Johnson & Johnson company receives FDA approval for automated ablation system for heart condition

By Lisa Kerner

Charlotte, N.C., Aug. 22 - The Food and Drug Administration granted an expanded indication to Johnson & Johnson company Biosense Webster, Inc.'s first automated ablation system supporting an open-loop irrigated catheter.

The system incorporates the NaviStar ThermoCool Irrigated Tip Catheter and CoolFlow Pump from Biosense with the Stockert 70 RF Generator, according to a company news release.

The NaviStar ThermoCool Catheter is available for treatment-experienced adults with Ventricular Tachycardia, specific rapid heartbeats following a heart attack.

According to Biosense, the expanded indication provides cardiac electrophysiologists with a new treatment option for the estimated 3 million people in the United States who live with the heart rhythm condition.

"The expanded indication for the NaviStar ThermoCool Irrigated Tip Catheter, with its fully integrated ablation system, gives physicians another important option for treating patients with this potentially dangerous condition," Biosense president Roy Tanaka said in a news release.

The ThermoCool Catheter is also available to treat atrial flutter, a common rapid heart rhythm that arises in the upper chambers of the heart.

Biosense, located in Diamond Bar, Calif., provides advanced diagnostic, therapeutic and mapping tools.

Located in New Brunswick, N.J., Johnson & Johnson manufactures and sells a variety of health care products.

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