VenaCure EVLT Info Kit
Contents
1. CAUTION Federal USA law restricts the sale of this device by or on the order of a physician 201 AngioDynamics Inc MLC 392 US Rev D 3 13 o angiodynamics USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 431 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com AngioDynamics the AngioDynamics logo VenaCure EVLT and the VenaCure EVLT logo are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary CAUTION Federal USA law restricts these devices to sale by or on the order of a physician 2012 AngioDynamics Inc MLC 271 US Rev D 09 122. With superior echogenicity the smooth and soft atraumatic tip is less traumatic upon insertion and during venous navigation 3 Color coded Lengths Color coding provides easy length identification and mating to laser fibers Clearly Numbered Sheath Markings Increased safety with clear indication of distance to end and enhanced ability to measure progress Entry Point Marker Easy marking of initial depth of sheath insertion for quick assessment of treated vein length SPOTLIGHT ONE PIECE SHEATH PROCEDURE KITS Ergonomic Hub Simple twist and click hub provides ease of use when securing fiber and creating hemostatic seal Double ended 035 Guidewire Straight tip and J tip ends give you a choice when navigating tortuous veins Gripper with RFID Chip Easy connection to laser and embedded chip transfers key fiber data to laser Improved Packaging Configuration Components for access and therapy in a separate sterile package means less waste if unable to access and a smaller footprint equals easier storage AngioDynamics Delta lasers only Description Part Kit Length Procedure Kit with Spotlight OPS Sheath EVLT 25 OPS 25 Procedure Kit with Spotlight OPS Sheath EVLT 55 OPS 55 cm Procedure Kit with Spotlight OPS Sheath EVLT 80 OPS 80 cm AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provide
3. fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com eyewear must be worn by everyone in the treatment room including the patient 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 POTENTIAL COMPLICATIONS 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 AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo and NeverTouch are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary May be covered by or for use under one or more of the following U S patents 5 714 360 6 986 766 7 033 347 7 483 457 7 559 329 7 907 643 other U S patents and foreign counterparts pending 2013 AngioDynamics Inc MLC 247 US Rev F 08 13 Procedure Kits 4 VenaCureEvLT Endovenous Laser Tre
4. 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 being used CAUTION This device is ethylene oxide sterilized and intended for single patient use only Do not reuse or USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com 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 POTENTIAL COMPLICATIONS Adverse reactions may include but are not limited to vessel perforation thrombosis pulmonary embolism phlebitis hematoma infection skin pigmentation alteration neovascularization paresthesia due to therma
5. Endera Laser System E rme orm Pu ma F mo milan Aeee anm m munak vernos mmm aiu in min am 4 ps ee eR ubera runanata tra Gig as rr para LEID ana erleri a AngioDynamics is committed to increasing awareness td MI of venous disease and to driving patients directly to our customer s doors The MVP marketing support program and VenaCure EVLT website help our customers learn about the procedure perform it market their practices and get patient referrals and it s all included for regular users of our laser and procedure kits AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com o angiodynamics USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com Ang
6. In Service e On site visit by AngioDynamics Clinical Specialist e First day case support and training e Online interactive laser simulator si ka EXCELLENCE Peer to Peer Clinical Education Series o angiodynamics Interactive Physician Education Course AngioDynamics two day Physician Education Course which includes interactive and didactic learning and viewing live cases educates physicians about the disease state VenaCure EVLT procedure and adjunctive procedures Regional courses give physicians access to experts in the field while allowing them to be out of their practice for a minimal amount of time Learning Objectives Upon completion of the Physician Education Course attendees should be familiar with Course Topics Treatment Techniques e The patho physiology of superficial venous disease e Endovenous laser ablation including room setup and laser safety e Anatomy and physiology of superficial venous disease e Modified tumescent anesthesia e Indications and diagnosis of superficial venous disease e Phlebectomy e Treatment options for superficial venous disease e Sclerotherapy e Billing and reimbursement for the treatment of superficial e Diagnostic superficial venous ultrasound venous disease e Ultrasound guided anesthesia e AngioDynamics MVP marketing support program for tMaximizing VenaCure EVLT Potential Educational Opportunities AngioDynamics physician education program is offered across the cou
7. The MVP Program provides all the marketing tools and support needed for Maximizing VenaCure EVLT Potential It consists of a wide range of ready to use materials and customized targeted marketing tools for regular users of the VenaCure EVLT system The VenaCure EVLT website at http VenaCure EVLT com educates potential patients about the disease state treatment options and helps them locate a physician in their area who performs the VenaCure EVLT procedure Physicians can learn about the VenaCure EVLT system and use it as a resource to market their practice and will receive leads from patients in their area trying to find a doctor MVP Marketing Support Program Maximizing VenaCure EVLT Potential AngioDynamics MVP marketing support program consists of a wide range of ready to use materials and customizable targeted marketing tools for regular batur users of VenaCure EVLT procedure kits and includes personalized advice to determine which elements will work best for a specific practice The MVP Starter Kit includes e Program overview e Disease state and treatment options education Customized tools include e Procedure tutorial e Multiple templates for print advertising e Practice development information and documents e Exam room posters e Front office training and forms e Customized promotional posters e Marketing tutorial e Registration on VenaCure EVLT com Physician Locator e Patient brochures to gene
8. 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 AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo VenaCure and NeverTouch are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or subsidiary May be covered by or for use under one or more of the following U S patents 5 714 360 6 986 766 7 033 347 7 483 457 7 559 329 7 907 643 other U S patents and foreign counterparts pending 2012 AngioDynamics Inc MLC 412 US Rev C 09 12 4 VenaCureEvLT Endovenous Laser Treatment System A ei a alir ii 28 m rud utu ERN mr ri MIO anaa __ 1 e eyi rai Tana PAO aaa a Eara tee fare TTET I N prani e ie ari a aTa E ya pie DAT mois ee eti re a tute b 2 40 MED ee O ANGIODYNAMICS Delta 810 nm Diode Laser o angiodynamics The original solid state diode laser that started the VenaCure System is reliable and proven technology that makes treating varicose veins easy AngioDynamics is not only a pioneer in the laser vein ablation market we re also the
9. 018 21 gauge NeverTouch FRS Kit 11403013 65 cm 018 21 gauge AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com IMPORTANT RISK INFORMATION 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 CAUTION Federal USA law restricts the sale of this device by or on the order of a physician o angiodynamics CONTRAINDICATIONS Patients with thrombus in the vein
10. 4 VenaCure EVLT eatment System o angiodynamics Diode Lasers 4 VenaCure EVLT Endovenous Laser Treatment System VenaCure venature 1470 1470 6 ASCI PN 12W r Q 6 m i e h AN JOD YNAMICS gt VenaCure 1470 Laser THE POWER OF WATER o angiodynamics The new 1470 nm laser from AngioDynamics offers physicians better patient results 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 Better Outcomes The VenaCure 1470 nm laser is a water specific laser targeting 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 is able to efficiently heat the vein endothelial cells with little chance of collateral damage resulting in an optimal vein ablation The VenaCure 1470 nm laser is designed to work Heats the Vein Wall to Ablation Temperature Faster exclusively with AngioDynamics NeverTouch fibers maximizing these two technologies may result in even 10000 I better patient outcomes The 1470 nm laser allows 1008 effective vein ablation with the targeted energy of Hemeglevin 30 50 joules cm at a setting of 5 7 watts 100 e 5 10 All the Fe
11. T s pregnant or breast feeding or patients in general poor health Other contraindications may be raised by the individual physician at the time of treatment o angiodynamics WARNINGS AND PRECAUTIONS Read the Instructions For Use and the Laser Operator s manual thoroughly prior to using VenaCure EVLT procedure kits Observe all warnings precautions and cautions noted Failure to do so may result in patient complications CAUTION Intended for use only by fully trained physicians Federal USA law restricts these devices to sale by or on the order of a physician VenaCure EVLT procedure kits are 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 on the VenaCure EVLT procedure kits are still valid Laser protective eyewear must be worn by everyone in the treatment USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com room including the patient Treatment of a vein located close to the skin surface may result in a skin burn POTENTIAL COMPLICATIONS Adverse reactions may include but are not limited to vessel perforation thrombosis pulmonary embolism phlebitis
12. VenaCure EVLT com IMPORTANT RISK INFORMATION INDICATION FOR USE AngioDynamics 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 in the lower limb CONTRAINDICATIONS Patients should not have their varicosities ablated who have the following conditions thrombus in the vein segment to be treated an inability to ambulate severe arterial disease deep vein thrombosis or those with a history of DVT s pregnant or breast feeding or patients in general poor health Other contraindications may be raised by the individual physician at the time of treatment o angiodynamics WARNINGS AND PRECAUTIONS Read the Instructions For Use and the Laser Operator s manual thoroughly prior to using VenaCure EVLT procedure kits Observe all warnings precautions and cautions noted Failure to do so may result in patient complications CAUTION Intended for use only by fully trained physicians Federal USA law restricts these devices to sale by or on the order of a physician VenaCure EVLT procedure kits are 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 on the VenaCure EVLT procedure kits are still valid Laser protective USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215
13. atment System NeverTouch Direct PROCEDURE KIT o angiodynamics Go Direct Less steps Less time All the benefits of the NeverTouch fiber with a shorter procedure time NeverTouch Direct Fiber e Provides same benefits as the NeverTouch fiber now with an atraumatic tip for sheathless placement e Allows physicians to advance to the saphenofemoral junction without the use of TRE Sheath introducer in appropriate patients e Allows physicians to gain access advance the fiber and treat a diseased vein without the placement of a second guidewire e Results in faster procedures and fewer components Fiber length hash marks Depth markings Atraumatic distal tip in 10 cm increments to on the shaft of the fiber aid is designed to improve trackability and minimize determine treatment length in the controlled withdrawal potential tissue trauma during insertion and of the fiber during lasing placement at the saphenofemoral junction Access sheath Markings to 85 cm Access site identification markings Unique color combination identification marking indicate allows for a range indicate when the distal tip of the increases visibility in the when fiber tip is within 2 cm Of access sites fiber is approaching the access site sterile field of access sheath tip New Procedure Kit Design New package designed with SMA connector echo eic physician feedback increases access needle with clear hub usability and functionali
14. atures You Love The VenaCure 1470 nm laser has the best features of the 3 Delta laser platform including 2 un e Quality craftsmanship and high performance design 0 01 e Intuitive controls and interconnects for ease of use 0 001 e The Fiber Recognition System FRS which programs the gt 00 1000 2000 laser for the specific fiber type being used allowing for Wavelength nm fewer steps and shorter procedure time Combined with a whole new look and the innovation of the 1470 nm wavelength the VenaCure 1470 nm laser helps physicians treat more patients with ease Reliable AngioDynamics is one of the few vein treatment companies to manufacture the laser and fiber components The VenaCure 1470 nm laser is hand crafted in AngioDynamics manufacturing facility Our proven track record of reliability allows us to offer an industry leading 3 year warranty to ensure the highest quality laser and service Every laser endures a rigorous testing process throughout assembly and upon completion Ablate veins with the confidence that AngioDynamics equipment is the highest quality available on the market FEATURES SPECIFICATIONS Fiber Recognition System FRS Laser Type e Faster procedure set up with preset parameters Centre e Immediate recognition of procedure presets Wavelength e Protective door helps prevent dust particles from damaging laser or fiber Maximum Power Quality Aiming Beam e Industry leading 3 year standard war
15. cs Inc an affiliate or subsidiary May be covered under one or more of the following U S patents 6 398 777 7 483 457 7 907 643 their foreign counterparts and other patents pending 2012 AngioDynamics Inc MLC 249 US Rev E 09 12 4 VenaCureEvLT Endovenous Laser Treatment System Spotlight One Piece Sheath Procedure Kit Easier Faster and Smaller Than Other Bare Tip Fibers The Spotlight OPS procedure kit makes treating veins easier and faster than other bare tip fiber kits Designed in collaboration with leading interventional physicians the Spotlight One Piece Sheath has all the features physicians need to effectively treat the SSV the full GSV and other superficial veins of the lower extremity Easier The tungsten loaded sheath tip increases echogenicity allowing for bright and easy tip placement while the smooth soft atraumatic tip and low profile makes it easy to navigate Faster Unique self dilation technology eliminates the need for a separate dilator resulting in less components less exchanges and faster procedures Smaller A low profile sheath with a 600 um fiber angiodynamics Procedure Kit Features and Benefits Bare tip Fiber with Site Marks Site marks provide enhanced safety in positioning of laser fiber tip One Piece Introducer Sheath One piece self dilating sheath available in 25 cm 55 cm and 80 cm lengths cover a full spectrum of ablation needs Tungsten loaded Atraumatic Tip
16. d Reader Writer 10 06 0087 MMC Card 64 MB 10 06 0086 Warning Signs PP 1579 Interlock Connector AS1 A3 0024 Premium Laser Safety Glasses SE 0005 Foot Switch AS1 A0 0002 Standard Laser Safety Glasses SE 0006 Travel Case Delta Case Emergency Reset Device AS 598 Spare Key VenaCure 1470nm Laser HAR 22 0300 User Manual MAN 31 0075US Spare Fuses HAR 01 0305 AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com IMPORTANT RISK INFORMATION INDICATION FOR USE The AngioDynamics VenaCure 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 Patients should not have their varicosities ablated who have the following conditions thrombus in the vein segment to be treated an inability to ambulate severe arterial disease deep vein thrombosis or those with a history of DV
17. e New 90 cm TRE Sheath Reach new lengths with the new 90 cm NeverTouch procedure kit ideal for gaining Stainless steel braid access below the knee Improves pushability through tortuous anatomy and increases echogenicity m A Es Micro Access System AngioDynamics offers several micro access systems to satisfy a variety of clinical needs The chart below specifies the kit options and components that accompany the NeverTouch gold tip fiber 018 Micro intro 035 018 TRE Sheath New NeverTouch Needle Needle Micro access ducer sheath long access long access with dilator Fiber 018 System guidewire with dilator double ended guidewire guidewire The new 018 system System a 5F micro access sheath and eliminates the need size up resulting in fewer procedure steps and a 19 G MITO faster procedure time access System X X X NEVERTOUCH GOLD TIP FIBER PROCEDURE KITS Description Part Kit Length Long Access Guidewire Needle NeverTouch Kit 11402001 45 cm 055 21 gauge NeverTouch Kit 11402002 65 cm 035 21 gauge NeverTouch FRS Kit 11403001 45 cm 10355 21 gauge NeverTouch FRS Kit 11403002 65 cm 035 21 gauge NeverTouch FRS Kit 11403004 90 cm 0357 21 gauge NeverTouch FRS Kit 11403005 45 cm M35 19 gauge NeverTouch FRS Kit 11403006 65 cm 0957 19 gauge NeverTouch FRS Kit 11403007 90 cm 035 19 gauge NEW NeverTouch FRS Kit 11403003 25 018 21 gauge NeverTouch FRS Kit 11403012 45 cm
18. ervice e Internal sensors constantly monitor wattage ensuring a constant energy output e More than 20 safety features at and above standard Easy to Use e Intuitive user interface with fewer buttons e Programmable sound pulses allows for audible tracking of pull back rate which increases repeatability of treatment e Aiming beam with variable modes and brightness increases visibility in patient e Real time on screen display of treatment energy Lightweight Compact and Portable e Easily transported between hospital and office MultiMedia Card MMC e Stores data for at least 100 treatments e Automated tracking of procedure and fiber records e Available Patient Data Management Software and USB MMC Card Reader Writer enables easy data transfer to PC SPECIFICATIONS Laser Type Centre Wavelength Maximum Power Aiming Beam Pulse Interval Countdown Timer Power Supply Dimensions H x W x D Weight Diode laser CW class IV 810 nm Delta 15 15 W Delta 30 30 W to the respective laser output port Red Class Illa diode laser lt 5 mW at port wavelength 635 655 nm 100 ms 1000 ms 10 3200 seconds 100 240 V AC 50 60 Hz 500 VA max 150 mm x 370 mm x 325 mm x 5 mm 12 kg max Spot Handpiece Fluence Mode Fluence mode treatments provide laser energy delivered transdermally from a fixed diameter spot handpiece 2 mm or 4 mm Fixed Focus Spot Handpiece Available w
19. essories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com IMPORTANT RISK INFORMATION INDICATION FOR USE The AngioDynamics Inc VenaCure EVLT NeverTouch Direct 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 CAUTION Federal USA law restricts the sale of this device by or on the order of a physician CONTRAINDICATIONS Patients with thrombus in the vein o angiodynamics 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 mus
20. 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 USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com 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 POTENTIAL COMPLICATIONS 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 AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo and NeverTouch are trademarks and or registered trademarks of AngioDynami
21. he VenaCure EVLT logo NeverTouch NeverTouch Direct and TRE Sheath are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary AquaLiner is a trademark and or registered trademark of Nipro Corporation May be covered by or for use under one or more of the following U S patents 5 714 360 6 986 766 7 033 347 7 559 329 7 483 457 7 907 643 other U S patents and foreign counterparts pending 2013 AngioDynamics Inc MLC 470 US Rev C 02 13 4 VenaCureEvLT Endovenous Laser Treatment System NeverTouch Gold Tip Fiber THE GOLD STANDARD IN ENDOVENOUS LASER TREATMENT o angiodynamics The NeverTouch Gold Tip Fiber for Less Pain and Bruising The new NeverTouch gold tip laser fiber establishes a new standard for patient comfort visibility and ease of use The gold tip fiber eliminates laser tip contact with the vein wall which in turn minimizes perforations of the vein wall that typically result in pain and bruising as compared to traditional bare tip fibers The gold tip also maximizes ultrasonic visibility making it easier for physicians to use New laser emitting Fiber surface size 905 um Echogenic Fiber is recessed from tip Gold NeverTouch jacket The Proprietary Science Behind NeverTouch Fibers The innovation behind the NeverTouch fiber is a glass weld at the distal tip of a 600 um fiber The weld results in an effective fiber diameter of 905 um and lowers the actual po
22. 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 AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo NeverTouch Spotlight OPS and Spotlight are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary May be covered by or for use under one or more of the following patents 6 398 777 7 483 457 7 907 643 6 981 971 6 986 766 other U S patents and foreign counterparts pending 2012 AngioDynamics Inc MLC 248 US Rev E 09 12 Marketing Support um Te ER L Ju a zh ii Fy o T Lm E F PP Pa CA AngioD ynamics M VP Prg UWI Pot 4 ha lam E LIII ING venali ram nt Educatio EX LVL 4 VenaCure evit Endovenous Laser Treatment System VenaCure EVLT System Marketing Support Programs The VenaGure Sy tem You Partgetship in Practice 4 b Vent Eus MVP Program a Maximizing VenaCure EVLT Potentia M 4 o angiodynamics Get the Most in Practice Growth from AngioDynamics When it comes to practice enhancement no one offers the breadth of marketing tools and support that AngioDynamics offers and no one helps put them into action like AngioDynamics
23. ioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo NeverTouch and Maximizing VenaCure EVLT Potential are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary CAUTION Federal USA law restricts the sale of this device by or on the order of a physician 2012 AngioDynamics Inc MLC 257 US Rev E 09 12 Physician Education 4 VenaCureEvLT Endovenous Laser Treatment System VenaCure EVLT System Physician Education and Training As the first to use diode lasers in vein management AngioDynamics knows technology and clinical efficacy and understands the training and support it takes to ensure success Our Customer Care Program provides in depth customized training in all aspects of running a vein practice from technical issues to marketing techniques Customized VenaCure EVLT training includes Physician Education e On site training by experienced physician at one of our centers of excellence e Observation and insight into VenaCure EVLT system and perioperative care e Certification of successful VenaCure EVLT training e CME CEU courses available online through www VenaCure EVLT com CME Physician Reference Materials e Extensive clinical and laser reference materials e Fundamentals of phlebology tumescent anesthesia sclerotherapy and more e Online interactive procedure and adjunctive therapies training e Patient forms and ordering information Laser Installation
24. ith the Delta 30W the handpiece delivers a 2 mm or 4 mm width beam of 810 nm laser energy It incorporates a spacer to ensure that the handpiece is held at the correct distance from the treatment area and connects to the laser by a SMA 905 connector and a 1 9 m length of 600 um core fiber DELTA DIODE LASER ACCESSORIES Description Part Description Part Delta Surgical Laser 15W DELTA 15 US Patient Data Management Software ANGIODYNAMICS PDM Delta Surgical Laser 30W with DELTA 30 US CWR USB Memory Card Reader Writer 10 06 0087 Radiometer 2 MM Spot Handpiece 2mmSHP ENG MMC Card 64 MB 510 06 0086 4 Spot 4mmSHP ENG Interlock Connector AS1 A3 0024 Warning Signs PP 1496 Foot Switch AS1 A0 0002 810 and 980 nm Laser Safety Glasses SE 0004 Travel Case Delta Case Emergency Reset Device AS 598 Spare Key Delta Laser HAR 22 0300 User Manual MAN 26 0068US Spare Fuses HAR 01 0305 AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a minimally invasive choice for treating the source of their varicose veins and provides them with quicker recovery and a return to normal daily routines as compared to surgical stripping The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www
25. l 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 AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo NeverTouch TRE Sheath and Sheath Lok are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or subsidiary May be covered by or for use under one or more of the following U S patents 5 714 360 6 986 766 7 033 347 7 559 329 7 483 457 7 907 643 other U S patents and foreign counterparts pending 2012 AngioDynamics Inc MLC 201 US Rev L 09 12 4 VenaCure EVLT Endovenous Laser Treatment System 400 um Fiber Procedure 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 um Fiber Procedure Kit part of the VenaCure EVLT system e 400 um low profile fiber allows f
26. manual thoroughly prior to using the VenaCure EVLT Procedure Kits with Spotlight OPS Sheath 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 CAUTION 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 USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com 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 POTENTIAL COMPLICATIONS 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
27. ntry in a variety of educational formats to fit the needs of each physician Contact your Territory Manager for upcoming seminar dates or to enroll e Two ional course hel ne of our Centers of Excellence gt o day educational course held at one o in our physician education program Preceptorships one on one case observation with an expert in the field e Advanced educational sessions AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com o angiodynamics USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com www VenaCure EVLT com AngioDynamics the AngioDynamics logo VenaCure EVLT the VenaCure EVLT logo NeverTouch and Maximizing VenaCure EVLT Potential are trademarks and or registered trademarks of AngioDynamics Inc an affiliate or a subsidiary
28. or simple access and positioning e Less pain discomfort and potential complications compared to traditional surgery Linton Technique or subfascial endoscopic methods e Office based procedure using local anesthesia o angiodynamics Procedure Kit Features and Benefits 400 um Optical Fiber Smaller sized fiber aids in SV access and positioning 21G Venous Access Needle Ensures easy atraumatic access Actual size Small profile fits through 21G needle 400 um FIBER PROCEDURE KIT 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 Description Part 400 um Fiber Procedure Kit EVLT PVAK AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology plea
29. ranty ensures every laser will receive top notch service e Internal sensors constantly monitor wattage ensuring a constant energy output e More than 20 safety features at and above standard Pulse Interval Power Supply Easy to Use e Intuitive user interface with fewer buttons BREITER STIS e Programmable sound pulses allows for audible tracking of pull back HxWxD rate which increases repeatability of treatment e Aiming beam with variable modes and brightness increases visibility Weight in patient e Real time on screen display of treatment energy Diode laser CW class IV 1470 nm 12 W to the laser output port Red Class Illa diode laser lt 5 mW at port wavelength 635 655 nm 100 ms 1000 ms 100 240 V AC 50 60 Hz 500 VA max 150 mm x 370 mm x 325 mm x 5 mm 12 kg max The new VenaCure 1470 laser Lightweight Compact and Portable e Easily transported between hospital and office from AngioDynamics coupled with their NeverTouch fiber has given my patients the best MultiMedia Card MMC e Stores data for at least 100 treatments e Automated tracking of procedure and fiber records e Available USB MMC SD memory card card reader writer enables easy data transfer to PC outcomes with literally no post op pain and bruising W VAN GENT MD Vascular Surgeon DIODE LASER ACCESSORIES Description Part Description Part VenaCure 1470 nm Laser VCURE1470 US USB Memory Car
30. rate leads to your practice Ip Cdi ENS e Monthly email newsletters with marketing tips and ideas to help grow your practice e Reimbursement and billing guide In addition login credentials to the media website allow regular users of the VenaCure EVLT system access to all of these tools downloadable marketing materials reimbursement information and more 24 hours a day VenaCure EVLT com www VenaCure EVLT com is a website dedicated to potential patients of the VenaCure EVLT procedure and those who perform it The optimized content educates individuals suffering from superficial venous insufficiency about the disease state symptoms treatment options recovery and insurance coverage Physicians can use the site as a resource to their practice and can access AngioDynamics customer only media site portal Physician Portal CME CEU Program Links to an accredited course Product Information Explains all the features and benefits of the VenaCure EVLT system TT a ii Eedowencus Loser Vein Treabmeod Wah the Kenar pug isime LR ieri penas ag gren maru m andis ka E eran T Try am Customer Login Provides access to our customer only media Physician Locator Allows potential patients to find a local doctor who performs the 5 VenaCure EVLT procedure Before and After Images Di
31. s them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure accessories marketing materials and support and more For more information on these products including our proprietary NeverTouch fiber technology please visit www VenaCure EVLT com IMPORTANT RISK INFORMATION INDICATION FOR USE AngioDynamics Laser and VenaCure EVLT Procedure Kits with Spotlight OPS Sheath 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 CONTRAINDICATIONS 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 o angiodynamics 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
32. se visit www VenaCure EVLT com IMPORTANT RISK INFORMATION INDICATION FOR USE AngioDynamics Laser and VenaCure EVLT Procedure Kits with the 400 um 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 CONTRAINDICATIONS 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 o angiodynamics 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 um 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 CAUTION Intended for use only by
33. splays actual results of the VenaCure EVLT procedure m iam ei um aer gt mari n ciiin mars amd ma In the Media Features stories about the VenaCure EVLT procedure E Newsletter Subscription Educates potential patients about the disease state and treatment options and encourages them to find a doctor site which is our online portal for all of our advertising and practice development support Patient Education Video Informs potential patients about the procedure and its benefits Testimonials Allows potential patients to learn first hand about the procedure and how it changed other patients lives Additionally the VenaCure EVLT website e Content is written to provide in depth product information for physicians and potential referring practices e Contains links to CME CEU courses e Includes an Email newsletter registration component which continues patient education and reminds potential patients to find a doctor e Features a physician locator ml 7o 77 Venature EVET EN 4 D tor Vancose Veins gt gt Patients find a local doctor to perform the procedure leads are generated and they are sent directly to VenaCure EVLT user s doors gt gt Practice contact info and website links appear on screen and the patient receives an email with contact information for local practices that perform the VenaCure EVLT procedure PIC Ue VARICOSE VEIN TREATMENT WITH Ven Gere EVLT
34. t 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 being used CAUTION 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 USA 14 Plaza Drive Latham NY 12110 tel 800 772 6446 or 518 798 1215 fax 518 798 1360 International Haaksbergweg 75 Margriettoren 1101 BR Amsterdam Z O The Netherlands tel 31 0 20 753 2949 gt fax 31 0 20 753 2939 www angiodynamics com sign of product damage is visible Carefully read all directions and observe all Warnings and Precautions prior to performing the procedure POTENTIAL COMPLICATIONS 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 AngioDynamics the AngioDynamics logo VenaCure EVLT t
35. t from that of a standard bare tip 600 um fiber The net effect is a homogeneous ablation with less focal charring of the vein wall than that which is seen with bare tip fibers AngioDynamics patent pending technology is different from competitors with standard covered tip fibers that have the same power density as a 600 um fiber New laser emitting Fiber surface size 905 um Glass ferrule Fiber is recessed from tip Gold NeverTouch jacket NEVERTOUCH DIRECT PROCEDURE KIT Description Part Sheath Length Access Guidewire NeverTouch Direct Procedure Kit 11403101 10 cm 45 cm PROCEDURE KIT INCLUDES 1 NeverTouch Direct fiber 1 21 G echogenic access needle 1 4F 10 cm introducer dilator 1 45 cm 018 nitinol stainless steel wire ACCESSORIES Description Part Size TRE Sheath Introducer Hydrophilic Coated 11404202 45 cm TRE Sheath Introducer Hydrophilic Coated 11404203 65 cm Guidewire Double ended 3 mm J Straight eo 1101 035 x 150 Floppy tip Fixed Core PTFE Coated UP Aqua Liner Guidewire Straight Regular 60000201 035 x 150 cm AngioDynamics VenaCure EVLT endovenous laser vein treatment offers patients a proven minimally invasive choice for treating the source of their varicose veins and provides them with immediate recovery and a return to normal daily routines The VenaCure EVLT system includes 1470 nm and 810 nm lasers a choice of procedure kits procedure acc
36. ty 45 cm 018 nitinol stainless steel wire e The new fiber management system allows for controlled removal of the fiber to increase ease of use and helps maintain a sterile field sapit e Access in the sterile field from either the SMA connector or fiber tip or both e Separate micro access components packaging reduces waste e Stackable boxes with a smaller package footprint makes storage AF 10 cm introducer dialator with more efficient Fiber management system Fiber tip sidearm and hemostasis valve Procedure Steps NeverTouch Direct Kit vs NeverTouch Kits Fewer procedure steps result in a reduction of procedure time Access using Remove micro access guidewire 2 for kit and dilator arger wires E Advance treatment sheath Insert fiber place onus ctivate laser and treat vein 1 2 cm from lt u n guidewire saphenofemoral and dilator junction gt NeverTouch Direct Procedure Kit Steps gt NeverTouch Procedure Kit Steps above is an abbreviated representation of the steps to treat a vein with the VenaCure EVLT system All the steps necessary to successfully treat a varicose vein have not been included The Proprietary Science Behind NeverTouch Fibers The innovation behind the NeverTouch fiber is a glass weld at the distal tip of a 600 um fiber The weld results in an effective fiber diameter of 905 um and lowers the actual power density by 56 percen
37. wer density by 56 percent from that of a standard bare tip 600 um fiber The net effect is a homogeneous ablation with less focal charring of the vein wall than that which is seen with bare tip fibers AngioDynamics patent pending technology is different from competitors with standard covered tip fibers that have the same power density as a 600 um fiber The NeverTouch Fiber Can Successfully Treat Larger Veins BEFORE AFTER 39 2 mm GSV before Vein after Venacure laser procedure with NeverTouch fiber PROCEDURE KIT FEATURES AND BENEFITS Micro access system in convenient kangaroo pouch NeverTouch FRS fiber Select from a variety of micro access Fiber recognition system is compatible with all kits all packaged on the outside in a AngioDynamics lasers separate sterile pouch Sliding sheath gauge Aids in marking treatment length and holding sheath in place during tumescent T Sheath Lok system anesthesia Enables precise placement at the saphenofemoral junction by locking the pe gt Available witha 946219 fiber to the sheath assuring the fiber gauge needle stays a safe distance outside the sheath New 19 gauge needle now available for physicians who prefer to insert 4F TRE Sheath hydrophilic coated introducer the 035 wire directly translucent radiopaque echogenic p through the needle Echogenic for easy positioning and hydrophilic coating to reduce procedure tim
38. world s largest endovenous laser ablation company Easy Between the Fiber Recognition System which facilitates fewer steps enabling a shorter procedure set up and the MultiMedia Card which helps manage patient data between the laser and patient files the Delta laser helps physicians treat more patients with ease Every component of the Delta laser is designed for high performance Controls and interconnections are kept to a minimum and carefully placed making the interface simple and easy to use In addition the Delta 810 nm laser is available in 15 or 30 watts Reliable AngioDynamics is one of the few vein treatment companies to manufacture the laser and fiber components The Delta 810 nm laser is hand crafted in AngioDynamics manufacturing facility Every laser endures a rigorous testing process throughout assembly and upon completion allowing clinicians to ablate veins with confidence Proven The Delta 810 nm has more than 10 years of clinical evidence It was the first laser for endovenous ablation to receive FDA clearance and it continues to effectively treat varicose veins associated with venous disease FEATURES Fiber Recognition System FRS e Faster procedure set up with preset parameters e Immediate recognition of procedure presets e Protective door helps prevent dust particles from damaging laser or fiber Quality e Industry leading 3 year standard warranty ensures every laser will receive top notch s
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