative energy. The interface between the fluid (water balloon) and the gas (CO2 balloon) provides the reflective surface.

The PRI HIFU ablation catheter allows the physician to perform ablation without having to be in perfect or continuous contact with the target tissue. The ability to perform ablation through blood without causing coagulation enables easier positioning of the catheter at the ostium of the pulmonary vein.

To view a video and find out more about how HIFU works, click on the picture.

CAUTION: Investigational device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations