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Indications for Use: The VenaCure 1470 Pro laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
Contraindications: Contraindications include but are not limited to the following, 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 arterial disease as determined by an Ankle-Brachial Index < 0.9.
Warnings:
Potential Complications:
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, hemorrhage, necrosis, DEHP exposure, skin burns and pain.
Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use: The VenaCure EVLT 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
Contraindications: Contraindications include but are not limited to the following, 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 arterial disease as determined by an Ankle-Brachial Index < 0.9.
Warnings:
Potential Complications:
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, hemorrhage, necrosis, DEHP exposure, skin burns and pain.
Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use: The VenaCure EVLT NeverTouch Procedure Kits, VenaCure EVLT NeverTouch Direct Procedure Kits and the VenaCure EVLT Tre’ Sheath 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 extremities.
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.
Contraindications: Contraindications include but are not limited to the following, 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 arterial disease as determined by an Ankle-Brachial Index < 0.9.
Warnings:
Potential Complications:
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, hemorrhage, necrosis, skin burns and pain.
Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.
The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).
Contraindications: Contraindications include but are not limited to the following, 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 arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.
Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).
Warnings:
Adverse Events:
Potential complications include, but are not limited to the following: DEHP Exposure, Deep Venous Thrombus, Hematoma, Hemorrhage, Infection, Necrosis, Neovascularization, Non-Target Irradiation, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns and Pain, Infection, Skin Pigmentation Alteration, Thrombophlebitis, Thrombosis, and Vessel Perforation.
Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use: The VenaCure EVLT OPS Procedure Kits are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
Contraindications: Contraindications include but are not limited to the following, 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 arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.
Warnings:
Adverse Events:
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
CAUTION: Federal (USA) law restricts the sale of these devices by or on the order of a physician.
© 2019 AngioDynamics | All Rights Reserved | ANGM 1027 US Rev 01 05/19
*AngioDynamics, the AngioDynamics logo, VenaCure EVLT, the VenaCure EVLT logo, VenaCure, NeverTouch, NeverTouch Direct, the NeverTouch Direct logo, Spotlight OPS, the Spotlight OPS logo, TRE-Sheath, EVLT, VenaCure 1470 Pro, and the VenaCure 1470 Pro logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary.