400 um Fiber Kit
Treat Superficial Veins with the Precision of the VenaCure EVLT System
Superficial Veins (SV) associated with Chronic Venous Insufficiency (CVI) are linked to venous hypertension, severe sequelae of CVI, and the development of leg ulcers. Treatment of CVI/SV can lead to reduced recurrence rates for venous ulcers. This represents a significant opportunity to expand the range of venous disease treated in your practice.
Treat SV with the 400 μm Fiber Procedure Kit, part of the VenaCure EVLT system:
- 400 μm low-profile fiber allows for simple access and positioning
- Less pain, discomfort and potential complications compared to traditional surgery (Linton Technique) or subfascial endoscopic methods
- Office-based procedure using local anesthesia
Features & Benefits
- 400 um Optical Fiber - Smaller sized fiber aids in SV access and positioning
- 21G Venous Access Needle - Ensures easy, atraumatic access
- 10 cm x 4F Introducer Sheath - Stiff dilator guides the sheath into the proper subfascial plane
- Hub and Compression Clamp - Hub on sheath mates with compression clamp on fiber
- .018” Guidewire - Navigates small, tortuous veins with a floppy tip and has a firm anchor to guide sheath and hold it in place
- Site Marks on Fiber - Site marks match to sheath to ensure proper positioning
Refer to full Instructions for Use on how to use this medical device.
INDICATION FOR USE:
AngioDynamics Laser and VenaCure EVLT Procedure Kits with the 400 μm Fiber are indicated for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the great saphenous vein, and with veins in the lower limbs with superficial reflux. The D15 Plus, D30 Plus, Delta-15 and Delta-30 lasers and VenaCure EVLT Kits are indicated for treatment of incompetent refluxing veins in the superficial venous system.
Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; aneurysmal section in the vein segment to be treated; peripheral artery disease as determined by Ankle Brachial Pressure Index with a value of <0.9; an inability to ambulate; deep vein thrombosis; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.
WARNINGS AND PRECAUTIONS:
Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using the VenaCure EVLT Procedure Kits with the 400 μm Fiber. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications. Laser protective eyewear must be worn by everyone in the treatment room, including the patient.
Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. The VenaCure EVLT Procedure Kit is intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates are still valid. Treatment of a vein located close to the skin surface may result in a skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy.
Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis.
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.