FDA Clears Venous Interventional Procedure Kit for Use With VenaCure EVLT
February 16, 2012 — U.S. Food and Drug Administration (FDA) granted 510(k) clearance for AngioDynamics NeverTouch Direct procedure kit for use with the company’s VenaCure EVLT laser vein ablation system. The NeverTouch Direct kit offers physicians the ability to treat varicose veins with fewer procedure steps by eliminating the need for a long guidewire or guiding sheath, while continuing to deliver to patients less pain and bruising compared to bare-tip fibers.
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 NeverTouch Direct kit, expected to launch in summer 2012, is indicated 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, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
For more information: www.angiodynamics.com