St. Jude Medical, Inc. has announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy(TM) Cool Path(TM) Ablation Catheter. This marks the company’s first entry into the irrigated catheter ablation market in Japan. The Therapy Cool Path Ablation Catheter is a thin, flexible tube that delivers radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars.

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The FDA has cleared the way for St Jude Medical Inc to launch its new EnSite velocity Cardiac Mapping System. The new system has been designed to help doctors diagnose and guide therapy to treat abnormal heart rhythms. The system, used in minimally invasive electrophysiology procedures, uses catheters with electrodes inserted into a cardiac chamber. The electrodes then relay electrical information from the heart in a 3-D anatomical model.

St. Jude Medical Inc has received approval from the US Food and Drug Administration (FDA) for a pair of wireless-ready pacemakers called the Accent RF pacemaker and Anthem RF CRT-P (for cardiac resynchronization therapy pacemakers). These pacemakers can wirelessly communicate with a programmer used by the clinician or a home monitor.

Japan’s Ministry of Health, Labor and Welfare has granted regulatory approval to St. Jude Medical for its SJM Tailor flexible ring and band. These products are used to repair damaged mitral and tricuspid heart valves in the heart. These are the company’s first heart valve products being released in Japan and already have approval in the U.S. and Europe.