February 13, 2012

FDA Clears AngioDynamics' NeverTouch Direct Kit

February 14, 2012—AngioDynamics, Inc. (Latham, NY) announced that the US Food and Drug Administration has granted 510(k) clearance for the NeverTouch Direct procedure kit for use with the company's VenaCure EVLT (endovascular laser therapy) laser vein ablation system.

According to the company, the NeverTouch Direct kit allows a shorter procedure time for varicose vein therapy by eliminating the need for a long guidewire or guiding sheath while continuing to treat patients with less pain and bruising compared to bare-tip fibers.

 The NeverTouch Direct kit is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremities. AngioDynamics expects to launch the kit in the summer of 2012.

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February 13, 2012

FDA Clears AngioDynamics' NeverTouch Direct Kit

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