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CRM Product Guide

1. Catheter shape gains support from the superior vena cava SVC to provide access to the CS and branch vein for guide wire and direct lead delivery Product Description RAPIDO ADVANCE 0D 8F Coronary Sinus Extended ID 6 6F 0 087 2 21 mm Hook Straight Right Compatible with IS 1 and LV 1 CS EH ST R EASYTRAK family of leads guide catheter 7717 Working length 47 cm Overall length 53 cm 1718 Working length 52 cm Overall length 58 cm 7719 Working length 57 cm Overall length 63 cm Intended use and features Catheter shape gains support from the SVC to provide access to the CS and branch vein for guide wire and direct lead delivery units per package Diagram Product RAPIDO Cut Away Coronary Sinus Extended Hook CS EH guide catheter 7511 Working length 42 cm Overall length 48 cm 7553 Working length 47 cm Overall length 53 cm RAPIDO Cut Away Coronary Sinus Hook CS H guide catheter 7556 Working length 42 cm Overall length 48 cm 7557 Working length 47 cm Overall length 53 cm RAPIDO Cut Away Coronary Sinus Extended Hook Right CS EH R guide catheter 7519 Working length 42 cm Overall length 48 cm 7563 Working length 47 cm Overall length 53 cm Description 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYT
2. Defibrillation Lead Accessories Product Model Length cm Diagram DF 1 Port Plug 1 6996 2 DF 1 terminals N A TVI Tool Kit 7600 1 9F TVI tool Hemostatic introducer For use with white handle RELIANCE G leads 1 11F TVI tool green handle Lead Cap Kit 2 DF 1 2 IS 1 2 4 75 mm connectors Lead Cap Kit 6810 2 6 1 mm connectors Lead Adapter bi 2 6 1 mm connectors 1 DF 1 terminal 2 DF 1 connectors 1 DF 1 terminal Lead Adapter Product Model From Lead Adapter 6836 2 6 1 mm connectors Lead Adapter 6931 1 6 1 mm connector Lead Adapter 6952 2 DF 1 and 1 1S 1 connectors 1 6 1 mm terminal 1 DF 1 terminal 2 DF 1 and 1 IS 1 terminals Length cm Diagram Defibrillation Stylets Model Length cm Type Firmness ee Knob Color Cap Color in Straight Sot um Straight Firm 006 Straight Firm 006 Straight Sot oou Straight Firm 006 HTM MOM HTM EA un Yellow Orange Green White Black Green Black Green Straight 10 Straight 10 Straight Straight Straight 6964 6971 31 Defibrillation Lead Stylets Product Description Length cm Terminal Polarity Diagram ACUITY Steerable Coronary venous pace 80 IS 1 Bipolar sense lead 90 Either over the wire or stvlet deliverv IROX electrode coating 1S 1 Steroid elution Pre shaped J fixation ACUITY Spiral Coronary venous pace Unipolar
3. Balloon catheter 6714 90 cm 6747 110 cm Safesheath introducer 6709 9F 6713 11F Description e6F e 90 cm units per Intended use and features package e Aids in obtaining venograms by occluding the CS e Manufactured by Arrow International e Hemostatic e Tear away e Introduces various tvpes of pacing leads and catheters into the venous svstem e Manufactured by Pressure Products Medical Supplies Inc Frequently Used Accessories Diagram Product Three way stopcock 6798 Suture sleeve 6773 Torque device 6740 Description e Manufactured by DeRoyal Industries e Adjustable tubular reinforcement positioned over outer lead insulation e Silicone e Torque device Frequently Used Accessories units per Intended use and features package e Provides control to the open port on an RHV eSecures and protects EASYTRAK family of leads at venous entry site after lead placement e Tracks over the proximal end of the guide wire and locks into position e Steers guide wire into position Diagram Product Lead adapter 6744 Lead adapter 4402 Lead adapter 4403 Description e Lead adapter e Unipolar e BLV BIS 17 e17 cm unipolar bipolar e Manufactured by Oscor Inc e BLV BIS 17 e17 cm unipolar bipolar eManufactured by Oscor Inc Intended use and features Joins an IS 1 lead to an LV 1 lead port e Joins an IS 1 lead to an LV 1 lead port e Join
4. Compatible with EASYTRAK LV 1 EASYTRAK 2 LV 1 and EASYTRAK 3 LV Compatible with EASVTRAK IS 1 EASYTRAK 2 1S 1 EASVTRAK 31S 1 ACUITV Steerable and ACUITV Spiral Intended use and features Smaller tip diameter profile designed for easier tracking through tortuous anatomy Smaller tip diameter profile designed for easier tracking through tortuous anatomy Finishing Wires units per package Diagram 45 Product LV 1 hemostasis valve 6789 packaged with 2 wire guides LV 1 lead port plug 6743 LV 1 lead cap 6742 Rotating hemostatic valve 6745 Description e Bleedback control valve flushing portfor LV 1 leads e LV 1 lead port plug e LV 1 lead cap e Bleedback control valve e D 0 096 units per Intended use and features package Diagram e Controls bleedback e Facilitates lead flushing during implant e Seals unused LV 1 port e Protects EASY TRAK lead LV 1 connector pin e Controls bleedback e Attaches to proximal end of guide catheter LV 1 Accessories Product Description IS 1 hemostasis valve e Bleedback control valve 6799 packaged with 2 wire guides with flushing port for IS 1 leads IS 1 lead port plug e S 1 lead port plug 6998 Lead cap kit e 2 DF 1 lead caps 6623 e 2 IS 1 lead caps e 2 4 75 mm lead caps IS 1 Accessories Intended use and features e Controls bleedback e Facilitates lead flushing during implant
5. High Impedance Dual coil DF 1 IS 1 Steroid elution Integrated bipolar ePTFE covered coil High Impedance Single coil DF 1 IS 1 Steroid elution Integrated bipolar Defibrillation Leads Insulation Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Diagram Product ENDOTAK RELIANCE Active Fixation ENDOTAK RELIANCE S Active Fixation ENDOTAK RELIANCE Passive Fixation ENDOTAK RELIANCE S Passive Fixation Description Terminal pin driven Extendable retractable 8 turns 0157 0158 10 turns 0159 Dual coil DF 1 IS 1 Steroid elution Integrated bipolar Terminal pin driven Extendable retractable 8 turns Single coil DF 1 IS 1 Steroid elution Integrated bipolar High Impedance Dual coil DF 1 IS 1 Steroid elution Integrated bipolar High Impedance Single coil DF 1 IS 1 Steroid elution Integrated bipolar Defibrillation Leads Model 0157 0158 0159 0137 0138 0147 0148 0149 0127 0128 Length cm Insulation Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Silicone Diagram Length Product Description cm Insulation ENDOTAK SQ Subcutaneous lead array 10 Silicone Array XP DF 1 with built in DF 1 port 3 common coils Used with ENDOTAK leads Diagram
6. e Seals unused IS 1 port e Protects DF 1 IS 1 and 4 75 mm connector pins units per package Diagram 2 of each size 6 total IS 1 Accessories Product ACUITY Universal Cutter 7060 RAPIDO Cut Away rotating hemostatic valve 7565 RAPIDO Cut Away bleedback control valve 7568 IS 1 lead delivery system accessory kit 7611 Description e Cutter compatible with all Boston Scientific left ventricular leads e Bleedback control valve e D 0 185 e Compatible with both RAPIDO ADVANCE and RAPIDO Cut Away e Spring type e Bleedback control valve e D 0 187 Compatible with both RAPIDO ADVANCE and RAPIDO Cut Awav e Torque device 6740 e 2 Three wav stopcock 6798 e Rotating hemostasis valve 6745 e RAPDIO Cut Awav cutter 7566 e RAPDIO Cut Awav rotating hemostatic valve 7565 e RAPDIO Cut Awav bleedback control valve 7568 e Guide wire introducer units per Intended use and features package Diagram e Universal lead management system accepts lead bodies up to 6F e Enlarged proximal space accommodates a pre loaded suture sleeve e Metal lead shield designed to protect lead during cutting e Controls bleedback e Attaches to proximal end of guide catheter e Controls bleedback minimizes blood loss without restricting device movement e Attaches to proximal end of guide catheter e Conveniently provides commonly used accessories in one kit Product
7. CONTAK RENEWAL 3 HE 1853 VENTAK PRIZM DR HE T167 VITALITY 2 EL DR H179 CONTAK RENEWAL 3 HE 1858 VENTAK PRIZM DR HE T175 VITALITY 2 VR 1861 VENTAK PRIZM 2 DR 1177 VITALITY 2 EL VR LATITUDE Push Button Wireless Communicator Model 6482 fie r 4 CRT D Wireless CRT D Wireless ICD Wireless hs H210 CONTAK RENEWAL 3 RF H220 LIVIAN RF E030 CONFIENT RF HE H215 CONTAK RENEWAL 3 RF H225 LIVIAN RF H217 CONTAK RENEWAL 3 RF HE H227 LIVIAN RF HE H219 CONTAK RENEWAL 3 RF HE H229 LIVIAN RF HE LATITUDE Touch Screen Wireless Communicator Model 6476 CRT D Wireless N118 N119 COGNIS RF HE COGNIS RF HE ICD Wireless E102 E110 TELIGEN VR RF HE TELIGEN DR RF HE Longevity Volume Thickness Product Description Model Type years cc mm Header Diagram ALTRUA 60 AV Delay extendable to 400 ms IS 1 MV Blended Sensor 3 2 mm IS 1 compatible Stored Onset EGMs IS 1 Automatic Capture i IS 1 AV Search Hysteresis AutoLifestyle Ventricular Rate Regulation Sudden Brady Response ALTRUA 40 MV Blended Sensor Stored Onset EGMs AV Search Hysteresis Ventricular Rate Regulation Sudden Brady Response ALTRUA 20 Stored Onset EGMs l 3 2 mm IS 1 compatible Accelerometer Sensor IS 1 Dynamic AV Delay 5 6 mm Sudden Brady Response on 1 Longevity projections as described in device user manual Settings 60 ppm A 2 5 V V 1 0 V 500 ohms 100 paced MV Blended Sensor ON Onset EGMs ON Automatic Capture ON 2
8. Leads from Boston Scientific CRM Indications Pacemaker indications include symptomatic paroxysmal or permanent second or third degree AV block symptomatic bilateral bundle branch block symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders bradycardia tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias neurovascular vaso vagal syndromes or hypersensitive carotid sinus syndromes Adaptive rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and or level of physical activity Pacemakers dual chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony Dual chamber modes are specifically indicated for conduction disorders that require restoration of AV synchrony including varying degrees of AV block VVI intolerance eg pacemaker syndrome in the presence of persistent sinus rhythm Pacing leads from BSC CRM are intended for chronic pacing and sensing of the atrium and or ventricle when used with a compatible pulse generator Contraindications Pacemakers are contraindicated for the following patients under the circumstances listed patients with unipolar pacing leads or in MV mode with an implanted ICD because it may cause unwanted delivery or inhibition of ICD therapy use of the MV sensor in patients with only un
9. The Guidant Rotating Hemostasis Valve is intended for maintaining a fluid tight seal around devices including implantable coronary venous leads during the implant procedure The Guidant Bleedback Control Valve is intended for maintaining a seal around diagnostic interventional devices with an outside diameter of less than 0 185 in the venous anatomy only during interventional procedures The Guidant Cutter is intended to facilitate RAPIDO Cut Away or RAPIDO ADVANCE guiding catheter removal after the Guidant coronary venous lead is positioned Intended Use The Guidant RAPIDO Cut Away and RAPIDO ADVANCE guiding catheters are intended to be used with the Guidant Rotating Hemostasis Valve a Guidant Cutter and a commercially available luer lock stopcock Contraindications The Guidant Bleedback Control Valve is not intended for use with pressure injections of greater than 30 psi Warnings These devices are distributed STERILE NON PYROGENIC and are intended for one time use only DO NOT resterilize and or reuse them as this can potentially result in compromised device performance and risk of inappropriate sterilization and cross contamination Sideholes should not be placed in the shaft of the guiding catheter by the user Puncturing the shaft of the guiding catheter with hospital instruments may lead to thrombogenesis or failure of shaft integrity When this guiding catheter is in the body it should be manipulated while under high quality fluo
10. Type cm Firmness in Model Knob Color Cap Color Tapered 45 Soft 0 013 6044 Tapered 45 Limber 0 014 6032 zz Tapered 45 Firm 0 016 White 0 013 0 013 6032 6035 Tapered 52 Soft 0 013 6045 Mint 6033 6036 013 6046 0 013 Limber straight Straight Straight Tapered Limber 0014 Green Mint Tapered 52 Firm 0 016 Mint Tapered 58 Soft 0 013 6046 Tapered 58 Limber 0 014 6034 een Tapered 58 Firm 0 016 6037 White EN EN Limber Greer Firm 24 Limber Straight Straight Straight Straight Straight Atrial 45 Soft 0 013 6050_ Atrial 45 Limber 0 014 6038 zz Atrial 45 Firm 0 016 6041 White Atrial 52 Soft 0013 6051_ Atrial 52 Limber 0014 6039 MOKON Mint Atrial J 52 Firm 0 016 6042 White Mint Firm 58 ER 58 EN so EN Straight 58 REM EM Product ENDOTAK RELIANCE G Active Fixation ENDOTAK RELIANCE SG Active Fixation ENDOTAK RELIANCE G Passive Fixation ENDOTAK RELIANCE SG Passive Fixation Length Description Model cm ePTFE covered coils Terminal pin driven Extendable retractable 8 Turns 10 turns 0187 Dual coil DF 1 IS 1 Steroid elution Integrated bipolar ePTFE covered coil Terminal Pin driven Extendable retractable 8 turns Single coil DF 1 IS 1 Steroid elution Integrated bipolar ePTFE covered coils
11. and Diagnostic Procedures As an implanted pacing lead is a direct low resistance path to the myocardium for electrical current the observance of high standards of electrical safety is required Electrosurgical instruments for example could generate voltages of such amplitude that a direct coupling between the tip of the electrocautery device and the implanted lead may result possibly inducing myocardial lesions or serious cardiac arrhythmias e g fibrillation Some therapeutic and diagnostic procedures e g diathermy MRI electrocautery may result in latent damage to the pacing system This damage may not be detected when testing the pacemaker function immediately after the procedure but may become evident at a later time resulting in pacing system malfunction or failure Prevention of Leakage Current Conduction Pulse generators and testing equipment connected to the lead must be battery powered Proper grounding of line powered devices in the vicinity of the patient is essential to prevent leakage currents arising from such devices to be conducted via the lead s terminal or any other non insulated part Necessary Equipment for Implantation During implantation the ECG should be recorded a pacing system analyzer PSA and defibrillation equipment should always be readily available Handling the Lead The lead should be handled very carefully at all times Any severe application of force bending stretching crimping etc may permanently damage
12. recommendations intended to provide optimally timed CRT Electronic Repositioning with 6 configurations with bipolar leads BiV Trigger and VRR Rhythm ID and OBDE inthe same device Programmable shock vectors Li MnO battery for extended longevitv and fast consistent charge times over the life of the device Respiratory rate trend 2 zone nominals Indications based programming 17 minutes of EGM storage 3 channels on As compared with previous Boston Scientific devices Energy Warranty Volume Thickness Product Description Model J years cc mm Diagram LIVIAN SmartDelay algorithm for 31 40 IS 1 quick AV delay programming 31 40 IS 1 LV 1 recommendations intended to LIVIAN HE provide optimallv timed CRT 41 44 IS 1 BiV Trigger and VRR 41 44 IS 1 LV 1 Compatible with LATITUDE Patient Management System Electronic Repositioning Stored EGMs with Onset Advanced battery technology Product CONTAK RENEWAL 3 CONTAK RENEWAL 3 HE Description Independent channels for right and left ventricular pacing and sensing Patient centric diagnostics HRV Monitor Footprint ABM HRV Monitor Trending Activity Log High energy output VRR Fast charge time Daily measurements Energy Warranty Model J years 31 342 31 Volume Thickness cc mm Header 3 3 40 40 Diagram Energy Warranty Thickness Product Description Model J years mm Header Diagra
13. the lead The metal portion of the lead connector should not be touched Lead Pulse Generator Compatibility Because of the numerous available 3 2 mm configurations e g the IS 1 and VS 1 standards lead pulse generator compatibility should be confirmed with the pulse generator and or lead manufacturer prior to the implantation of a pacing system Extending Retracting the Fixation Helix In the event of previous handling or repositioning of the lead more than the minimum number of rotations may be necessary to fully extend or retract the helix Full helix extension should always be verified through fluoroscopy Chronic Repositioning It is generally recommended that a chronically implanted endocardial lead not be explanted Chronic repositioning or removal of active fixation leads may be difficult due to the presence of blood or fibrotic tissue in the helix If it becomes necessary to remove the lead without successfully retracting the fixation helix the lead should be rotated counter clockwise during withdrawal in order to minimize the risk of endothelial laceration If it becomes necessary to abandon a lead the connector pin should be capped to prevent the transmission of electrical signals to the heart Suture Sleeve Always use a suture sleeve when implanting a lead Use of the suture sleeve which is provided with the lead will lessen the possibility of lead dislodgment and protect the lead body from damage by a securing ligature Potential A
14. tip he matoma seroma inappropriate or inability to provide therapy shocks pacing sensing infection procedure related psychologic intolerance to an ICD system patients susceptible to frequent shocks despite antiarrhythmic medical management imagined shocking and component failure In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev K Dielines do not print CRT P Systems and Leads from Boston Scientific CRM Indications Cardiac resynchronization therapy pacemakers CRT Ps are indicated for patients who have moderate to severe heart failure NYHA Class III IV including left ventricular dysfunction EF lt 35 and ORS duration 2 120 ms and remain symptomatic despite stable optimal heart failure drug therapy as defined in the clinical trials section in the System Guide The devices provide atrial ventricular tracking modes to help preserve AV synchrony and adaptive rate pacing for patients who would benefit from adjusted pacing rates concurrent with physical activity Left ventricular coronary venous steroid eluting pace sense leads are transvenous leads intended for chronic LV pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator Extended bipolar pacing and sensing is available using dual electrode LV leads with an RV pace sense defibrillation lead
15. tip may cause tissue damage Precautions For information on precautions refer to the following sections of the PG product labeling clinical considerations sterilization storage and handling implant and device programming follow up testing explant and disposal environmental and medical therapy hazards hospital and medical environment home and occupational environments Advise patients to avoid sources of electromagnetic interference EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy Refer to the following sections of the lead product labeling sterilization and handling and lead evaluation and implantation for cautions specific to handling implanting and testing the lead Failure to observe these cautions could result in incorrect lead implantation lead damage dislodgment or harm to the patient It has not been determined whether the warnings precautions or complications usually associated with injectable dexamethasone acetate apply to the use of the low concentration highly localized controlled release device For a listing of potentially adverse effects refer to the Physician s Desk Reference Potential Adverse Events Potential adverse events from implantation of the CRT D system include but are not limited to the following allergic physical physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead
16. II STEROX EZ 4turns 55D poly 55D Poly Active Fixation 6 turns silicone 55D Poly IROX coated tip electrode 99D Poly Thin co radial design Silicone Silicone 1S 1 Silicone Steroid elution Bipolar FINELINE II STEROX Preformed J 55D Poly ATRIAL J IROX coated tip electrode 99D Poly Passive Fixation Thin co radial design IS 1 Steroid elution Bipolar Tined fixation FINELINE II STEROX IROX coated tip electrode 55D Poly Passive Fixation Thin co radial design 55D Poly BER Silicone Steroid elution Silicone Bipolar Tined fixation Pacing Leads Product DEXTRUS Active Fixation FLEXTEND Active Fixation Description Extendable retractable 8 turns minimum ridium coated tip electrode NEO Steroid elution Bipolar Extendable retractable 6 8 turns IS 1 Steroid elution Bipolar Model 4135 4136 4137 Pacing Leads Length cm Insulation Diagram Silicone Silicone Silicone Silicone Silicone Silicone Product Lead Adapter Sleeve 1 3 2 mm low profile or IS 1 unipolar connector Lead Adapter 1 3 2 mm low profile or IS 1 bipolar connector Lead Adapter 6018 1 6 1 mm unipolar connector Lead Adapter 1 4 75 mm unipolar connector Lead Adapter Sleeve 1 3 2 mm low profile or IS 1 connector Lead Adapter u 2 4 75 mm connectors Uses 2 unipolar4 75 mm or 1 Bif Bipolar 4 75 mm Length cm 1 5 mm unipolar terminal 1 4 75 mm bi
17. Longevity projection as described in user manual Settings 60 ppm A 2 5 V V 2 5 V 500 ohms 100 paced MV Blended Sensor ON Onset EGMS ON 3 Longevity projection as described in user manual Settings 60 ppm A 2 5 V V 2 5 V 500 ohms 100 paced Accelerometer Sensor ON Onset EGMS ON Pacemakers Energy Warranty Volume Thickness Product Description J years cc mm Header Diagram TELIGEN Safety Core and Safety Architecture 1 Quick Convert Rhythm ID and OBDE inthe same device 2 zone nominals AV Search up to 400 ms Li MnO battery for extended longevitv and fast consistent charge times over the life of the device Programmable shock vectors Indications based programming Respiratory rate trend 17 minutes of EGM storage 3 channels on Ventricular Rate Regulation 31 5 9 9 DF 1 IS 1 31 5 9 9 DF 1 IS 1 ili CONFIENT 400 ms AV Delay AV Search Hysteresis Compatible with LATITUDE Patient Management System Stored EGMs w Onset Ventricular Rate Regulation Advanced battery technology As compared with previous Boston Scientific devices Product VITALITY 2 VITALITY 2 EL VITALITY AVT ICDs Energy Warranty Volume Thickness Description Model Type J years cc mm Header Diagram Rhythm ID T165 DR 31 30 DF 1 IS 1 AV Search Hysteresis DR only 1175 VR 31 30 DF 1 IS 1 Ventricular Rate Regulation FullView Stored EGMs w Onset Interval Graph M
18. RAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads Intended use and features Catheter shape gains support from the SVC to provide access to the CS and branch vein for guide wire and direct lead delivery Catheter shape gains support from the SVC to provide access to the CS and branch vein for guide wire and direct lead delivery Catheter shape gains support from the SVC to provide right sided access to the CS for guide wire and lead delivery units per package Diagram Product RAPIDO Cut Away Coronary Sinus Extended Hook Straight Right CS EH ST R guide catheter 7521 Working length 42 cm Overall length 48 cm 1564 Working length 47 cm Overall length 53 cm RAPIDO Cut Away Coronary Sinus Multi Purpose Hook CS MP guide catheter 1554 Working length 42 cm Overall length 48 cm 1555 Working length 47 cm Overall length 53 cm RAPIDO Cut Away Coronary Sinus Multi Purpose Hook CS MPH guide catheter 1558 Working length 42 cm Overall length 48 cm 7559 Working length 47 cm Overall length 53 cm Description 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of lead
19. Scientific C R M P FO d u ct G ul d e Delivering what s next Pacing Defibrillation and Cardiac Resynchronization Therapy December 2008 Dielines do not print Pacing Pulse Generators A A tette tnter ta tete tasas satt sata sa tasa stata sata sse rasa sata soto rrenaren aa 5 Defibrillation Pulse Generators Implantable Cardioverter Defibrillators ICDS un nenn 7 Cardiac Resynchronization Therapy Pulse Generators Cardiac Resynchronization Therapy Defibrillators CRT Ds sss 11 Cardiac Resynchronization Therapy Pacemakers CHT Pei 17 Pacing Leads and Accessories o A 19 Pacing Lead ACCESSONICS aaa AA 21 ECO AA 23 Defibrillation Leads and Accessories Defibrillation TL E 25 Defibrillation Lead AOGOSSOFHTES en un 27 Defibrillation Lead Gtvlerts ENEE 31 Cardiac Resynchronization Therapy Leads and Accessories A A e A PR 33 TA A TE 35 CCC re EE 41 Eet 46 E E 48 AA A 50 Freguentiy KO PAH AA AA 52 PAGA UA AGA TE 54 Eon A pa 56 The LATITUDE Patient Management system is compatible with virtually all Boston Scientific ICD and CRT D devices LATITUDE Wanded Communicator Model 6481 CONTAK CD 2 VENTAK PRIZM VR VITALITY DS VR H119 CONTAK CD 2 HE 1852 VENTAK PRIZM VR HE T125 VITALITY DS DR H135 CONTAK RENEWAL 1857 VENTAK PRIZM VR HE 1127 VITALITY EL DR H170 CONTAK RENEWAL 3 1860 VENTAK PRIZM 2 VR 1180 VITALITV HE H175 CONTAK RENEWAL 3 1851 VENTAK PRIZM DR 1165 VITALITV 2 DR H177
20. ated in Patients whose ventricular tachyarrhythmias may have reversible cause such as 1 digitalis intoxication 2 electrolyte imbalance 3 hypoxia or 4 sepsis or whose ventricular tachyarrhythmias have a transient cause such as 1 acute myocardial infarction 2 electrocution or 3 drowning Patients who have a unipolar pacemaker ICD leads are contraindicated in patients with a hypersensitivity to a single dose of approximately 1 0 mg of dexamethasone sodium phosphate and or 1 0 mg of dexamethasone acetate or patients with mechanical tricuspid heart valves Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system Such damage can result in patient injury or death Program the pulse generator ventricular Tachy Mode to Off during implant explant or post mortem procedures to avoid inadvertent high voltage shocks Always have sterile external and internal defibrillator protection available during implant If not terminated in a timely fashion an induced tachyarrhythmia can result in the patient s death Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation CPR are present during post implant device testing should the patient require external rescue Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device including area protected by a warnng notice that
21. ation of the ICD lead system include but are not limited to the following allergic physical physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead tip hematoma seroma inappropriate or inability to provide therapy shocks pacing sensing infection procedure related psychologic intolerance to an ICD system patients susceptible to frequent shocks despite antiarrhythmic medical management imagined shocking and component failure In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev H Dielines do not print CRT D Systems and Leads from Boston Scientific CRM Indications Cardiac Resynchronization Therapy Defibrillators CRT Ds are indicated for patients with moderate to severe heart failure NYHA III IV who remain symptomatic despite stable optimal heart failure drug therapy and have left ventricular dysfunction EF lt 35 and ORS duration 120 ms Left ventricular coronary venous steroid eluting pace sense leads are transvenous leads intended for chronic LV pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator Extended bipolar pacing and sensing Is available using dual electrode LV leads with an RV pace sense defibrillation lead or a bipolar RV pace sense lead Contraindi
22. ause structural weakness conductor discontinuity or lead dislodgment When using a finishing wire accessory kit use the corresponding finishing wire model for the lead length If the wrong length finishing wire is used the finishing wire tip may extend out of the distal end of the lead or not stabilize the lead properly When placing the lead with a stylet use only a stylet designed for use with the ACUITY Steerable lead These stylets are specifically designed to prevent the stylet from extending past the lead tip Extending the stylet past the lead tip may cause tissue damage Do not kink twist or braid the lead terminal with other leads as doing so could cause lead insulation abrasion or conductor damage Precautions For information on precautions refer to the following sections of the PG product labeling clinical considerations sterilization storage and handling implantation and device programming pulse generator explant and disposal environmental and medical therapy hazards hospital and medical environments home and occupational environments Advise patients to avoid sources of electromagnetic interference EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy Refer to the following sections of the lead product labeling sterilization and handling and lead evaluation and implantation Failure to observe these cautions could result in incorrect lead implantation lead damage dislodgment a
23. ble dexamethasone sodium phosphate acetate apply to the use of the low concentration highly localized controlled release device For a listing of potentially adverse effects refer to the Physician s Desk Reference Potential Adverse Events Potential adverse events from implantation of the pacing system include but are not limited to the following allergic physical physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead tip hematoma seroma inappropriate or inability to provide therapy pacing sensing infection procedure related and component failure In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev J Dielines do not print ICD Systems and Leads from Boston Scientific CRM ICD Lead Indications and Usage ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias ICDs with atrial therapies are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias ICD leads provide pacing and rate sensing and deliver cardioversion and defibrillation shocks for ICD systems Contraindications ICD systems are contraindic
24. cations There are no contraindications for the CRT D device Use of LV leads are contraindicated in patients with a hypersensitivity to a nominal dose of 0 45 0 7 or 1 0 mg dexamethasone acetate drug Some LV lead models are contraindicated in patients with mechanical tricuspid heart valves or obstructed or inadequate vasculature for intravenous catheterization Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system Such damage can result in patient injury or death Program the pulse generator Tachy Mode to Off during implant explant or postmortem procedures to avoid inadvertent high voltage shocks Always have sterile external and internal defibrillator protection available during implant If not terminated in a timely fashion an induced tachyarrhythmia can result in the patient s death Ensure that an external defibrillator and medical personnel skilled in CPR are present during post implant device testing should the patient require external rescue Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device including area protected by a warnng notice that prevents entry by patients who have a pulse generator Do not expose a patient to MRI device scanning Strong magnetic fields may damage interfere with the device and lead system and cause injury to the patient Do not subject a patient with an implanted p
25. cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER HI TORQUE WHISPER VIEW ES CS J 014 guide wire 4635 190 cm Extra support Parabolic ground core for transitionless profile Hydrocoat hydrophilic coating plus polymer on distal 30 cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER Guide Wires units per Intended use and features package Diagram Aids in selective placement of compatible LV leads e Easy access to distal anatomy e Core to tip design e Increased radiopacity e Gradual increase to extra support TT Aids in selective placement of compatible LV leads Easy access to distal anatomy e Core to tip design e Increased radiopacity e Gradual increase to extra support Guide Wires Product HI TORQUE WHISPER VIEW DS 014 guide wire 4636 190 cm HI TORQUE WHISPER VIEW DS CS J 014 guide wire 4637 190 cm Description Distal support Parabolic ground core for transitionless profile Hydrocoat hydrophilic coating plus polymer on distal 30 cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER Distal support Parabolic ground core for transitionless profile Hydrocoat hydrophilic c
26. dverse Events Potential complications resulting from the use of endocardial leads include but are not limited to thrombosis embolism body rejection phenomena cardiac tamponade pneumothorax muscle nerve stimulation valve damage fibrillation infection skin erosion ventricular ectopv and death Lead perforation through the myocardium has been rarely observed In rare cases severe complications or device failures can occur Refer to the physician s manual s for specific indications contraindications warning precautions and adverse events Rx only Rev C Dielines do not print Guide Wires Finishing Wires and Other Implant Accessories Refer to the product labeling for specific indications intended uses contraindications warnings precautions and adverse events Rx only Dielines do not print Dielines do not print Dielines do not print S Boston cientific Delivering what s next Cardiac Rhythm Management Boston Scientific Corporation 4100 Hamline Avenue North St Paul MN 55112 5798 USA Tel 651 582 4000 Fax 651 582 4166 Medical Professionals 1 800 CARDIAC 227 3422 Patients and Families 1 866 484 3268 www bostonscientific com Copyright 2008 by Boston Scientific Corporation or its affiliates All rights reserved C8 436 1208
27. furcated bipolar terminal 1 3 2 mm low profile unipolar terminal 1 3 2 mm low profile unipolar terminal 1 6mm unipolar terminal 1 IS 1 bipolar terminal Diagram Pacing Lead Accessories Product Lead Cap Kit Lead Adapter Sleeve Lead Cap Kit Lead Adapter Lead Extender Adapter IS 1 Port Plug 1 2 3 2 mm or 2 4 75 mm connectors 2 4 75 mm connectors 2 4 75 mm connectors 1 1S 1 or 3 2 mm low profile bipolar connector 1 IS 1 or 3 2 mm low profile bipolar connector 1 6 mm terminal 1 IS 1 bipolar terminal 1 IS 1 bipolar terminal 2 IS 1 terminals Length cm Pacing Lead Accessories Diagram Pacing Stylets Diameter in Length cm Length Firmness Model Knob Color Cap Color cm Green Red Type Type Straight 52 oft White Firm Atrial J Wide Atrial J Sus irm White Straight oft Straight Atrial J irm 6058 al Atrial J EE ide Atrial J Atrial J Straight oft Atrial J c Atrial Atrial Straight 6507 White Soft c Atrial White Straight 52 Atrial J TI DESEN DESEN DOLO e en om Ta e om om om DOLG o om om om DOG COC Pacing Lead Stylets Firmness Diameter in Model Knob Color Cap Color 6508 White 23 Pacing Lead Stylets FINELINE Stylets Length Diameter Knob Length Diameter Type cm Firmness in Model Color Cap Color
28. ipolar leads because a bipolar lead is required in either the atrium or the ventricle for MV detection single chamber atrial pacing in patients with impaired AV nodal conduction atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias which might trigger ventricular pacing dual chamber and single chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias asynchronous pacing in the presence or likelihood of competition between paced and intrinsic rhythms Pacing leads from BSC CRM are also contraindicated in patients with a hypersensitivity to a single dose of approximately 1 0 mg of dexamethasone sodium phosphate and or 1 0 mg of dexamethasone acetate patients with tricuspid valvular disease patients with mechanical tricuspid heart valves patients with an allergy to mannitol Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system Such damage can result in patient injury or death Inappropriate sustained high rate pacing occurred in the PULSAR MAX clinical study in 5 out of 130 patients with MV ON 4 to 14 days after implant If sustained high rate pacing could be of concern consider programming a reduced Max Sensor Rate or MV to Passive These programming recommendations are intended to assure that MV calibration is evaluated and if necessary recalibrated 4 ON when the patient and pacing system have stabilized post implant Continued monit
29. istal anatomy e Core to tip design e Increased radiopacity e Gradual increase to extra distal support Cc mm i NAA 11177 Aids in selective placement of compatible LV leads e Easy access to distal anatomy e Core to tip design e Increased radiopacity e Gradual increase to extra distal support Product HI TORQUE IRON MAN guide wire 6725 190 cm 035 Hydrophilic guide wire 6411 180 cm Description Extra support Stainless steel core Microglide hydrophobic coating on distal 30 cm Manufactured and labeled by Lake Region Manufacturing Inc 035 hydrophilic coated guide wire Performed angled tip Compatible torque device included units per Intended use and features package Diagram Aids in selective placement of EASYTRAK family of leads e Extreme vessel straightening e Core to tip design Facilitates placement of the catheter during left ventricular lead implant procedure e Coating durability for multiple insertions withdrawals eNitinol core designed to provide excellent kink resistance e 1 1 torque control to enable vessel naviga tion e Radiopaque polymer jacket for enhanced visualization e Preformed angled tip for steering and subselection Product FINISHING WIRE SUPPORTRAK LV 1 6681 65 cm 6682 72 cm 6683 80 cm 6684 90 cm 6685 100 cm FINISHING WIRE SUPPORTRAK IS 1 6667 80 cm 6668 90 cm 6669 100 cm Description
30. m CONTAK RENEWAL 3 RF Independent channels for right 31 3 2 14 and left ventricular pacing and 31 14 sensing Patient centric diagnostics CONTAK RENEWAL 3 RF HE Patient triggered monitor Heart rate variability HRV Monitor Footprint Automatic Balance Monitor ABM HRV Monitor Trending Activity Log Snapshot viewer Ventricular Rate Regulation Fast charge time Daily measurements Enhanced telemetry communication with ZIPTM wandless telemetry Energy Warranty Volume Thickness Description Model J years cc mm Header Product Diagram CONTAK RENEWAL Independent channels for right and left ventricular pacing and sensing Patient centric diagnostics Heart rate variability HRV Monitor Footprint HRV Monitor Trending Activity Log um Ventricular Rate Regulation Cragg RENEWAL Warranty Volume Thickness Product Description Model years cc mm Header Diagram CONTAK RENEWAL TR Independent channels for 5 8 5 IS 1 right and left ventricular 8 5 LV 1 pacing and sensing Patient centric diagnostics Heart rate variability HRV Monitor Footprint HRV Monitor Trending Activity Log Ventricular Rate Regulation Daily measurements 110 sec EGM storage Due to variations among introducer manufacturers please call CRM Technical Services at 1 800 CARDIAC for specific recommendations regarding introducer sizes Length Product Description Model cm Insulation Diagram FINELINE
31. nd or harm to the patient It has not been determined whether the warnings precautions or complications usually associated with injectable dexamethasone acetate apply to the use of the low concentration highly localized controlled release device For a listing of potentially adverse effects refer to the Physician s Desk Reference Potential Adverse Events Potential adverse events from implantation of the CRT P system include but are not limited to the following allergic phvsical phvsiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fracture insulation lead tip hematoma seroma inappropriate or inability to provide therapy pacing sensing infection lead tip deformation and or breakage procedure related and component failure In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev H Dielines do not print RAPIDO Cut Away and RAPIDO ADVANCE Guiding Catheter Systems from Boston Scientific CRM Indications for Use The Guidant RAPIDO Cut Away and RAPIDO ADVANCE guiding catheters are intended to access the coronary venous system and may be used as a dual catheter assembly The catheter serves as a conduit for the delivery of contrast medium and devices including implantable coronary venous leads introduced into the coronary venous system
32. o a component failure and device malfunction When using a RV pace sense lead in conjunction with an LV pacing lead it is recommended that a polyurethane insulated lead be used Failure to observe this warning could result in insulation damage of the RV lead which can cause a periodic or continual loss of pacing sensing or both Lead fracture dislodgment abrasion or an incomplete connection can cause a periodic or continual loss of pacing sensing or both The use of battery powered equipment is recommended during lead implantation and testing to protect against fibrillation that might be caused by leakage currents Line powered equipment used in the vicinity of the patient must be properly grounded The lead connector must be insulated from any leakage currents that could arise from line powered equipment The lead is not designed to tolerate excessive flexing bending tension or injection pressure This could cause structural weakness conductor discontinuity or lead dislodgment When using a finishing wire accessory kit use the corresponding finishing wire model for the lead length If the wrong length finishing wire is used the finishing wire tip may extend out of the distal end of the lead or not stabilize the lead properly When placing the lead with a stylet use only a stylet designed for use with the ACUITY Steerable lead These stylets are specifically designed to prevent the stylet from extending past the lead tip Extending the stylet past the lead
33. oating plus polymer on distal 30 cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER units per Intended use and features package Aids in selective placement of compatible LV leads e Easy access to distal anatomy e Core to tip design Increased radiopacity e Gradual increase to distal support Aids in selective placement of compatible LV leads e Easy access to distal anatomy e Core to tip design e Increased radiopacity e Gradual increase to distal support Diagram as 1 M Il Product HI TORQUE WHISPER VIEW EDS 014 guide wire 4638 190 cm HI TORQUE WHISPER VIEW EDS CS J 014 guide wire 4639 190 cm Description Extra distal support Parabolic ground core for transitionless profile Hydrocoat hydrophilic coating plus polymer on distal 30 cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER Extra distal support Parabolic ground core for transitionless profile Hydrocoat hydrophilic coating plus polymer on distal 30 cm Enhanced radiopacity for exceptional visualization 36 brighter at the tip and 360 brighter proximal to the tip when compared to WHISPER units per Intended use and features package Diagram Aids in selective placement of compatible LV leads e Easy access to d
34. or a bipolar RV pace sense lead Contraindications These devices are contraindicated in patients who have a separate implanted cardioverter defibrillator ICD Single chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction Atrial tracking modes are contraindicated for patients with chronic refractory atrial tachyarrhythmias atrial fibrillation or flutter which might trigger ventricular pacing Asynchronous pacing is contraindicated in the presence or likelihood of competition between paced and intrinsic rhythms Use of LV leads are contraindicated in patients with a hypersensitivity to a nominal dose of 0 45 0 7 or 1 0 mg dexamethasone acetate drug Some LV lead models are contraindicated in patients with mechanical tricuspid heart valves or obstructed or inadequate vasculature for intravenous catheterization Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system Such damage can result in patient injury or death Do not kink the leads Kinking leads may cause additional stress on the leads possibly resulting in lead fracture Do not expose a patient to MRI device scanning Strong magnetic fields may damage interfere with the device and lead system and cause injury to the patient Do not expose a patient with an activated implanted pulse generator and lead system to diathermy Therapeutic diathermy may cause fibrillation burning of the myocardium and irrever
35. oring of the MV sensor performance should be performed at all follow up visits until implant stabilization has occurred The use of battery powered equipment Is recommended during lead implantation and testing to protect against fibrillation that might be caused by alternating currents Line powered equipment used in the vicinity of the patient must be properly grounded The lead connector must be insulated from any leakage currents that could arise from line powered equipment Precautions For information on precautions refer to the following sections of the PG product labeling clinical considerations sterilization storage and handling lead evaluation and connection implantation programming and pacemaker operation MV initialization environmental and medical therapy hazards Advise patients to avoid sources of electric or magnetic interference EMI If the pacemaker inhibits or reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation Refer to the lead product labeling for cautions specific to handling implanting and testing the lead Failure to observe these cautions could result in incorrect lead implantation lead damage dislodgment or harm to the patient It has not been determined whether the warnings precautions or complications usually associated with injecta
36. patible with the LATITUDE system For contraindications for use related to the pulse generator refer to the System Guide for the pulse generator being interrogated Precautions The LATITUDE system is designed to notify clinicians within 24 hours if new pulse generator alert conditions are detected by the Communicator Pulse generator data will typically be available for review on the LATITUDE system within 15 minutes of a successful interrogation However data availability and alert notification can take up to 24 hours or the next business day Note that data will not be available and alert notification cannot occur if e The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line e The pulse generator and the Communicator cannot establish and complete a telemetry session This session must be initiated by the patient if he or she has a pulse generator that uses inductive telemetry e The Communicator becomes damaged or it malfunctions Up to two weeks may elapse before LATITUDE first detects the conditions mentioned above and additional time may be required for notification and resolution of the condition During this time no new patient data device data or alert notifications since the last successful data transmission will be available Adverse Effects None known Refer to the product labeling for specific instructions for use Rx only Rev H Dielines do not print Pacing Systems and
37. prevents entry by patients who have a pulse generator Do not expose a patient to MRI device scanning Strong magnetic fields may damage the device and cause injury to the patient Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation burning of the myocardium and irreversible damage to the pulse generator because of induced currents Do not use atrial tracking modes or an AVT device in patients with chronic refractory atrial tachyarrhythmias Tracking of atrial arrhythmias could result in VT or VF Applies to dual chamber devices only Do not use this pulse generator with another pulse generator This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery Do not kink leads Kinking leads may cause additional stress on the leads possibly resulting in lead fracture For specific models when using a subpectoral implantation place the pulse generator with the serial number facing away from the ribs Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case potentially leading to a component failure and device malfunction Do not attempt to use the lead system with any device other than a commercially available ICD with which it has been tested and demonstrated safe and effective potential adverse consequences include but are not limited to unde
38. raid the lead terminals as doing so could cause lead insulation abrasion damage Precautions For information on precautions refer to the following sections of the ICD product labeling clinical considerations sterilization storage and handling implantation and device programming follow up testing explant and disposal environmental and medical therapy hazards hospital and medical environments home and occupational environments Advise patients to avoid sources of electromagnetic interference EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy Refer to the lead product labeling for cautions specific to handling implanting and testing the lead Failure to observe these cautions could result in incorrect lead implantation lead damage and or harm to the patient It has not been determined whether the warnings precautions or complications usually associated with injectable dexamethasone sodium phosphate acetate apply to the use of the low concentration highly localized controlled release device For a listing of potentially adverse effects refer to the Physician s Desk Reference Tricuspid valvular disease may be exacerbated by the presence of a lead Use medical judgment when deciding to place a lead in a patient with triscuspid valvular disease The lead and its accessories are intended only for one time use Do not reuse Potential Adverse Events Potential adverse events from implant
39. ronary venous system when used with an outer guide catheter e Offers flexibility during coronary sinus CS cannulation e Aids in deep seating outer catheter e Facilitates branch vein subselection e Enables selective venogram Provides access to the coronary venous system when used with an outer guide catheter e Offers flexibility during coronary sinus CS cannulation e Aids in deep seating outer catheter e Facilitates branch vein subselection e Enables selective venogram Diagram Guide Catheters Product RAPIDO ADVANCE Coronary Sinus Extended Hook CS EH guide catheter 7711 Working length 47 cm Overall length 53 cm 1112 Working length 52 cm Overall length 58 cm 1113 Working length 57 cm Overall length 63 cm RAPIDO ADVANCE Coronary Sinus Extended Hook Right CS EH R guide catheter 7714 Working length 47 cm Overall length 53 cm 7715 Working length 52 cm Overall length 58 cm 7716 Working length 57 cm Overall length 63 cm Description 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads Guide Catheters units per Intended use and features package Diagram Catheter shape gains support from the superior vena cava SVC to provide access to the CS and branch vein for guide wire and direct lead delivery
40. roscopic observation Precautions Prior to use the guiding catheter rotating hemostasis valve cutter and stopcock should be examined to verify functionality and ensure that their sizes and shapes are suitable for the specific procedure for which they are to be used It is recommended that a guide wire be used to advance the guiding catheter into the venous system right atrium or coronary sinus Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev F Dielines do not print DEXTRUS Pacing Leads from Boston Scientific CRM Indications The DEXTRUS transvenous steroid eluting active fixation endocardial leads are indicated for permanent pacing and sensing Active fixation pacing leads with a bipolar BP IS 1 connector configuration are designed for use in conjunction with implantable pulse generators with IS 1 headers The leads may be used with single or dual chamber pacing systems The DEXTRUS lead models are intended for placement in either the right atrium or right ventricle Contraindications Transvenous endocardial pacing leads are contraindicated in the presence of severe tricuspid valvular disease and in patients with mechanical tricuspid heart valves The DEXTRUS lead is additionally contraindicated for patients who cannot tolerate a single systemic dose of up to 1 3 mg of dexamethasone acetate DXA Warnings and Precautions Potentially Harmful Therapeutic
41. rsensing of cardiac therapy and failure to deliver necessary therapy The safety and efficacy of the tip electrode placement above midseptum has not been clinically established extendable retractable helix leads Lead fracture dislodgment abrasion and or incomplete connection can cause a periodic or continual loss of rate sensing possibly resulting in inappropriate delivery of a PG shock or inadequate delivery of converting energy The lead is not designed to tolerate excessive flexing bending or tension This could cause structural weakness conductor discontinuity and or lead dislodgment Failure to obtain appropriate electrode position may result in higher defibrillation thresholds or may render lead unable to defibrillate a patient whose tachyarrhythmia s might otherwise be convertible by an ICD system In order to deliver defibrillation therapy the single coil lead must be implanted with a separate defibrillation electrode BSC recommends using the single coil lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode When connecting the lead to ECD cables and or the ICD PG it is very important that proper connections are made Damage to the heart could result if a high voltage defibrillating pulse were to be delivered through the pace sense tip electrode Use of any component of the lead system to assist in the delivery of external source rescue shocks could cause extensive tissue damage Do not kink twist or b
42. s units per Intended use and features package Diagram Catheter shape gains support from the SVC to provide access to the CS for guide wire and lead delivery Catheter shape gains support from the right atrium to provide access to the CS for guide wire and lead delivery Catheter shape gains support from the right atrium to provide access to the CS for guide wire and lead delivery Product RAPIDO Cut Away Coronary Sinus Wide CS W guide catheter 7516 Working length 42 cm Overall length 48 cm 1560 Working length 47 cm Overall length 53 cm RAPIDO Cut Away Coronary Sinus Straight CS ST guide catheter 1599 Working length 42 cm Overall length 48 cm 7598 Working length 47 cm Overall length 53 cm Description 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads 0D 8F ID 6 6F 0 087 2 21 mm Compatible with IS 1 and LV 1 EASYTRAK family of leads units per Intended use and features package Diagram Catheter shape gains support from the SVC to provide access to the CS for guide wire and lead delivery Catheter shape gains support from the right atrium to provide access to the CS for guide wire and lead delivery Product HI TORQUE WHISPER VIEW ES 014 guide wire 4634 190 cm Description Extra support Parabolic ground core for transitionless profile Hydrocoat hydrophilic coating plus polymer on distal 30
43. s an LV 1 lead to an IS 1 lead port units per package Diagram Other Accessories Finishing Wire Compatibility Chart Lead 4517 EASVTRAK 2 IS 1 80 cm LV 1 4518 EASYTRAK 21S 1 90 cm LV 1 4520 EASYTRAK 2 IS 1 100 cm LV 1 4542 EASVTRAK 2 IS 1 80 cm 4543 EASVTRAK 2 1S 1 90 cm 4544 EASVTRAK 21S 1 100 cm 4524 EASVTRAK 3 IS 1 80 cm LV 1 4525 EASVTRAK 3 IS 1 90 cm LV 1 4527 EASYTRAK 3 IS 1 90 cm LV 1 4548 EASYTRAK 3 IS 1 80 cm 4549 EASVTRAK 3 IS 1 90 cm 4550 EASVTRAK 3 IS 1 100 cm 4554 ACUITY Steerable 80 cm 4555 ACUITY Steerable 90 cm 4591 ACUITY Spiral 80 cm 4592 ACUITY Spiral 90 cm Compatibility Charts SUPPORTRAK Finishing Wire 6667 6669 6683 6684 6685 6667 6668 6669 6683 6684 6685 6667 6668 6669 6667 6668 6667 6668 RAPIDO ADVANCE Guide Catheter Length to Lead Length Recommendation 8F RAPIDO ADVANCE working length 6F inner catheter compatibility Minimumrecommended EASYTRAK lead length 55 LATITUDE Patient Management System from Boston Scientific CRM Intended Use The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database Contraindications The LATITUDE system is contraindicated for use with any pulse generator other than a compatible pulse generator from Boston Scientific CRM Not all Guidant or Boston Scientific pulse generators are com
44. sense lead Over the wire design IROX electrode coating 1S 1 Steroid elution 3 dimensional spiral fixation CRT Leads Product EASYTRAK 2 EASYTRAK 2 EASYTRAK 3 EASYTRAK 3 Description Coronary venous pacing lead Over the wire design Steriod elution Tined fixation Coronary venous pacing lead Over the wire design IS 1 Steriod elution Tined fixation Coronarv venous pacing lead Over the wire design Steriod elution 3 dimensional spiral fixation Coronary venous pacing lead Over the wire design IS 1 Steriod elution 3 dimensional spiral fixation Model 4517 4518 4520 CRT Leads Length cm Terminal 80 LV 1 90 Polarity Diagram aa Ue AA A Product RAPIDO Coronary Sinus Inner Catheter 50 Compact CS IC 50C guide catheter 7720 Working length 79 cm Overall length 85 cm 7552 Working length 69 cm Overall length 75 cm RAPIDO Coronary Sinus Inner Catheter 90 CS IC 90 guide catheter 1121 Working length 79 cm Overall length 85 cm 6776 Working length 69 cm Overall length 75 cm Description Outer diameter OD 6 French F Inner diameter ID 4 9F 0 064 1 63 mm Compatible with RAPIDO ADVANCE and RAPIDO Cut Away 0D 6F ID 4 9F 0 064 1 63 mm Compatible with RAPIDO and RAPIDO Cut Away units per Intended use and features package Provides access to the co
45. sible damage to the pulse generator system because of induced currents Do not use atrial only modes in patients with heart failure because such modes do not provide CRT The clinical outcomes for patients with chronic refractory atrial tachyarrhythmias are not fully known Safety and effectiveness studies have not been conducted If a chronic refractory atrial tachyarrhythmia develops in a patient with these devices do not use dual chamber or single chamber atrial pacing Left ventricular LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition When using a RV pace sense lead in conjunction with an LV pacing lead it is recommended that a polyurethane insulated lead be used Failure to observe this warning could result in insulation damage of the RV lead which can Cause a periodic or continual loss of pacing sensing or both Lead fracture dislodgment abrasion or an incomplete connection can cause a periodic or continual loss of pacing sensing or both The use of battery powered equipment is recommended during lead implantation and testing to protect against fibrillation that might be caused by leakage currents Line powered equipment used in the vicinity of the patient must be properly grounded The lead connector must be insulated from any leakage currents that could arise from line powered equipment The lead is not designed to tolerate excessive flexing bending tension or injection pressure This could c
46. ulse generator and lead system to diathermy since diathermy may cause fibrillation burning of the myocardium and irreversible damage to the pulse generator because of induced currents Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias Tracking of atrial arrhythmias could result in VT or VF Do not use atrial only modes in patients with heart failure because such modes do not provide CRT LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition Physicians should use medical discretion when implanting this device in patients who present with slow VT Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones Do not kink leads Kinking leads may cause additional stress on the leads possibly resulting in lead fracture Do not use defibrillation patch leads with the CRT D system or injury to the patient may occur Do not use this pulse generator with another pulse generator This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery For specific models when using a subpectoral implantation place the pulse generator with the serial number facing away from the ribs Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case potentially leading t
47. y Patient Profile with Quick Profiles Rhythm ID T167 DR 35 DF 1 IS 1 AV Search Hysteresis DR only T177 VR 35 DF 1 IS 1 Ventricular Rate Regulation FullView Stored EGMs w Onset Interval Graph My Patient Profile with Quick Profiles Automatic Atrial ATP 30 DF 1 IS 1 Atrial Rhythm Classification SC CV Atrial Pacing Preference Cardioversion OO d ProACt f ae Ventricular Rate Regulation ai caca AN Search Hvsteresis num FullView Stored EGMs w Onset Shock If Unstable My Patient Profile Product VITALITY DS VITALITY EL VENTAK PRIZM HE AV Search Hysteresis DR only Energy efficient Episode Onset 3 channel Stored EGMs Shock If Unstable Energy Warranty Volume Model Type J AV Search Hysteresis T125 DR FullView Stored EGMs w Onset T135 VR Daily Measurements Shock If Unstable Patient triggered Monitor B VR Description years cc AV Search Hysteresis T127 FullView Stored EGMs w Onset Daily Measurements Shock If Unstable Patient triggered Monitor DR only DR Thickness mm Header Diagram DF 1 IS 1 DF 1 IS 1 DF 1 IS 1 DF 1 IS 1 6 1 mm 4 75 mm 6 1 mm 4 75 mm 15 1 atrial Energy Warranty Volume Thickness Product Description Model J years cc mm Header Diagram COGNIS Safety Core and Safety 5 32 5 9 9 IS 1 DF 1 LV 1 Architecture 5 32 5 9 9 IS 1 DF 1 1S 1 Quick Convert SmartDelay algorithm for quick AV delay programming

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