The US Food and Drug Administration FDA has granted 510(k) clearance to AngioDynamics to market its NeverTouch Direct Procedure Kit for use with the VenaCure EVLT Laser Vein Ablation System (AngioDynamics).
The NeverTouch Direct offers physicians the ability to treat varicose veins with fewer procedure steps‰Û¥by eliminating the need for a long guide wire or guiding sheath‰Û¥while continuing to deliver to patients less pain and bruising compared to bare-tip fibers.
The NeverTouch Direct, 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.
“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,” said Alan Panzer, senior vice president and general manager, AngioDynamics.
