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St. Jude gets FDA approval for catheters to treat irregular heartbeats

The two new irrigated ablation catheters are used to treat cardiac arrhythmia by delivering radio frequency energy to the cardiac tissue.
 

St. Jude Medical announced Monday that the U.S. Food and Drug Administration has approved two new irrigated ablation catheters that are used to treat cardiac arrhythmia. These include the Safire BLU and Therapy Cool Path bi-directional ablation catheters.

The ablation catheters treat irregular heartbeats by delivering radio frequency (RF) energy to the cardiac tissue. The irrigated tips in these models allow infused saline to circulate during therapy delivery, thereby reducing risk factors associated with the heat of RF energy, the company says. The two products also feature bi-directional deflection and a new shaft with increased torque response to aid in precision, control and maneuverability.

The devices are part of St. Jude’s atrial fibrillation group, which accounted for $707,873 in net sales during fiscal year 2010, or about 14 percent of total revenue.

International sales of atrial fibrillation products increased approximately 15 percent constant currency during the fourth quarter, St. Jude executives told analysts in late January. The company expected more growth by launching products already on the market in Europe, including catheters.