The US Food and Drug Administration has granted 510(k) clearance for AngioDynamics’ NeverTouch Direct™ procedure kit for use with its VenaCure EVLT® laser vein ablation system.
The NeverTouch Direct kit provides clinicians with the ability to treat varicose veins with fewer procedure steps by eliminating the need for a long guide wire or guiding sheath, resulting in faster procedure time.
The VenaCure EVLT varicose vein laser treatment system comprises the new Venacure 1470nm laser and the DELTA 810 laser, a choice of procedure kits, procedure accessories and tumescent delivery system.
The VenaCure EVLT procedure uses a minimally-invasive endovenous laser to treat varicose veins, and is a clinically proven alternative to traditional and painful ligation and stripping surgery.
The NeverTouch Direct kit 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.
AngioDynamics senior vice president and general manager Alan Panzer said, "NeverTouch Direct and the sheathless fibre 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."
"Taken together with the advantages delivered by our new VenaCure 1470 laser, and the new NeverTouch 90cm fibre, AngioDynamics remains the clear choice for clinicians who demand tools that take advantage of their full range of skill and experience," Panzer added.
The NeverTouch prodecure kit is now available in 25cm, 45cm, 65cm and 90cm, and also is available with an .018in access system.
The company intends to launch the NeverTouch Direct kit in summer 2012.
AngioDynamics’ product line includes ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products.