No Long Guidewire, Less Bruising: FDA Clearance for AngioDynamics NeverTouch Direct™Procedure Kit For Use With the VenaCure EVLT® System

In short

AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the U.S. Food and Drug Administration has granted 510(k) clearance for its NeverTouch Direct™ Procedure Kit for use with the Company’s VenaCure EVLT® Laser Vein Ablation System.

Background

The NeverTouch Direct kit offers physicians the ability to treat varicose veins with fewer procedure steps by eliminating the need for a long guide wire or guiding sheath. The system reduces pain and bruising compared to bare-tip fibers.

The 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.

Company comments

“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 for AngioDynamics. “Taken together with the advantages delivered by our new VenaCure® 1470 laser, and the new NeverTouch® 90cm fiber, AngioDynamics remains the clear choice for clinicians who demand tools that take advantage of their full range of skill and experience.”

Source: AngioDynamics