St. Jude nets Japan, EU approval for ablation catheters

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The Japanese Ministry of Health, Labor and Welfare has granted regulatory and reimbursement approval of St. Jude Medical’s Therapy Cool Path ablation catheter, in the same week that the company reported European CE Mark approval of its Therapy Cool Flex ablation catheter.

The Therapy Cool Path ablation catheter is a tube that delivers radiofrequency (RF) energy to areas of cardiac tissue to create lesions that interrupt the abnormal electrical signals that contribute to irregular heart rhythms. Irrigated catheters, such as the Therapy Cool Path, are designed to cool the ablation electrode with the intent of reducing some of the risk factors associated with the heat of the RF energy, such as blood coagulation and charring, according to the St. Paul, Minn.-based St. Jude.

The design of the Therapy Cool Flex ablation catheter, which is not FDA approved, features a laser-cut tip, which allows fluid to be infused around the catheter tip electrode, the company said.