The US Food and Drug Administration (FDA) has granted 510(k) approval to AngioDynamics' NeverTouch Direct procedure kit for use with the its VenaCure EVLT laser vein ablation system.
The NeverTouch kit is designed for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein.
The kit is also used to treat incompetence and reflux of superficial veins of the lower extremity.
AngioDynamics senior vice president and GM Alan Panzer said NeverTouch Direct and the sheathless fiber option further expands the physician’s ability to tailor treatment to each individual patient, and avoid one-size-fits-all approaches that limit the physician’s ability to exercise their clinical judgment.
The company expects to introduce its NeverTouch Direct kit in summer 2012.