Europe: The HIFU Ablation System has received the European CE Mark for its High Intensity Focused Ultrasound (HIFU) Ablation System for the treatment of AF. The CE Mark certification allows ProRhythm to begin marketing its system throughout the European Union. The HIFU system will be marketed through ProRhythm’s exclusive distributor for Europe, SJM International, Inc., a subsidiary of St. Jude Medical, Inc.

United States: ProRhythm has completed the feasibility trial of the HIFU Ablation System. ProRhythm has received unconditional approval by the United States Food and Drug Administration (FDA) allowing the company to proceed into the pivotal phase of the Investigational Device Exemption (IDE) Trial for the treatment of symptomatic, paroxysmal Atrial Fibrillation. Enrollment in the trial is currently underway. Click here for information on participating hospitals.