FDA POSTS INFORMATION ON RECENTLY APPROVED NAVISTAR CATHETER

The FDA Sept. 12 posted information on the Navistar ThermoCool deflectable diagnostic/ablation catheter, which the agency approved Aug. 11.

The device is manufactured by Biosense Webster. It is used with related accessories and the Stockert 70 radio-frequency generator to treat recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (heart attack) in adults, the agency said.

VT is a fast heart rhythm that occurs within the lower chambers of the heart (the ventricles). Symptoms of VT include palpitations, shortness of breath or lightheadedness.

The FDA approval letter for the Navistar can be viewed at www.fda.gov/cdrh/pdf4/P040036a.pdf (http://www.fda.gov/cdrh/pdf4/P040036a.pdf).