Therapeutic and diagnostic devices maker AngioDynamics (ANGO) has won the green signal of the U.S. Food and Drug Administration (“FDA”) for its NeverTouch Direct procedure kit. The new kit has been geared for use with the company’s VenaCure EVLT laser vein treatment.

The NeverTouch Direct provides surgeons the ability to treat varicose veins (abnormally swollen veins) with fewer procedure steps by eliminating the need for a long guide wire or guiding sheath. Varicose veins affect more than 40 million Americans annually. The kit improves patient comfort by mitigating post-operative pain and bruising while maximizing clinical efficacy. AngioDynamics plans to launch the NeverTouch Direct kit in summer 2012.

VenaCure EVLT, which includes DELTA series laser, procedure kits, accessories and a delivery system, continues to be the most preferred laser vein treatment in the market. VenaCure EVLT addresses the high-growth venous intervention market, representing an attractive opportunity for AngioDynamics. The VenaCure franchise continues to grow at a healthy pace in the U.S.

The company expanded its VenaCure EVLT treatment in May 2011 with the launch of the 90 centimeter (cm) NeverTouch kit. The NeverTouch kits are also available in 25 cm, 45 cm and 65 cm lengths.

AngioDynamics, in January 2012, revealed that it expects sales from the NeverTouch fiber systems to increase by roughly $1.1 million in second-half fiscal 2012. This is based on the positive customer response following the resumption of shipments of certain NeverTouch procedure kits used with the VenaCure EVLT system. These kits were recalled due to non-conformances of specific components made by the suppliers.

AngioDynamics has market leadership positions in several of its operating segments including angiographic products and thrombolytic catheters and products. Its product lines face strong challenges from the competitive offerings of its larger rivals such as Boston Scientific (BSX) and C. R. Bard (BCR). We currently have a Neutral rating on AngioDynamics, supported by a short-term Zacks #3 Rank (Hold).

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