What Is HIFU Ablation?

Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95%) the arrhythmia originates in one of the four pulmonary veins (PV’s). Furthermore, it has been shown that ablation or isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.

The ProRhythm™ High Intensity Focused Ultrasound (HIFU) System for Pulmonary Vein Isolation (PVI) is designed to create circumferential lesions around the ostium of the PV in an efficient manner, resulting in the elimination of symptomatic episodes of Atrial Fibrillation.

High Intensity Focused Ultrasound (HIFU) is an investigational ablation treatment, which creates circular lesions around the pulmonary veins, delivering HIFU energy through a balloon. The energy creates reliable, complete lesions that can block the electrical impulses that cause AF.

The ProRhythm™ HIFU Ablation System

The HIFU PV Catheter consists of a multi-lumen shaft with a cylindrical piezoelectric ceramic transducer located at the distal end. The transducer converts the electrical energy to acoustic energy, which is then focused and directed into the myocardium surrounding the targeted pulmonary vein.

Focusing of the ultrasonic waves is accomplished by utilizing a parabolic reflector created by an interface of carbon dioxide gas (CO2) and water. The HIFU Catheter for Pulmonary Vein Isolation is deployed into the left atrium (LA) through a 16.5F sheath and over a 0.035” guide wire (non-hydrophilic), which is accommodated by the central lumen of the HIFU Ablation Catheter. The HIFU Ablation Catheter for Pulmonary Vein Isolation is supplied sterile (using Ethylene Oxide) and is intended for single use only.

How Does HIFU Compare With Other Ablation Treatments?

There are currently no FDA-approved ablation treatments for Atrial Fibrillation. The other technologies require repeated applications of energy at points around the pulmonary vein. Another advantage of HIFU ablation is that HIFU energy may also decrease the risk of clot formation during the procedure, reducing the risk of stroke.

HIFU Ablation Now Being Studied

Research on HIFU ablation is currently underway. Click here to learn more about the clinical study going on now, and how your patients might be able to participate.