the power of water the industry leader in endovascular laser ablation
Contents
1. 4 VenaCureEvLT Endovenous Laser Treatment System THE POWER OF WATER THE INDUSTRY LEADER IN ENDOVASCULAR LASER ABLATION lt gt VenaCureEvLT Endovenous Laser Treatment System F a 12 f m Y C el 8 i ANGIODYNAMKS VenaCure 1470 Laser The Power of water The new VenaCure 1470nm laser from AngioDynamics may result in even better patient outcomes for physician s with all the same features and reliability that made the Delta laser such a success AngioDynamics is not only a pioneer in the laser vein ablation market we re also the world s largest endovenous laser ablation company Venalure Endovenous Laser Treatment System International edition not intended for distribution in the USA Allthe features you love The VenaCure 1470 laser has all the features you love about the Delta laser platform the Fibre Recognition System FRS which facilitates fewer steps enabling a shorter procedure set up the high performance design and the controls and interconnects which were kept to a minimum and carefully placed making the interface simple and easy to use Like the Delta laser the VenaCure 1470 laser helps physicians treat patients with ease Absorption cm 1 Heats the Vein Wall to Ablation Temperature Faster 10000 1000 O 2 0 01 0 001 4 VenaCureEvLT 4 VenaCureEvLT Endovenous Laser Treatment System Endovenous Laser Treatment System T2. Unique colour copmbination increases visisbility in the sterile field Procedure Steps gt VenaCure EVLT Endovenous Laser Treatment System NeverTouch Direct Kit vs NeverTouch Kits Fewer procedure steps may result in a reduction of procedure time gt NeverTouch Direct Procedure Kit Steps Access using micro access Insert fibre place 1 2 cm Activate laser and treat vein gt NeverTouch Procedure Kit Steps Remove guidewire kit and dilator from saphenofemoral junction Exchange for larger wires Advance treatment sheath Remove guidewire and dilator t The above is an abbreviated representation of the steps to reat a vein with the VenaCure EVLT system All the steps necessary to successfully treat a varicose vein have not been included International edition not intended for distribution in the USA 4 gt Venal ure EVLT NeverTouch Direct Procedure Kit Features and Benefits Endovenous Laser Treatment System New procedure kit package designed with physician feedback increases usabillity and functionality A SMA connector 5 p e Separate micro access components packaging reduces waste e Stackable boxes with a smaller package footprint makes storage more efficient Fibre tip J a AngioDynamics lasers Never Touch Direct fibre to increase ease of use and helps maintain a sterile field a Access in the sterile field from either the page SMA connector or fibre t
3. ata on file AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo VenaCure NeverTouch Sheath Lok and Tre Sheath are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary AngioDynamics Inc MLC 492 A4 RevA Covered by U S Patents and related Foreign Patents pending International edition not intended for distribution in the USA
4. chnology is exclusive to AngioDynamics and is different from competitors with other covered tip fibres that have the same power density as a 600 um fibre Bench testing results may not be indicitive of clinical performance All claims based on bench test data on file Testing completed by AngioDynamics International edition not intended for distribution in the USA 4 VenaCureEvLT Endovenous Laser Treatment System The NeverTouch Fibre Can Successfully Treat Larger Veins BEFORE 39 2 mm GSV before 4 VenaCureEvLT Endovenous Laser Treatment System AFTER Vein after Venacure 1470 laser procedure with NeverTouch fibre International edition not intended for distribution in the USA EVLI Select from a variety of micro access kits all packaged on the outside in a separate stone Douch Fiber recognition system is compatible with all AngioDynamics lasers p _ zu a p ale XA ae S S Aids in marking treatment E A length and holding sheathin eee place during tumescent anesthesia Enables precise placement at the saphenofemoral junction by locking the po fiber to the sheath assuring the fiber stays a safe distance outside the sheath translucent radiopaque echogenic Echogenic for easy positioning and New 19 gauge needle now hydrophilic coating to reduce procedure time available for physicians who prefer to insert the 035 wire directly t
5. competence and reflux of superficial veins of the lower extremity VenaCure EVLT 400um PVAK RFID w 21g needle 018 Micro Access Guidewire amp 4F Micro Introducer Sheath with Dilator EVLT PVAK 3 l 5 Bare Tip 400 um Fibre 10 cm 11403101 NeverTouch Direct FRS w 21g needle 018 45 cm nitinol stainless steel wire and AF 10 cm introducer dilator 85cm Fibre 1 AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a minimally invasive choice for gt B IMPORTANT RISK INFORMATION CAUTION This device is ethylene oxide sterilized and intended for single CONTRAINDICATIONS Patients with thrombus in treating the source of their varicose veins and provides INDICATION FOR USE The AngioDynamics Inc VenaCure EVLT patient use only Do not reuse or resterilize the fibres the vein segment to be treated patients with an NeverTouch Procedure Kits are indicated for endovascular Contents sterile in unopened undamaged package Do not use if opened aneurysmal section in the vein segment to be them with quicker recovery and a return to normal daily coagulation of the Great Saphenous Vein GSV in patients or any sign of product damage is visible Carefully read all directions and ed or patients with peer artery disease i i i i with superficial vein reflux for the treatment of varicose veins observe all Warnings and Precautions prior to performing the procedure as determined by the Ankle Brachial Pressure Index routines as compared t
6. energy 500 1000 2000 Lightweight Compact and Portable Wavelength nm e Internal sensors constantly monitor wattage ensuring a constant e Easily transported between hospital and office energy output e More than 20 safety features at and above standard International edition not intended for distribution in the USA International edition not intended for distribution in the USA NeverTouch Gold Tip Fibre 4 VenaCureEvLT 4 VenaCure Endovenous Laser Treatment System Endovenous Laser Treatment System The NeverTouch Gold Tip Fibre The gold tip fibre eliminates inadvertant laser tip contact with the vein wall The gold tip also maximises visibility under ultrasonic visibility making it easier for physicians to use Echogenic International edition not intended for distribution in the USA International edition not intended for distribution in the USA Gold NeverTouch jacket New laser emitting surface size 905 um Fibre Fibre is recessed from tip The Proprietary Science Behind NeverTouch Fibres The innovation behind the NeverTouch fibre is a glass weld at the distal tip of a 600 um fibre The weld results in an effective fibre diameter of 905 um and lowers the actual power density by 56 percent from that of a standard bare tip 600 um fibre The net effect based on bench testing is a homogeneous ablation with less focal charring of the vein wall than that which is seen with bare tip fibres This te
7. eral USA law restricts the sale of this device byor found in the instructions for use supplied with each device Observe all wear protective glasses with the proper rating for fibre tech nology please visit www VenaCure EVLT com on the order of a physician instructions prior to use Failure to do so may result in patient complications the wavelength being used gt VenalureEvLT Endovenous Laser Treatment System amp gt angiodynamics USA gt 603 Queensbury Avenue Queensbury NY 12804 gt tel 800 772 6446 or 518 798 1215 gt fax 518 798 1360 International gt Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O gt The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com References 1 Long Wavelengths Allow Usage Of Less Power And Lower Energy Density Jose I Almeida MD FACS RVT 1 lafrati M Subfascial Endoscopic Perforator Vein Surgery Seminars in Cutaneous Medicine and Surgery 2005 10 007 Elsevier Inc 2 An Update on Endovenous Laser Ablation Update by Mikel Sadek MD Lowell S Kabnick MD 3 EVL Ablation Using jacket Tip Laser Fibres by Lowell S Kabnick MD FACS FACPH and Jayne A Caruso RN 4 Nelzen O Prospective study of safety patient satisfaction and leg ulcer healing following Saphenous and SEPS British Journal of Surgery 2000 87 86 91 5 Barwell J et al ESCHAR Study randomized controlled trial The Lancet June 2004 63 1854 59 t User Manual D
8. he VenaCure 1470nm laser is a water specific laser meaning it damages the intima or inner most layer of the vein by targeting water as the chromophore to absorb the laser energy Since the vein structure is mostly water this laser is able to efficiently heat the vein with little chance of collateral heating resulting in an optimal vein ablation The VenaCure 1470nm laser is designed to work exclusively with AngioDynamics NeverTouch and NeverTouch Direct fibres and perforator ablation kits maximising these Hemoglobin two technologies may result in even better patient outcomes The 1470nm laser allows effective vein ablation with increased efficiency and precisely delivers the targeted energy of 30 50 joules cm through the NeverTouch fibre at a setting of 5 7 watts mar VenaCure 1470 Laser Features amp Benefits O o Fibre Recognition System FRS Easy to use e Faster procedure set up with preset parameters e Intuitive user interface with fewer buttons e Immediate recognition of procedure presets e Programmable sound pulses allows for audible tracking of pull back rate which increases repeatability of treatment e Protective door helps prevent dust particles from damaging laser or fibre e Aiming beam with variable modes and brightness increases visibility in patient Quality e Industry leading standard warranty ensures every laser will receive top notch service e Real time on screen display of treatment
9. heath Introducer with Dilator Distal Tip 600 um Fibre 45cm Standard Kit 11403003 25cm Kit gt NeverTouch FRS w 21g needle and 018 Micro Access Guidewire amp Micro introducer Sheath PLUS amp 035 wire Long access Double NeverTouch FRS w 21g needle 018 Long Access Guidewire and 4F TRE Sheath Introducer with Dilator Distal Tip 600 um Fibre 11403002 l l l l E i i 5 11403012 5 ended Guidewire amp 4F TRE Sheath Introducer with Dilator Distal Tip 600 um Fibre 65cm Standard Kit 45cm Kit NeverTouch FRS w 21g needle and 018 Micro Access Guidewire amp Micro introducer Sheath PLUS 035 wire Long access Double NeverTouch FRS w 21g needle 018 Long Access Guidewire and 4F TRE Sheath Introducer with Dilator Distal Tip 600 um Fibre 11403004 i E E E j i 3 11403013 5 ended Guidewire amp 4F TRE Sheath Introducer with Dilator Distal Tip 600 um Fibre 90cm Standard Kit 65cm Kit PROCEDURE KIT NeverTouch Direct PROCEDURE KIT 400um fibre The NeverTouch Direct Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein GSV in patients with superficial 400um is intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein reflux for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein GSV and for vein and with veins in the lower limbs with superficial reflux the treatment of in
10. hrough the needle Improves pushability through tortuous anatomy and increases echogenicity International edition not intended for distribution in the USA NeverTouch Direct Go Direct Fewer Steps Less Time All the benefits of the NeverTouch fibre International edition not intended for distribution in the USA NeverTouch Direct Fibre e Provides same benefits as the NeverTouch fibre now with an atraumatic tip for sheathless placement gt VenaCure EVLT Endovenous Laser Treatment System e Allows physicians to advance to the saphenofemoral junction without the use of a TRE Sheath introducer in appropriate patients e Allows physicians to gain access advance the fibre and treat a diseased vein without the placement of a second guidewire e Fewer components result in fewer procedure steps and potentially result in faster procedures Markings to 85cm allows for a range of access sizes Fiber length hash marks in 10 cm increments to determine treatment length Depth markings on the shaft of the fibre aid in the controlled withdrawal of the fibre during lasing Access site identifi cation markings indicate when the distal tip of the fiber is approaching the access site International edition not intended for distribution in the USA Atraumatic distal tip is designed to improve trackability and minimize potential tissue trauma during insertion and placement at the saphenofemoral junction
11. ip or both Gold NeverTouch jacket New laser emitting m 2 j h surface size 905 um NeverTouch Fibre recognition system The new fibre management system MN i i i i is compatible with all N i Y Direct Fibre allows for controlled removal of the i ig Fibre with a Blue Nylon Jacket Fibre Fibre is recessed from tip Glass ferrule AF 10cm Nylon Introducer dilator The Proprietary Science Behind NeverTouch Fibres 45 cm 018 nitinol The innovation behind the NeverTouch fibre is a glass weld at the distal tip of a 600 stainless steel wire um fibre The weld results in an effective fibre diameter of 905 um and lowers the The 018 wire tips are atraumatic designed to actual power density by 56 percent from that of a standard bare tip 600 um fibre deflect off The net effect based on bench testing is ahomogeneous ablation with less focal charring of the vein wall than that which is seen with bare tip fibres AngioDynamics patent pending technology is different from competitors with standard covered tip fibres that have the same power density as a 600 um fibre 21G echogenic access needle in Stainless Steel Available for physicians who prefer to insert the NeverTouch Direct wire directly through the needle Bench testing results may not be indicitive of clinical performance All claims based on bench test data on file Testing completed by AngioDynamics International edition not intended for d
12. istribution in the USA International edition not intended for distribution in the USA 400 um Fiber Procedure Kit 4 VenaCureEvLT Endovenous Laser Treatment 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 e 400 um low profile fiber allows for simple access and positioning e Office based procedure using local anesthesia International edition not intended for distribution in the USA EVLI gt VenaCure EVLT gt VenaCure EVLT Endovenous Laser Treatment System Endovenous Laser Treatment System Part Number Description Box Quantity Part Number Description Box Quantity Procedure kits and Laser LASER PROCEDURE KIT VenaCure EVLT Kits amp fibres The 1470 Laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein The NeverTouch Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein GSV in patients with superficial vein and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb reflux for the treatment of varicose veins and varicosities associated with superficial reflux
13. o surgical stripping The VenaCure y and varicosities associated with superficial reflux of the Great POTENTIAL COMPLICATIONS Adverse reactions may include but are not with a value of lt 0 9 should not have their EVLT system includes 1470 nm and 810 nm lasers a choice Saphenous Vein GSV and for the treatment of incompetence limited to vessel perforation thrombosis pulmonary embolism phlebitis varicosities ablated E n a and reflux of superficial veins of the lower extremity This hematoma infection skin pigmentation alteration neovascularization WARNINGS AND PRECAUTIONS Treatment of a vein of procedure kits procedure accessories marketing product should be used only with lasers cleared for use in the paresthesia due to thermal damage of adjacent sensory nerves anesthetic located close to the skin surface may result in skin materials and support and more For more information treatment of varicose veins varicosities with superficial reflux of tumescence non target irradiation vasospasm hemorrhage necrosis skin burn Tissue not targeted for treatment must be pp A i the GSV and in the treatment of incompetent refluxing veinsin burns and pain protected from injury by direct and reflected laser on these products including our proprietary NeverTouch the superficial venous system in the lower limbs Indications contraindications warnings and instructions for use can be energy All persons in the treatment room MUST bar CAUTION Fed
14. of the Great Saphenous Vein GSV and for the treatment of incompetence and reflux of superficial veins of the lower extremity VCURE1470 XX VenaCure EVLT 1470 Laser with Fibre Recognition System FRS and 1 year manufacturer s warranty Accessories included with each laser NeverTouch FRS w 19g needle 035 Long Access Double ended Guidewire and 4F TRE Sheath Introducer with Dialator Distal Tip f nz 600 um Fibre 45cm Kit z STANDARD KIT VenaCure EVLT Kits amp fibres eo ta r eos NeverTouch FRS w 19g needle 035 Long Access Double ended Guidewire and 4F TRE Sheath Introducer with Dialator Distal Ti The NeverTouch Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein GSV in patients with superficial vein 11403006 600 um Fibre 65cm ae a j 5 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 11403007 en de w 19g needle 035 Long Access Double ended Guidewire and 4F TRE Sheath Introducer with Dialator Distal Tip 1 600 um Fibre 90cm Kit 11403001 NeverTouch FRS w 21g needle and 018 Micro access Guidewire amp Micro introducer Sheath PLUS 035 wire Long access Double 5 NeverTouch FRS w 21g needle 018 Long Access Guidewire and AF TRE Sheath Introducer with Dilator Distal Tip 600 um Fibre ended Guidewire 4F TRE S
Download Pdf Manuals
Related Search