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VNUS to market ClosureFAST catheter
By Elaine Rigoli
Tampa, Fla., Aug. 4 - VNUS Medical Technologies, Inc. has received 510(k) clearance from the Food and Drug Administration to market its ClosureFAST radiofrequency catheter in the United States.
The VNUS ClosureFAST catheter is designed to heat, shrink and occlude refluxing saphenous veins with radiofrequency ablation times of just three to five minutes, according to a news release.
"We are rapidly accumulating clinical experience prior to product launch. To date, the feedback we have received by users of this catheter and by patients who have received a ClosureFAST procedure has been very positive. The preliminary clinical experience produced with the ClosureFAST catheter has been excellent as evidenced by 100% acute success at closing veins with over 70 veins treated. Follow-up ultrasound examinations showed all but one of the treated veins remained closed," president and chief executive officer Brian E. Farley said in the release.
The company expects to launch this product in the United States in the first quarter of 2007.
VNUS provides medical devices and is based in San Jose, Calif.
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