StarBurst RFA Promotional Literature
Contents
1. SDE SPECIFICATIONS The Cannula tip should be 1 5 cm from the center of the ablation Three arrays plus active trocar tip Three thermocouples The Ultimate in Linear Deployment RADIOFREQUENCY ABLATION UniBlate RFA Device The UniBlate RFA electrode provides linear scalable ablations from 1 to 3 cm in length and 1 to 2 5 cm in diameter The benefits of ablation scalability with the same electrode are lower product stocking costs and the ability to spare the most normal tissue possible The UniBlate electrode provides a very low profile for CT gantry compatibility A built in thermocouple provides full temperature feedback and RF power control as well as a cool down cycle and track ablation capabilities c gt e 2 25 mm 1em posure 1 5 cm ablation length 4 0 25 MM 2 cm exposure gt p5 25 m ablation length 0 25 mm 25 cm exposure cm ablation length FEATURES amp BENEFITS SPECIFICATIONS UniBlate exclusive linear deployment electrode feature allows user to dial in the desired length of active electrode One thermocouple The most CT gantry compatible electrode available with right angle cable connection Built in cool down process after each ablation Provides full track ablation capabilities Eliminates the need to stock multiple electrodes for multiple ablation volumes Fully compatible with the AngioDynamics 1500X RF Generator Added2. is bone metastases do not perform RF ablation weight bearing bone with evidence of impending fracture Pathologic fracture is more prevalent and serious in long bone The Talon is not MRI safe Please see package insert for complete list of warnings and precautions POTENTIAL COMPLICATIONS Published reports on the use of the RFA system indicate low overall complication rates These include bleeding abscesses and in cases involving the treatment of bone tumors fractures and nerve damage Indications contraindications warnings and instructions for use can be found inthe instructions for use supplied with each device Observe all instructions prior to use Failure to do so may result in patient complications CAUTION Federal USA law restricts the sale of the device by or on the order of a physica Consult your AngioDynamics representative for country specific product availability o angiodynamics USA gt 14 Plaza Drive Latham NY 12110 gt tel 800 772 6446 gt fax 518 798 1360 gt Canada tel 800 268 0184 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 wwwangiodynamics com AngioDynamia the AngloDynamics logo Starts the StarBurst logo UniBlate and RITA are trademarks and or registered trademarks of AngloDynamics Inc an affilate or a subsidiary Habib isa registered trademark of Emdsion Ltd
3. 2015 AngioDynamics Inc MLC 613 Rev A DIIS
4. lesion size may result Do not use the IntelliFlow Pump if damage is suspected Electric shock hazard do not saturate the IntelliFlow Pump with liquids or allow liquids to run inside the unit or immerse the Intellitlow Pump in water do not use the RF Generator if it has been dropped or damaged and do not remove the cover of the RF Generator There are no user serviceable parts inside the RF Generator Refer all service to AngioDynamics Inc Use of the 1500X Generator may interfere with the operation of other electronic medical equipment In the case of a pacemaker a theoretical hazard exists because interference with the action of the pacemaker may occur and the pacemaker may reset to its factory default it is recommended that a patient see a cardiologist after the procedure to verify functionality of the pacemaker It is important to read understand and follow the instructions warnings and precautions supplied with the equipment in order to enhance procedure safety and effectiveness POTENTIAL COMPLICATIONS Possible complications include bleeding infection wound dehiscence gas embolism nerve damage electric shock or thermal injury 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 CAUTION Federal USA law restricts the sale of the device b
5. 31 Main Cable Green 9 to 14 pin 700 101892 MODEL 1500X RF GENERATOR REPLACEMENT PARTS Product Name UPN Foot Switch 400 100453 Power Cord 400 100702 INTELLIFLOW PUMP Product Name UPN IntelliFlow Pump 700 102941 INTELLIFLOW PUMP REPLACEMENT PARTS Product Name UPN Pump Communication Cable 700 102801 Power Cord 400 100702 Occlusion Bed 700 102938 IMPORTANT RISK INFORMATION INDICATIONS FOR USE The IntelliFlow Infusion Pump Tubing Set and Reusable Occlusion Bed is designed for use in conjunction with the 1500X Radiofrequency RF Generator to provide local delivery of saline through the irrigation ports of the electrosurgical device during radiofrequency ablation procedures The 1500X Generator with software version 8 10 or higher provides monopolar RF energy and is indicated for use in percutaneous laparoscopic or intraoperative coagulation and ablation of soft tissue CAUTION Federal USA law restricts the sale of these devices by or on the order of a physician CONTRAINDICATIONS Do not use the Intelliflow Pump for drug delivery for intravascular intra arterial or epidural delivery of fluids or during MRI procedures The use of the 1500X Generator is contraindicate the presence of flammable anesthetics oxygen enriched or explosive atmospheres WARNINGS AND PRECAUTIONS Do not use the IntelliFlow Pump if four or more tubes become occluded as improper or unpredictable
6. 930 14 gauge 6 4 French StarBurst XL Electrode 15cm 700 101320 14 gauge 6 4 French StarBurst XL Electrode 25cm 700 101317 14 gauge 6 4 French StarBurst XL Electrode w attached cable 10cm 700 103903 14 gauge 6 4 French StarBurst XL Electrode w attached cable 15cm 700 103902 14 gauge 6 4 French StarBurst XL Electrode w attached cable 25cm 700 103901 14 gauge 6 4 French Main Cable Green 9 to 14 pin n a 700 101892 STARBURST XL SEMI FLEX ELECTRODES Product Name Length UPN Outer Diameter O D StarBurst XL Semi Flex Electrode 25cm 700 102615 14 gauge 6 4 French StarBurst XL Semi Flex Electrode w attached cable 25cm 700 103909 14 gauge 6 4 French COAXIAL ACCESS SYSTEM INTRODUCERS Introducer Type Length UPN XL 10 cm XL 15 cm XL 25 cm XL Semi Flex 25 cm Hard Introducer 6cm 700 102330 to hub to 10 cm mark tol cmmark to 10 mark Hard Introducer 11cm 700 102331 not compatible to hub to15cm to 15 cm mark STARBURST SDE ELECTRODES Product Name Length UPN Outer Diameter O D StarBurst SDE Electrode 12cm 700 102486 17 gauge 4 5 French StarBurst SDE Electrode w attached cable 12cm 700 103908 17 gauge 4 5 French UNIBLATE ELECTRODES Product Name Length UPN Outer Diameter o d UniBlate 10cm 700 103598 17 gauge 5 French UniBlate 15cm 700 103597 17 gauge 5 French UniBlate 25cm 700 103530 17 gauge 5 French MODEL 1500X GENERATOR AND ACCESSORIES Product Name UPN 1500X RF Generator 700 1017
7. Optimization for Multtined Radiofrequency Ablation Comparative Study in ex vivo and in vivo bovine Iver L Appelbaum 1 Sosa R Pearson S Perez L Nisenbaurm P Mertyna E and SN Goldberg The Ultimate in Array Design RADIOFREQUENCY ABLATION StarBurst XL RFA Device Its real time multi point temperature feedback system ensures sustained target temperatures during the procedure The patented temperature based end point provides predictable volumes of ablation with low local recurrence rates Needle track ablation adjustable array size and temperature based technology of the revolutionary first generation StarBurst XL RFA electrode assures a high level of confidence that coagulative necrosis is taking place throughout the targeted radiofrequency interstitial tissue ablation Slim handle design Nine arrays plus active trocar tip StarBurst XL Semi Flex RFA Device The StarBurst Semi Flex RFA electrode is a versatile device that features both rigid metal and flexible polymer trocar sections Its ability to bend up to 90 degrees in all directions enables easy gantry entrance for MRI and CT systems This teaming of innovative needle design with imaging systems compatibility allows the StarBurst Semi Flex RFA electrode to be used in percutaneous procedures With multiple spherical ablation size capabilities of up to 5 cm in diameter at 1 cm increments the Semi Flex covers P4 a broad spectrum of applica
8. UStarBurst Radiofrequency Ablation Electrodes o angiodynamics Fast 4 cm ablation in an average of 11 minutes StarBurst Talon RFA Device Ergonomic one hand design Four active arrays plus active trocar tip provides superb clinician controls fast spherical ablations Thermocouple in tip of each active array StarBurst Talon Semi Flex RFA Device Bending capacity up to 90 degrees P a Rigid section fits easily through the CT gantry of trocar is 13 cm 7 Flexible section of trocar is 12 cm Scalable Spherical Ablations 1 4 cm Diagram is not drawn to scale No Arrays Deployed 0 25 cm Margin 2 Ablation 0 minutes 0 5 Margin Ablation 3 cm Ablation 5 minutes 0 75 cm Margin 1em Tumor 3 5 cm x 3 cm Ablation 1 Hold Time at Target Temperature Set Timer 4 Ablation 9 minutes 1 Margin 2 cm Tumor BENEFITS Side deployment allows easier penetration of mobile tumors Easy to position for both surface and difficult to reach dome lesions Integrated disposable main cable and tubing allows for easy set up Solid tip allows easier penetration of hard tumors Multi point temperature feedback provides controlled ablation Needle track ablation Used for percutaneous laparoscopic and open cases Saline infusion during RFA is associated with lower impedance higher power d
9. elivery and larger lesion size CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY 2004 27 4 361 5 ISSN 0174 1551 Gananadha 5 Morris DL UNSW Department of Surgery St George Hospital Sydney Australia The Ultimate Micro Infusion System RADIOFREQUENCY ABLATION StarBurst Xli enhanced RFA Device The StarBurst Xli enhanced RFA electrode offers clinicians the first single placement RFA device designed to create soft tissue ablation sizes of 4 7 cm It can be used for percutaneous laparoscopic and intraoperative procedures This minimally invasive RFA device ensures consistent sustained target temperatures and enables the precise ablation of predictable volumes of tissue The StarBurst Xli enhanced RFA electrode reduces the time required to perform procedures and in many cases enables patients to resume normal activity within days Ergonomic one hand design Nine arrays plus active trocar tip provides superb clinician controls facilitates more robust ablations 7 cm ablation with single device placement StarBurst Xli enhanced Semi Flex RFA Device The StarBurst Xli enhanced Semi Flex RFA electrode is designed specifically for Interventional Radiologists It is a versatile RFA device that features both rigid metal and flexible polymer trocar sections The StarBurst Xli enhanced Semi Flex offers all the benefits of the Xli enhanced rigid device but with the ability to bend up to 90 degrees in all directions L which enables eas
10. ial risk of patient or user infections Contamination of the device may lead to injury illness or death of the patient Reprocessing may compromi the integrity of the device and or lead to device failure PRECAUTIONS Do not bend or kink the trocar This may cause damage and result in a nonfunctional device If the device is being used in a laparoscopic procedure care must be taken to avoid a gas embolism If the device is being used in a laparoscopic procedure activation of the device when not in contact with target tissue may cause capacitive coupling Having RF power on at the same time as infusion using a method different from these instructions may alter the path of the electrical energy away from target tissues Refer to individual product IFUs and or User Manual to see full Warnings Precautions Possible Adverse Effects and Contraindications Observe all instructions prior to use Fai so may result in patient complications reto CAUTION Federal USA law restricts the sale of the device by or on the order of a physician The StarBurst Talon StarBurst Xli enhanced StarBurst XL StarBurst MRI and StarBurst SDE Electrosurgical Devices are tools to transmit monopolar radiofrequency energy provided by the 1500X RF Generator in conjunction with the IntelliFlow Infusion pump They areindicated for use in percutaneous laparosco itraoperative coagulation and ablation of soft tissue including the partial
11. ng Temperature 15 C 35 C e Speed Flow Rate 1 40 rpm 05 7ml min STARBURST TALON ELECTRODES Product Name Length UPN Outer Diameter O D StarBurst Talon Electrode 15cm 700 102847 14 gauge 6 4 French StarBurst Talon Electrode 25cm 700 102846 14 gauge 6 4 French STARBURST TALON SEMI FLEX ELECTRODE Product Name Length UPN Outer Diameter O D StarBurst Talon Semi Flex Electrode 25cm 700 102845 COAXIAL ACCESS SYSTEM INTRODUCERS 14 gauge 6 4 French rigid portion Introducer Type Length UPN Talon 15 cm Talon 25cm Hard Introducer 6cm 700 102330 to 12cm mark to 12 cm mark Hard Introducer 11cm 700 102331 not compatible to 17 cm mark STARBURST XLI ENHANCED ELECTRODES Product Name Length UPN Outer Diameter O D StarBurst Xli enhanced Electrode 12cm 700 103027 14 gauge 6 4 French StarBurst Xli enhanced Electrode 25cm 700 103024 14 gauge 6 4 French STARBURST XLI ENHANCED SEMI FLEX ELECTRODE Product Name Length UPN Outer Diameter O D StarBurst Xli enhanced Semi Flex Electrode 25 cm 700 104077 14 gauge 6 4 French rigid portion COAXIAL ACCESS SYSTEM INTRODUCERS Introducer Type Length UPN Xlie 12 cm Xlie 25cm Hard Introducer 6cm 700 102330 to 10 cm mark to 10 cm mark Hard Introducer 11cm 700 102331 not compatible to 15 cm mark STARBURST XL ELECTRODES Product Name Length UPN Outer Diameter O D StarBurst XL Electrode 10cm 700 101
12. o additional capital expense SPECIFICATIONS Dimensions 14 75 w x 17 0 d x 5 25 h 37 5 cm x 43 cm x 13 5 cm Weight 23 Ibs 10 kg Power 1 250 Watts Frequency 460 kHz Power Delivery Accuracy 2096 Power Supply 110 240 volts 50 60 Hz universal power supply Temperature Control Range 15 125 C 3 C up to 8 independent channels Efficiency Range 1 10 IntelliFlow Pump The IntelliFlow peristaltic infusion pump is used in conjunction with the 1500X radiofrequency generator for the coagulation and ablation of soft tissue The IntelliFlow offers the ultimate in ease of use while delivering infused saline with automated precision The IntelliFlow pump is specifically designed to be used with all infusion based StarBurst electrosurgical devices ANGICDYNAMICS RITA IrtelliFlow Pump Occlusion Bed Compatible with all StarBurst infusion based devices AL BENEFITS Automated communication with 1500X generator Integrated IV pole No battery to recharge No additional settings required Easy loading amp securing of tubing sets Storage drawer for accessories Tubing sets are sterile and pre attached to StarBurst family of infusion devices Occlusion bed offers easy device set up SPECIFICATIONS Dimensions 14 75 w x 8 8 d x 6 25 h 37 46 cm x 22 35 cm x 15 90 cm Weight 10 Ibs 4 5 kg Power 100 240 VAC Frequency 50 or 60 Hz e Operati
13. opk radiofrequency ablation of hepatic tumors Prospective clinical evaluation of ablation size comparing two treatment algorithms E Berber N L Herceg Casto A E Sbentein Surgical Endoscopy 2004 18 390 396 2 SurgEndosc E Berber NL Herceg KI Casto amp AE Siperstein 2004 18 390 396 The Ultimate in Array Design RADIOFREQUENCY ABLATION StarBurst SDE RFA Device The StarBurst SDE RFA electrode features a first in the industry unique side deployed arrays that allow physicians to precisely position the trocar tip and see its location with greater ease It is designed for small lesions where a finer gauge may be of benefit With the StarBurst SDE RFA electrode stage deployment is not required Instead physicians deploy the device to the desired size and maintain the prescribed temperature and duration to complete the ablation Like all StarBurst RFA devices the SDE features controlled temperature monitoring through multi point temperature feedback Slim handle design Three arrays plus active trocar tip SDE Scalable Spherical Ablations 2 cm SDE BENEFITS Diagram drawn to scale e Straight needle with side deployed arrays Small needle gauge and sharper trocar tip Size cm Volume cm for easier access into the lesion site 20 142 Smaller spherical ablations 2 cm Dynamic real time temperature readouts N Multi point temperature feedback Patented side deployment array design
14. or complete ablation of non resectable liver lesions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy CAUTION Federal USA law restricts the sale of this device by or on the order of a physician CONTRAINDICATIONS None known WARNINGS AND PRECAUTIONS For single use only Do not bend or kink the trocar or the needles or exert forceful pressure on Device while it is deployed in the tissue do not attach anything e clamps etc to the Device or use metal introducers that do not have ulation inadvertent patient injury may result To ensure safe and effective use follow the manufacturers directions and recommended practices for the preparation placement surveillance removal and use of the dispersive electrode To achieve the desired ablation follow the manufacturer s guidelines of ablation time and temperature Ensure that the dei placed at least 1 away from structures not intended for ablation In laparoscopic procedures care must be taken to avoid a gas embolism and activation of the device when not in contact with target tissue may cause capacitive coupling In some cases a liver lesion will only be partially destroyed the final determination of the success of lesion destruction can only be made by aging studies following the procedure and during regular long term follow up For ablation of painful
15. safety near critical structures 3 In Vivo Porcine Ablation Data per UniBlate IFU Single 17 gauge cannula electrode with scalable active length from 1 2 5 cm The Ultimate in Power and Ease of Use CAPITAL EQUIPMENT Model 1500X RF Generator The 1500X Electrosurgical Radiofrequency Generator supplies radiofrequency RF energy for the partial or complete coagulation and ablation of soft tissue The 1500X is specifically designed to be compatible with the full family of AngioDynamics RFA based electrodes The innovative electrosurgical devices can be utilized in percutaneous open or laparoscopic surgical procedures Compatible with the StarBurst and Habib families of devices A E BENEFITS Generator is equipped with computer driven protocols that automatically adjust wattage to maintain optimal temperatures during the ablation Temperature monitoring is in real time which gives immediate visibility of the ablation zone and repeatable reliable procedure endpoints 250 Watts of power combined with the IntelliFlow saline infusion pump allows faster and larger ablations Immediately recognizes the full family of AngioDynamics electrosurgical devices as they are plugged in and automatically sets the system to pre loaded soft tissue protocols Remote foot pedal available for hands free device activation Smart Card Technology means that upgrades can be accomplished with little or n
16. tions Rigid section of trocar is 12 cm Flexible section of trocar is 13 cm Bending capacity up to 90 degrees fits easily through the CT gantry Because Temperature Matters This minimally invasive RFA device ensures consistent sustained target temperatures and enables the precise ablation of predictable volumes of tissue gt Pre Ablation gt Post Ablation Scalable Spherical Ablations 3 5 cm Diagram drawn to scale Size Volume cm 50 1655 aon 335 The Cannula tip should be 1 5 cm from the center of the ablation The Cannula tip should be 1 0 cm from the center of the ablation BENEFITS A single device with the capability to produce scalable spherical ablations 3 5 cm Patented expandable multi array space filling configuration Predictable repeatable ablations Multi point temperature feedback with dynamic real time readouts 5 mm active tip allows for needle track ablation Slim handle design Small minimally invasive incision with no soft tissue introducer required Fits both CT and MRI gantries Beveled surgical tip for easier penetration of hard tumors SPECIFICATIONS Nine arrays plus active trocar tip Five thermocouples 531 ablated lesions in 154 patients confirmed the optimal algorithms for creating dependable reproducible zones of ablation up to 5 cm with the StarBurst XL RFA device Laparosc
17. y entrance through the CT gantry Flexible section of trocar is 13 cm o id section zd of trocar is 12 Bending capacity up to 90 degrees fits easily through the CT gantry Because Temperature Matters This minimally invasive RFA device ensures consistent sustained target temperatures and enables the precise ablation of predictable volumes of tissue gt Pre Ablation gt During Ablation gt Post Ablation Scalable Spherical Ablations 4 7 cm Diagram drawn to scale Size cm Volume cm 70 1796 6o 134 50 65 5 40 i335 The Cannula tip should be 1 5 cm from the center of the ablation The Cannula tip should be 2 0 cm from the center of the ablation BENEFITS More robust ablations Faster ablation times e Scalable spherical ablations 4 7 cm Dynamic real time temperature readouts Needle track ablation Superb ergonomics and clinician controls Expandable array configuration e Infusion based system increases conductivity of ablation zone Ergonomic one hand design Integrated tubing set allows for easy set up SPECIFICATIONS Nine arrays plus active trocar tip Four thermocouples Pre attached disposable main cable With proper electrode placement and technique a single 15 Ga multi tined electrode insertion can be used to cover and destroy 5 cm tumors with appropriate ablative margins NAHUM GOLDBERG MD Algorithm
18. y or on the order of a physica INDICATIONS FOR USE The Uniblate Electrosurgical Device is intended for coagulation and ablation of tissue during percutaneous laparoscopic and intraoperative surgical procedures such as partial or complete ablation of non resectable liver lesions osteoid osteoma and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy DESCRIPTION The UniBlate device consists of an insulated primary trocar with two infusion holes and a temperature sensor positioned at the distal end The UniBlate device is designed to fit in a CT gantry is available in 10cm 15cm amp 25cm lengths and has a integrated main cable and tubing set To be used in conjunction with the RITA 1500X RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue WARNINGS The distal 4 mm of the device is NOT Radio opaque and will not appear under CT imaging If the Tubing Set becomes occluded improper or unpredictable lesion size result Do not attach anything i e clamps etc to the device This may damage the insulation which could contribute to patient injury Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive electrodes Patients with skin are at increased risk of skin damage from the adhesive on the Dispersive pads Reuse of single use devices creates potent
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