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NeverTouch Procedure Kit

NeverTouch® Technology

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

NeverTouch Procedure Kit Components

The NeverTouch Fibre{alt}

Proprietary fibre technology eliminates any inadvertent contact between the fibre tip and vein wall, improving safety and patient comfort. The gold-tipped fibre maximizes visibility under ultrasound.

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

  • Innovative coating technology reduces catheter surface friction by as much as 90 percent
  • Coating reduces overall procedure time by promoting smoother navigation through tortuous vasculature
  • No initial pre-wetting required. The sheath is hydrophilic-coated up to 5 cm from the hub, allowing for smooth navigation as well as optimum handling and control
  • Highly crosslinked polymer chains optimize hydrophilic coating durability by enhancing the stability of the compound
  • Hydrophilic coating is resistant to scratching or abrasion, ensuring reliably smooth navigation throughout the procedure
  • Distinctive centimeter markers allow you to predetermine the treatment length from access site to the saphenofemoral junction (SFJ) for a more accurate pull-back rate
  • Tip markers allow you to see when you are at the tip of the sheath and to determine the treatment endpoint
  • Sheath tip is radiopaque and super-echogenic

Sheath-Lok™ System {alt}

Allows for precise placement of the fibre tip at the SFJ. Locking the fibre to the sheath assures the fibre stays a safe distance outside the sheath, with no need for taping or measuring.

Guidewire {alt}

  • The double-ended .035” guidewire gives you a choice when negotiating torturous veins: Straight tip on one end; J-tip on the other

Sliding Sheath Gauge {alt}

  • Used for marking treatment length, and assisting in holding sheath in place during tumescent anesthesia.

Micro-Access Kit

  • Packaged in a separate, sterilized kangaroo pouch
  • 21-gauge, 7cm, super-sharp echogenic tip needle
  • .018” x 45cm nitinol guidewire with stainless steel tip
  • 5F x 10cm sheath and dilator

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 fibres or re-sterilize the fibres.

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