With PMA approval Feb. 6, Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational became the first cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation.

The EZ Steer ThermoCool Navigational catheter is a bi-directional version of the Navistar ThermoCool. Both devices are compatible with 3-D mapping systems that recognize J&J's Carto System magnetic location sensors.

The approval is consistent with the advice of FDA's Circulatory System Devices advisory committee. At its Nov. 20, 2008, meeting, the panel voted 7-0 to recommend that FDA approve Biosense Webster's PMA supplement to add "treatment of drug-refractory atrial fibrillation" to the ThermoCool catheters' label (¹ Also see "FDA Panel Success Puts ThermoCool First In Line For AF Ablation Indication" - Medtech Insight, 24 November, 2008., p. 8).

Biosense Webster's PMA was based on a 167-patient trial comparing pulmonary vein isolation ablation with NaviStar ThermoCool to anti-arrhythmic drug therapy alone. Patients in the study had failed previous regimens of anti-arrhythmic drugs.

In the ablation arm, 53 out of 103 patients completed the nine-month follow-up without another symptomatic atrial fibrillation event, compared to only 9 out of 56 patients in the control arm.

It is the first of what will likely be many approvals for atrial fibrillation ablation devices in the next several years. Medtronic, Boston Scientific, St. Jude Medical and CardioFocus are all seeking the coveted indication for their ablation catheters (² Also see "Medtronic Makes Another Big Play In A-Fib, Purchases Ablation Frontiers" - Medtech Insight, 19 January, 2009., p. 14).

In a release announcing the approval, FDA points out that although atrial fibrillation is a known risk factor for stroke, "there is no conclusive evidence" linking the treatment of symptoms by ablation to a reduction in stroke.

"Therefore, the FDA agrees with the American College of Cardiology, the American Heart Association and the European Society of Cardiology, which recommend that patients at risk for stroke continue to take blood-thinning medications after ablation procedures for atrial fibrillation," the agency says.

Atrial fibrillation affects between 2.3 million and 5.6 million adults in the United States, according to Biosense Webster.

- Reed Miller (re.miller@elsevier.com)

FDA Approves J&J’s Navistar ThermoCool For Atrial Fibrillation Ablation

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