PRORHYTHM GETS CE MARK FOR HIFU ABLATION SYSTEM
ProRhythm has received the European CE Mark for its High Intensity Focused Ultrasound (HIFU) Ablation System for the treatment of atrial fibrillation (AF), allowing the company to begin marketing its system throughout the EU.
The HIFU balloon catheter is inserted through a vein in the leg of the patient and advanced into the left atrium of the heart. Controlled, discrete ablation lesions around the pulmonary veins, created with the HIFU catheter and controlled by ProRhythm's proprietary automated system, stop unwanted electrical impulses from disrupting the heart's normal rhythm. European clinical trials have demonstrated that a significant percentage of patients undergoing the HIFU ablation procedure have experienced a complete elimination of AF episodes with a single treatment procedure.
The HIFU system will be marketed through St. Jude Medical subsidiary SJM International, ProRhythm's exclusive distributor for Europe. Meanwhile, ProRhythm's HIFU system is currently under investigation in clinical trials in the U.S. to treat AF.