NeverTouch Direct Procedure Kit
Go Direct: Less steps. Less time.
All the benefits of the NeverTouch* fiber with a shorter procedure time
- Provides same benefits as the NeverTouch Fiber, now with an atraumatic tip for sheathless placement
- Allows physicians to advance to the saphenofemoral junction without the use of a TRE-Sheath introducer in appropriate patients
- Allows physicians to gain access, advance the fiber and treat a diseased vein without the placement of a second guidewire
- Results in faster procedures and fewer components
New Package Kit Design
New package designed with physician feedback increases usability and functionality:
- The new fiber management system allows for controlled removal of the fiber to increase ease of use and helps maintain a sterile fieldSeparate micro-access components packaging reduces waste
- Stackable boxes with a smaller package footprint makes storage more efficient
- Access in the sterile field from either the SMA connector or fiber tip, or both
INDICATION FOR USE:
The AngioDynamics, Inc. VenaCure EVLT NeverTouch Procedure Kits are 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. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.
Federal (USA) law restricts the sale of this device by or on the order of a physician.
Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated.
WARNINGS AND PRECAUTIONS:
Treatment of a vein located close to the skin surface may result in skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy. All persons in the treatment room MUST wear protective glasses with the proper rating for the wavelength
This device is ethylene oxide sterilized and intended for single patient use only. Do not reuse or resterilize the fibers. Contents sterile in unopened, undamaged package. Do not use if opened or any
sign of product damage is visible. Carefully read all directions and observe all Warnings and Precautions prior to performing the procedure.
Adverse reactions may include, but are not limited to: 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.
Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.