NeverTouch Procedure Kit

NeverTouch® Technology

The new NeverTouch^® gold-tipped laser fiber, an integral part of AngioDynamics’ advanced varicose vein treatment, establishes a new standard for patient comfort and visibility. The innovation behind the NeverTouch tip is a glass weld at the distal tip of a 600um fiber. This weld results in an effective fiber diameter of 905ums and lowers the actual power density at the tip by 56% from that of a standard bare-tip 600um fiber. The net effect is a homogeneous ablation with less focal charring of the vein wall that is typically seen with bare-tip fibers. This technology also differentiates from competitors with other covered-tip fibers that have the same power density as a 600um fiber. The proprietary technology, which became CE Marked in 2008, maximizes tip visibility under ultrasound and eliminates chances of inadvertent fiber tip contact with the vein wall, further improving safety and patient comfort.

NeverTouch Procedure Kit Components

NeverTouch-FRS Fiber

• Proprietary fiber technology eliminates any inadvertent contact between the fiber tip and vein wall, improving safety and patient comfort. The gold-tipped fiber maximizes visibility under ultrasound.
• Fiber recognition system is compatible with all AngioDynamics’ lasers
• Available in 25cm, 45cm, 65cm and 90cm procedure kits
   

4F Trè-Sheath® Introducer featuring our Duration™ Coating Technology (translucent - radiopaque - echogenic)

• Echogenic for easy positioning and hydrophilic coating to reduce procedure time

Sheath-Lok™ System

• Enables precise placement at the saphenofemoral junction by locking the fiber to the sheath, assuring the fiber stays a safe distance outside the sheath

Double-ended .035" Guidewire

• Straight-tip and J-tip ends give you a choice when navigating tortuous veins

Sliding Sheath Gauge

• Aids in marking treatment length and holding sheath in place during tumescent anesthesia

Available with an .018" System

• New .018” system eliminates the need for a 5F micro-access sheath and to exchange wires and size up, resulting in fewer procedure steps, and a faster procedure time

Available with a 21 or 19 gauge needle

• New 19 gauge needle now available for physicians who prefer to insert the .035” wire directly through the needle

Convenient “kangaroo pouch” packaging

• Micro-access kit packaged on the outside in a separate sterile pouch

Micro-Access Kit

• 21-gauge, 7cm, super-sharp echogenic tip needle
• .018" x 45cm nitinol guidewire with stainless steel tip
• 5F x 10cm sheath and dilator

AngioDynamics offers several micro-access systems to satisfy a variety of clinical needs. The chart below specifies the kit options and components that accompany the NeverTouch gold-tip fiber.

Refer to full Instructions for Use on how to use this medical device.

INDICATION FOR USE:
The AngioDynamics, Inc. VenaCure EVLT™ NeverTouch® - FRS Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The VenaCure EVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.
Exclusions:
Patients with thrombus in the vein segment to be treated
Patients with an aneurysmal section in the vein segment to be treated
Patients with peripheral artery disease as determined by an Ankle- Brachial Index <0.9

SAFETY PRECAUTION:
ALL PERSONS IN THE TREATMENT ROOM MUST BE WEARING PROTECTIVE GLASSES WITH THE PROPER RATING FOR THE WAVELENGTH BEING USED.

POTENTIAL COMPLICATIONS:
The potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.

WARNINGS:
Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not re-use the fibers or re-sterilize the fibers.

PRECAUTIONS:
Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a diameter of 20 cm. Clinical safety and effectiveness data is not available for other fiber tip designs and diameters. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage.