AngioDynamics recently received FDA 510(k) clearance for its NeverTouch Direct Procedure Kit that’s used with the VenaCure EVLT Laser Vein Ablation System for treatment of varicose veins.
The new kit simplifies the procedure, taking out the need to use a long guide wire or guiding sheath to deliver laser energy. The product is scheduled for launch this Summer.
From the announcement:
“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.”
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.
Press release: AngioDynamics Receives FDA Clearance for NeverTouch Direct™ Procedure Kit to be Used With the VenaCure EVLT® System