Biosense Webster, a Johnson & Johnson company, has reported the Circulatory System Devices panel of the FDA unanimously recommended pre-market approval (PMA) supplement for its NaviStar ThermoCool catheter for the treatment of symptomatic paroxysmal atrial fibrillation (a-fib).
The NaviStar ThermoCool catheter is the first ablation catheter to be recommended by the panel for FDA approval.
“We are pleased with the recommendation for approval and will work closely with the agency to bring this important new option to patients with a-fib,” said Shlomi Nachman, president of the Diamond Bar, Calif.-based Biosense.
The company said the conditions for approval recommended by the review panel include a post-marketing registry and a physician education program about use of the product.
Currently, there are no ablation catheters approved for marketing by the FDA for the treatment of a-fib in the U.S.
Biosense said it has requested expanding the current label for the NaviStar ThermoCool catheter to include an indication for drug refractory symptomatic paroxysmal a-fib. The NaviStar ThermoCool catheter is currently approved in the U.S. for the treatment of type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior MI.