Risk Information & Trademarks
VENACURE EVLT 1470 PRO LASER INDICATION 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. 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. VENACURE EVLT NEVERTOUCH, NEVERTOUCH DIRECT, AND PROCEDURE KIT 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. 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. VENACURE EVLT 400 μm PERFORATOR AND ACCESSORY VEIN ABLATION KIT 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) 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 For a complete list of Warnings, Precautions, and Potential Complications refer to the Instructions for Use package insert provided with the product. *AngioDynamics, the AngioDynamics logo, VenaCure EVLT, VenaCure EVLT logo, NeverTouch, NeverTouch Direct, the VenaCure Direct logo, Tre-Sheath, the VenaCure Gold logo, VenaCure 1470 PRO logo, and the VenaCure PVAK logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. US/VI/MS/438 Rev 01 10/2020
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400 Micron Perforator and Accessory Vein Ablation Kit (PVAK)
Explore the SeCure Study
Learn about our Products
RISK INFORMATION VENACURE EVLT 1470 PRO LASER INDICATION 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. 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. VENACURE EVLT NEVERTOUCH, NEVERTOUCH DIRECT, AND PROCEDURE KIT 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. 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. VENACURE EVLT 400 μm PERFORATOR AND ACCESSORY VEIN ABLATION KIT 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) 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 For a complete list of Warnings, Precautions, and Potential Complications refer to the Instructions for Use package insert provided with the product. *AngioDynamics, the AngioDynamics logo, VenaCure EVLT, VenaCure EVLT logo, NeverTouch, NeverTouch Direct, the VenaCure Direct logo, Tre-Sheath, the VenaCure Gold logo, VenaCure 1470 PRO logo, and the VenaCure PVAK logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. US/VI/MS/438 Rev 01 10/2020
Background Information
About the SeCure Study
Key Takeaways*
of the 400 μm Perforator and Accessory Vein Ablation Kit (indication below)
Trial led to the FDA clearance
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).
The VenaCure EVLT
of pathological perforator veins with improvement in the patient's quality of life
The trial demonstrated successful ablation
in December of 2018
SeCure trial was successfully completed
Purpose: To evaluate the safety and effectiveness of the 400 Micron Perforator and Accessory Vein Ablation Kit for the treatment of Incompetent Perforator Veins (IPVs).
Primary endpoints were: "Acute Primary Ablation Success," or the complete lack of flow or IPV disappearance in the entire treated segment, as measured via duplex ultrasound imaging performed 10 days (+/- 3 days) post procedure.
Secondary endpoints were: technical success, 1, 3, 6, 9, 12-month primary ablation closure rates; changes in Venous Clinical Severity Score (VCSS), quality of life, ulcer healing, and adverse events.
in the SeCure Study
83 Patients
Exhibited CEAP 4b, 5, and 6 classification
of the SeCure Study
Characteristics
- Single-arm - Prospective - Multi-center - Non-blinded
1
2
3
4
is prevalent worldwide and venous ulcers are a manifestation of venous insufficiency
Chronic Venous Insufficiency (CVI)
imposes an enormous cost to health care systems
Venous Disease
have been associated with Venous Ulceration
Incompetent Perforator Veins (IPVs)
have active venous ulcers and a history of venous ulcers that have healed
Between 1% and 2.7% of the population
1. Olin JW, et al. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999; 4(1): 1-7. 2. Dillavou ED, et al. Current state of the treatment of perforating veins. J Vasc Surg Venous Lymphat Disord. 2016 Jan; 4(1):131-5. 3. Kiguchi MM, et al. Factors That Influence Perforator Thrombosis and Predict Healing: Perforator Sclerotherapy for Venous Ulceration Without Axial Reflux. J Vasc Surg Venous Lymphat Disord. 2015 Jan; 3(1):125. 4. Meissner MH, et al. Primary Chronic venous disorders. J Vasc Surg. 2007; 46 (Suppl S): 54S-67S.
Explore the Premise of the Study
Review the Key Takeaways of the Study
RISK INFORMATION 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: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. Treatent of a vein located close to the skin surface may result in a 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 any person present in the operating room. Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm. The positions of the Site Marks on the EVLT fiber have been matched to the introducer sheath provided in the VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit. Alternative sheaths must not be substituted. Do not tighten the compression clamp on sheath until fiber is in position. Laser protective eye wear must be worn by everyone in the treatment room including the patient. 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. *AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary. © 2020 AngioDynamics, Inc. US/VI/TS/439 Rev 02 10/2020
*The SeCure study data was presented and discussed at the ACP meeting (6-8 November, Nashville, TN); VEITH symposium (13–17 November, New York, USA) and the IVC meeting (2-4 April, Miami, FL)
Feel SeCure in Your Decision to Treat Perforator Veins
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References
1. Olin JW, et al. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999; 4(1): 1-7. 2. Kiguchi MM, et al. Factors That Influence Perforator Thrombosis and Predict Healing: Perforator Sclerotherapy for Venous Ulceration Without Axial Reflux. J Vasc Surg Venous Lymphat Disord. 2015 Jan; 3(1):125. 3. Dillavou ED, et al. Current state of the treatment of perforating veins. J Vasc Surg Venous Lymphat Disord. 2016 Jan; 4(1):131-5. 4. Meissner MH, et al. Primary Chronic venous disorders. J Vasc Surg. 2007; 46 (Suppl S): 54S-67S. 5. Gibson K, Elias S, Adelman M, et al. A prospective safety and effectiveness study using endovenous laser ablation with a 400-μm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial). J Vasc Surg Venous Lymphat Disord. 2020;8(5):805-813. doi:10.1016/j.jvsv.2020.01.014
4. Meissner MH, et al. Primary Chronic venous disorders. J Vasc Surg. 2007; 46 (Suppl S): 54S-67S. 5. Gibson K, et al. A Prospective Safety and Effectiveness Study using the endovenous laser ablation technique with a 400 μm optical fiber (SeCure trial). Presented at: American College of Phlebology meeting. 2018 Nov 8; Nashville, TN. 6. Adelman M et al. The SECURE Trial: Update on Perforator Ablation (Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT). Presented at: VEITH meeting. 2018 Nov 15; New York, NY.
5
Key Takeaways
SeCure Trial was successfully completed
83 patients
REFERENCES 1. Olin JW, et al. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999; 4(1): 1-7. 2. Kiguchi MM, et al. Factors That Influence Perforator Thrombosis and Predict Healing: Perforator Sclerotherapy for Venous Ulceration Without Axial Reflux. J Vasc Surg Venous Lymphat Disord. 2015 Jan; 3(1):125. 3. Dillavou ED, et al. Current state of the treatment of perforating veins. J Vasc Surg Venous Lymphat Disord. 2016 Jan; 4(1):131-5. 4. Meissner MH, et al. Primary Chronic venous disorders. J Vasc Surg. 2007; 46 (Suppl S): 54S-67S. 5. Gibson K, Elias S, Adelman M, et al. A prospective safety and effectiveness study using endovenous laser ablation with a 400-μm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial). J Vasc Surg Venous Lymphat Disord. 2020;8(5):805-813. doi:10.1016/j.jvsv.2020.01.014
Treat Incompetent Perforator Veins With Precision
the importance of treating perforator veins
400 micron Perforator Vein ablation kit (PVAK)
You can treat Incompetent Perforator Veins (IPVs) with precision, thanks to the 400 micron Perforator & Accessory Vein Ablation Kit from AngioDynamics
.018” guidewire navigates small, tortuous veins with a floppy tip and has a firm anchor to guide the sheath and hold it in place.
Smaller sized fiber aids in Saphenous Vein (SV) access and positioning.
21G venous access needle ensures easy, atraumatic access.
Incompetent Perforator Veins (IPVs) associated with Chronic Venous Insufficiency (CVI) are linked to venous hypertension, severe sequelae of CVI, and the development of leg ulcers. Treatment of IPV and CVI can lead to reduced recurrent rates for venous ulcers. This represents a significant opportunity to expand the range of venous disease treatment for your patients and your practice. The 400 Micron PVAK Kit’s low-profile fiber allows for simple access and easy positioning.
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1. Gohel, M., Heatley, F., Liu, X., Bradbury, A., Bulbulia, R., Cullum, N., Epstein, D., Nyamekye, I., Poskitt, K., Renton, S., Warwick, J. and Davies, A. (2018). A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. New England Journal of Medicine, 378(22), pp.2105-2114.1. 2. Barwell J, Davies C, Deacon J. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomized controlled trial. ACC Current Journal Review. 2004;13(8):23-24. doi:10.1016/j.accreview.2004.07.117.
Early endovenous ablation of superficial venous reflux has been shown to result in faster healing of venous leg ulcers
Venous disease is the most common cause of leg ulceration
RISK INFORMATION 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: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. Treatent of a vein located close to the skin surface may result in a 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 any person present in the operating room. Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm. The positions of the Site Marks on the EVLT fiber have been matched to the introducer sheath provided in the VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit. Alternative sheaths must not be substituted. Do not tighten the compression clamp on sheath until fiber is in position. Laser protective eye wear must be worn by everyone in the treatment room including the patient. 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. *AngioDynamics and the VenaCure PVAK logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. US/VI/TS/441 Rev 01 10/2020
Importance of treating perforator veins
The 400 micron Perforator Vein ablation kit (PVAK)
REFERENCES 1. Gohel, M., Heatley, F., Liu, X., Bradbury, A., Bulbulia, R., Cullum, N., Epstein, D., Nyamekye, I., Poskitt, K., Renton, S., Warwick, J. and Davies, A. (2018). A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. New England Journal of Medicine, 378(22), pp.2105-2114.1. 2. Barwell J, Davies C, Deacon J. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomized controlled trial. ACC Current Journal Review. 2004;13(8):23-24. doi:10.1016/j.accreview.2004.07.117.
RISK INFORMATION VENACURE EVLT 1470 PRO LASER INDICATION 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. 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. VENACURE EVLT NEVERTOUCH, NEVERTOUCH DIRECT, AND PROCEDURE KIT 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. 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. VENACURE EVLT 400 μm PERFORATOR AND ACCESSORY VEIN ABLATION KIT 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) 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 For a complete list of Warnings, Precautions, and Potential Complications refer to the Instructions for Use package insert provided with the product. *AngioDynamics, the AngioDynamics logo, VenaCure EVLT, VenaCure EVLT logo, NeverTouch, NeverTouch Direct, the VenaCure Direct logo, Tre-Sheath, the VenaCure Gold logo, VenaCure 1470 PRO logo, and the VenaCure PVAK logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2020 AngioDynamics, Inc. US/VI/TS/442 Rev 01 10/2020
Designed to work exclusively with the range of AngioDynamics fibers, including the NeverTouch* fibers. Maximizing these two technologies can result in even better patient outcomes.
The 1470 nm laser allows effective vein ablation with the targeted energy of 30-50 joules/cm at a setting of 5-7 watts.
Intuitive touch screen controls and streamlined form.
Programmable settings, tailored treatment parameters, and custom user profiles.
Real-time procedure feedback.
Aiming beam with variable modes and brightness to increase visibility in patient.
VenaCure EVLT 1470 Pro Laser
The latest iteration of our high-performing diode laser, the VenaCure 1470 Pro laser offers enhanced functionality and an improved user interface as compared to other 1470 lasers. As a water-specific laser, the VenaCure 1470 Pro laser targets water as the chromophore to absorb the laser energy. Since the vein structure is mostly water, it is theorized that the 1470 nm laser wavelength efficiently heats endothelial cells with a low risk of collateral damage, resulting in optimal vein ablation.
400 Micron Perforator and Accessory Vein Ablation Kit
Barwell J, Davies C, Deacon J. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomized controlled trial. ACC Current Journal Review. 2004;13(8):23-24. doi:10.1016/j.accreview.2004.07.117.
Innovative design eliminates laser tip contact with the vein wall, minimizing damage to the wall as compared to traditional bare-tip fibers.
Gold-tip maximizes ultrasonic visibility, thereby making it easier for physicians to use.
NeverTouch Gold-Tip Fiber Procedure Kits
Use of a 1470 nm laser wavelength in conjunction with jacket-tip fibers, such as our NeverTouch gold-tip laser fiber (exclusive to AngioDynamics), is the greatest contributing factor in minimizing pain and bruising while enhancing visibility and therefore ease of use.
Gold NeverTouch jacket
Laser-emitting surface size 905 um with a glass ferrule
NeverTouch Direct Procedure Kits
The NeverTouch Direct Fiber includes an atraumatic tip for sheathless placement, which allows physicians to advance to the saphenofemoral junction in appropriate patients without the use of a TRE-Sheath Introducer. In addition to the benefits of the NeverTouch Gold-Tip Fiber, the NeverTouch Direct Procedure Kit allows physicians to gain access, advance the fiber, and treat a diseased vein without the placement of a second guidewire.
Learn About Our Performance Driven Products
REFERENCES 1. Kabnick LS, Sadek M. Fiber type as compared to wavelength may contribute more to improving postoperative recovery following endovenous laser ablation. J Vasc Surg Venous Lymphat Disord. 2016;4(3):286-292. doi:10.1016/j.jvsv.2015.12.004 2. Barwell J, Davies C, Deacon J. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomized controlled trial. ACC Current Journal Review. 2004;13(8):23-24. doi:10.1016/j.accreview.2004.07.117
vENAcURE evlt 1470 pRO lASER
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