Boston Scientific Corporation · NYSE:BSX
Boston Scientific — Investor Presentation (January 2014)
62 slides from Boston Scientific's investor presentation, January 2014
Slide 1: Electrophysiology Products Corporate Overview
Electrophysiology Products Corporate Overview © © 2014 Boston Boston Scientific Scientific Corporation Corporation or its affiliates. or its affiliates. All rights All rights reserved. reserved. EP-222901-AA EP-222901-AA JAN2014 JAN2014
Slide 2: Redefining EP…Together
Redefining EP…Together © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014
Slide 3: EP…Redefining Ablation Technology
EP…Redefining Ablation Technology Leader in Performance EP Catheters* • Broad Rx and Dx Catheter product line • Blazer™ Temperature Ablation Catheter family Portfolio of Ablation Technology defining the new ‘gold standard’ of expectations • First family of catheters designed to give multi-dimensiona
Slide 4: Why Bard Electrophysiology? Diagnostic Catheters
Why Bard Electrophysiology? Diagnostic Catheters PRE-ACQUISITION POST-ACQUISITION Explorer 360™/Explorer ST™ Fixed-Curve Dx Catheters Blazer® Dx-20 Duodecapolar Diagnostic Catheter Blazer® Dx-20 Duodecapolar Diagnostic Catheter SteeroCath-Dx™ Steerable Diagnostic Catheter SteeroCath-Dx™ Steerable Di
Slide 5: Why Bard Electrophysiology? Capital Equipment
Why Bard Electrophysiology? Capital Equipment PRE-ACQUISITION POST-ACQUISITION Rhythmia™ Mapping System Rhythmia™ Mapping System Maestro 3000® Cardiac Ablation System Maestro 3000® Cardiac Ablation System CiruCool® Pump CiruCool® Pump iLab® Ultrasound Imaging System iLab® Ultrasound Imaging System L
Slide 6: Surrounding the EP Customer: Full Suite of Technology Solutions
Boston Scientific Electrophysiology Surrounding the EP Customer Rhythmia™ Mapping System Refreshed Core EP IntellaTip MiFi™ XP EP Systems Mapping Catheters Open-Irrigation Intracardiac Access Full Suite of Technology Solutions © Boston Scientific Corporation or its affiliates. All rights reserved. E
Slide 7: Full Suite of Technology Solutions
Product Overview Full Suite of Technology Solutions DIAGNOSING VISUALIZING ACCESSING TREATING REDEFINING Cardiac Arrhythmias Cardiac Anatomy Cardiac Anatomy Cardiac Arrhythmias Electrophysiology Diagnostic Catheters Rhythmia™ Fixed Curve Blazer™ IntellaTip MiFi™ XP Mapping System Sheaths Catheter Fa
Slide 8: Diagnosing Cardiac Arrhythmias
Diagnosing Cardiac Arrhythmias Fixed Curve Diagnostic Catheters Steerable Diagnostic Catheters Tango™ Stabilene™ Viking™ Diagnostic Viking™ Diagnostic Catheter Catheter Soft Tip Diagnostic Catheter Woven Diagnostic WovenFlexie™ Catheter Diagnostic Catheter © Boston Scientific Corporation or its affi
Slide 9: Diagnosing Cardiac Arrhythmias
Diagnosing Cardiac Arrhythmias Fixed Curve Diagnostic Catheters Steerable Diagnostic Catheters Blazer™ Dx-20 Dynamic Tip™ Dynamic XT EP•XT™ Bidirectional Duodecapolar Steerable Steerable Steerable Diagnostic Catheter Catheter Catheter Catheter Orbiter™ ST Polaris X™ Radia™ SteeroCath-Dx™ 20-Pole Ste
Slide 10: Diagnosing Cardiac Arrhythmias
Diagnosing Cardiac Arrhythmias Advanced Mapping Catheters CONFORMA™ Constellation™ Bidirectional Mapping Diagnostic Catheter Catheter IntellaMap Orion™ Orbiter™ PV Mapping Variable Loop Catheter Mapping Catheter © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN
Slide 11: Diagnosing Cardiac Arrhythmias
Diagnosing Cardiac Arrhythmias Recording Systems RF Generator LabSystem™ PRO CLEARSIGN™ EPLogix™ Mapping Maestro 3000™ Cardiac EP Recording System Amplifier and Ablation Generator Analysis Suite EPLink™ H.I.S. MicroPace MicroPace Interface StimCor™ StimLab™ Bedside Interface © Boston Scientific Corp
Slide 12: Visualizing Cardiac Arrhythmias
Visualizing Cardiac Arrhythmias Mapping and Ultrasound Rhythmia™ iLab™ Ultra ICE™ Mapping System Ultrasound Imaging Catheter Imaging System © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 13: Increase EP Lab Productivity
Visualizing Cardiac Arrhythmias Increase EP Lab Productivity The Rhythmia™ Mapping System delivers highly detailed maps in less time than conventional systems J&J Carto® XP System Rhythmia Mapping System Mapped Points: 253 Mapped Points: 3,658 Mapping Time: 38 minutes Mapping Time: 11 minutes Propri
Slide 14: Map the Heart in 1/3 of the Time
Visualizing Cardiac Arrhythmias Map the Heart in 1/3 of the Time © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 15: Every Minute Counts
Visualizing Cardiac Arrhythmias Every Minute Counts © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 16: The Impact on Your Bottom Line
Visualizing Cardiac Arrhythmias The Impact on Your Bottom Line © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 17: Accessing Cardiac Arrhythmias
Accessing Cardiac Arrhythmias Introducer Sheaths Transseptal Needle Channel DiRex™ TSX™ Steerable Sheath Steerable Sheath Transseptal Needle Zurpaz™ 8.5F HeartSpan™ Steerable Sheath Fixed Curve Braided Transseptal Sheath © Boston Scientific Corporation or its affiliates. All rights reserved. EP-2229
Slide 18: Treating Cardiac Arrhythmias
Treating Cardiac Arrhythmias Blazer Family IntellaTip™ Small Tip Blazer™ II Blazer™ II HTD Blazer Prime™ IntellaTip MiFi™ XP Temperature Ablation Temperature Temperature Catheter Catheter Ablation Catheter Ablation Catheter Family Cooled Ablation Large Tip Open-Irrigated Blazer™ II XP Blazer Prime™
Slide 19: IntellaTip MiFi XP Catheter
Treating Cardiac Arrhythmias Multi-sense Ablation Technology IntellaTip MiFi™ XP Catheter Unique Design 3 Sophisticated Mini-Electrodes • Enable localized recording of a small area • Deliver signals of unparalleled clarity • Allow multiple channels for highly localized EGMs Next © Boston Scientific
Slide 20: Accurate EGM Localization
Treating Cardiac Arrhythmias Accurate EGM Localization • EGMs with mini-electrodes provide accurate information of tip location • Mini-electrode electrograms clearly demonstrate when the tip enters the RA from the SVC¹ Next 1. Data on File. Results from case studies are not necessarily predictive of
Slide 21: IntellaTip MiFi XP System Components
Treating Cardiac Arrhythmias IntellaTip MiFi™ XP System Components IntellaTip MiFi™ XP Cables & Accessories Temperature Ablation Catheter © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 22: 2013 New Products Launched
Redefining Electrophysiology 2013 New Products Launched IntellaTip MiFi Rhythmia IntellaTip MiFi XP Catheter Rhythmia™ Mapping System Zurpaz Zurpaz™ 8.5F IntellaMap Orion™ Steerable Sheath Mapping Catheter Next © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2
Slide 23: 2014 Product Pipeline
Redefining Electrophysiology 2014 Product Pipeline 2014 OUS Launch US Launch OUS Launch OUS Launch IntellaTip MiFi™ OI Rhythmia™ IntellaTip OUS Launch Catheters* IntellaNav Gen 1 US Launch MiFi™ XP OI System MiFi™ OI IntellaNav XP OUS Launch US Launch Catheters* Catheters* Rhythmia™ Gen 1 OI System
Slide 24: 2015 Product Pipeline
Redefining Electrophysiology 2015 Product Pipeline OUS/US Launch LabSystem PRO NextGen 2015 OUS Launch IntellaNav XP OUS/US Launch Rhythmia Gen 2 OUS/US Launch IntellaMap Gen 2 US Launch IntellaTip MiFi™ OI Catheters* *Investigation device limited by federal law to investigational use only. Not avai
Slide 25: Abbreviated DFUs
Abbreviated DFUs © Boston Scientific Corporation or its affiliates. All rights reserved. EP-222901-AA JAN2014 Main Menu
Slide 26: Blazer II and Blazer II HTD Temperature Ablation Catheters (US DFU)
Blazer® II and Blazer® II HTD Temperature Ablation Catheters (US DFU) Indication for Use* When using the Blazer II Catheter/Blazer II HTD Catheters: The Boston Scientific Cardiac Ablation System is indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia. Con
Slide 27: Blazer II and Blazer II HTD Temperature Ablation Catheters (US DFU)
Blazer® II and Blazer® II HTD Temperature Ablation Catheters (US DFU) Precautions (cont’d) • The Boston Scientific Blazer II Temperature Ablation Catheter and Blazer II HTD Catheters are intended for use with the EPT-1000™ Cardiac Ablation System Controller and accessories or the Maestro 3000® Contr
Slide 28: Blazer II XP Temperature Ablation Catheter (US DFU)
Blazer® II XP Temperature Ablation Catheter (US DFU) Indication for Use* The Boston Scientific Corporation Blazer II XP Catheter is indicated for use with the BSC high power Cardiac Ablation Controllers (the Maestro 3000® Controller, the EPT-1000XP™ Controller, and the EPT-1000XPT™ Controller) and A
Slide 29: Blazer II XP Temperature Ablation Catheter (US DFU)
Blazer® II XP Temperature Ablation Catheter (US DFU) Precautions • Observe these precautions, before using the device: • Do not attempt to operate the Controller before thoroughly reading the appropriate BSC high power Cardiac Ablation Controller & Accessories Operator’s Manual. • The Blazer II XP C
Slide 30: Blazer II XP Temperature Ablation Catheter (US DFU)
Blazer® II XP Temperature Ablation Catheter (US DFU) Adverse Events Potential Adverse Events Potential adverse events (in alphabetical order), that may be associated with cardiac catheterization and ablation include, but are not limited to: • allergic reaction (including anaphylaxis) • angina • arrh
Slide 31: Blazer Prime HTD Temperature Ablation Catheters (US DFU)
Blazer Prime® HTD Temperature Ablation Catheters (US DFU) Indication for Use* When using the Blazer Prime HTD Catheter: The Boston Scientific Cardiac Ablation System is indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia. Contraindications The use of the
Slide 32: Blazer Prime HTD Temperature Ablation Catheters (US DFU)
Blazer Prime® HTD Temperature Ablation Catheters (US DFU) Precautions (cont’d) • The Boston Scientific Blazer Prime HTD Catheter is intended for use with the EPT-1000™ Controller and accessories or the Maestro 3000® Controller and accessories only. • Do not attempt to operate the BSC Cardiac Ablatio
Slide 33: Blazer Prime XP Temperature Ablation Catheter (US DFU)
Blazer Prime® XP Temperature Ablation Catheter (US DFU) Indication for Use* The Boston Scientific Corporation Blazer Primer XP Catheter is indicated for use with the BSC high power Cardiac Ablation Controllers (the Maestro 3000® Controller, the EPT-1000XP™ Controller, and the EPT-1000XPT™ Controller
Slide 34: Blazer Prime XP Temperature Ablation Catheter (US DFU)
Blazer Prime® XP Temperature Ablation Catheter (US DFU) Adverse Events Potential Adverse Events Potential adverse events (in alphabetical order), that may be associated with cardiac catheterization and ablation include, but are not limited to: • allergic reaction (including anaphylaxis) • angina • a
Slide 35: Chilli II Cooled Ablation Catheter (US DFU)
Chilli II® Cooled Ablation Catheter (US DFU) Indication for Use* The Chilli II® Cooled Ablation System is indicated for: • cardiac electrophysiological mapping • delivering diagnostic pacing stimuli • radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease
Slide 36: Chilli II Cooled Ablation Catheter (US DFU)
Chilli II® Cooled Ablation Catheter (US DFU) Precautions (cont’d) • Use only dispersive electrodes that meet or exceed EN 60601-1 requirements and follow the dispersive (grounding) electrode manufacturer’s instructions for use. • Do not increase power before checking for lead connection and appropri
Slide 37: Blazer Open-Irrigated Temperature Ablation Catheter (EU DFU)
Blazer® Open-Irrigated Temperature Ablation Catheter (EU DFU) INDICATIONS FOR USE The Blazer Open-Irrigated Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for car
Slide 38: Blazer Open-Irrigated Temperature Ablation Catheter (EU DFU)
Blazer® Open-Irrigated Temperature Ablation Catheter (EU DFU) Warnings (cont’d) • Warnings for patients with implantable pacemakers and implantable cardioverter/ defibrillators (ICDs): - Follow manufacturer guidelines for ICD programming during RF ablation as RF ablation may result in underdetection
Slide 39: Blazer Open-Irrigated Temperature Ablation Catheter (EU DFU)
Blazer® Open-Irrigated Temperature Ablation Catheter (EU DFU) Warnings (cont’d) • Pre-procedural anticoagulation therapy is at the discretion of the physician. However, patients with a history of thromboembolic events may require therapeutic anticoagulation therapy, pre-, during and post-ablation to
Slide 40: Polaris X Diagnostic Catheter (US DFU)
Polaris X™ Diagnostic Catheter (US DFU) Device Description The Boston Scientific diagnostic catheters are designed for use in intracardiac pacing and recording only. The catheters have been designed to carry electrical signals for the purpose of endocardial stimulation (pacing) or recording. The Pol
Slide 41: SteeroCath-Dx Steerable Diagnostic Catheter (US DFU)
SteeroCath-Dx™ Steerable Diagnostic Catheter (US DFU) INDICATIONS FOR USE The catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. CONTRAINDICATIONS Caution should be exercised, in the use of this or any
Slide 42: Blazer Dx-20 Bidirectional Duodecapolar Diagnostic Catheter (US DFU)
Blazer® Dx-20 Bidirectional Duodecapolar Diagnostic Catheter (US DFU) Indication for Use The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies intracardiac stimulation (pacing) and/or recording of electrical potentials. Contraindications • Caution should be exercised,
Slide 43: Constellation Mapping Catheter (US DFU)
Constellation® Mapping Catheter (US DFU) Indication for Use* For use in the right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multi
Slide 44: Ultra ICE Imaging Catheter (US DFU)
Ultra ICE™ Imaging Catheter (US DFU) Intended Use/Indications for Use The Ultra ICE Rounded Tip Catheter is indicated for enhanced ultrasonic visualization of intracardiac structures. Contraindications • This product is contraindicated in the presence of conditions which create unacceptable risk dur
Slide 45: HeartSpan Braided Fixed Curve Transseptal Sheath (US DFU)
HeartSpan™ Braided Fixed Curve Transseptal Sheath (US DFU) Indication for Use For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture. Warnings • Contents supplied STERILE using an ethylene oxide (EO) pr
Slide 46: Rhythmia Mapping System (US DFU)
Rhythmia™ Mapping System (US DFU) Indications for Use The Rhythmia Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different f
Slide 47: IntellaMap Orion Catheter (US DFU)
IntellaMap Orion™ Catheter (US DFU) Indications for Use The IntellaMap Orion High-Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. Contraindications The Rhythmia Mapping Catheter should not be used in: •
Slide 48: IntellaTip MiFi XP Temperature Ablation Catheter (US DFU)
IntellaTip MiFi™ XP Temperature Ablation Catheter (US DFU) Indications for Use The Boston Scientific Corporation (BSC) IntellaTip MiFi ™ XP Catheter is indicated for use with the BSC Maestro 3000® Controller, and Accessories for the treatment of sustained or recurrent type I atrial flutter in patien
Slide 49: Zurpaz Steerable Sheath (US DFU)
Zurpaz™ Steerable Sheath (US DFU) Indications for Use The Zurpaz Steerable Sheath is indicated for use when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. Contraindications Do not use this device: • Patients who do no
Slide 50: Diagnostic Electrode Catheter
Diagnostic Electrode Catheter Description BARD® Electrophysiology’s fixed curve diagnostic electrode catheters have an insulated polymer shaft with platinum electrodes located along the distal section of the shaft. Indications for use BARD® Electrophysiology’s fixed curve diagnostic electrode cathet
Slide 51: Steerable Diagnostic Electrode Catheter
Steerable Diagnostic Electrode Catheter Description Bard Electrophysiology Steerable Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The EP•XT™ Steerable Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. All other BARD® Ste
Slide 52: ORBITER PV Steerable Catheter
ORBITER™ PV Steerable Catheter DEVICE DESCRIPTION The BARD® ORBITER™ PV Steerable Catheter is a cardiac diagnostic catheter, which has a variable diameter loop on the distal end of a steerable shaft. The loop is controlled by the thumb-wheel mechanism on the handle, which causes the loop to expand o
Slide 53: ORBITER ST and CONFORMA Steerable Electrode Catheters
ORBITER™ ST Steerable Electrode Catheter CONFORMA™ Steerable Electrode Catheter Description The BARD® Electrophysiology ORBITER™ ST / CONFORMA™ Steerable Catheter is a radiopaque, flexible, insulated catheter with a polymer shaft and a 2 mm distal tip. The catheter handle has a slider mechanism whic
Slide 54: RADIA / RADIA XT Steerable Electrode Catheter
RADIA™/ RADIA™ XT Steerable Electrode Catheter Description The BARD® Electrophysiology RADIA™/ RADIA™ XT Steerable Catheter is a radiopaque, flexible, insulated catheter with a polymer shaft and a 2 mm distal tip. The catheter handle has a rotary mechanism which, when rotated from the neutral positi
Slide 55: DIREX Steerable Sheath
DIREX™ Steerable Sheath Intended Use/Indications for Use The DIREX™ Steerable Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices. Refer to the Instructions for Use for the complete List of Adverse Effects, Precautions, and Warning. Contraindications • K
Slide 56: BARD LABSYSTEM PRO EP Recording System
BARD® LABSYSTEM™ PRO EP Recording System INDICATIONS FOR USE The BARD® LABSYSTEM™ PRO EP Recording System is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of intracardiac electrophysi
Slide 57: Micropace Cardiac Stimulators EPS320B/BT, StimCor, StimLab
Micropace Cardiac Stimulators EPS320B/BT, StimCor™, StimLab™ Intended Use The Micropace Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electric
Slide 58: Micropace Cardiac Stimulators: General Warnings
Micropace Cardiac Stimulators EPS320B/BT, StimCor™, StimLab™ General Warnings (Continued) Warning: Stimulator must use isolated mains supply only. To avoid electrocution hazards, all parts of the Stimulator, including the computer, monitor and Stimulus Generator Unit must all be connected to the Mai
Slide 59: Micropace Cardiac Stimulators: Precautions
Micropace Cardiac Stimulators EPS320B/BT, StimCor™, StimLab™ Precautions: Caution: Precautions during use. Observe the Stimulator and patients at all times for abnormal function and rectify any problem promptly or disconnect the patient from the Stimulator (by unplugging the green plug from the gree
Slide 60: CLEARSIGN Amplifier IFU
CLEARSIGN™ Amplifier IFU Indications for Use • The LABSYSTEM™ PRO EP Recording System is intended for use as a data acquisition tool designed to facilitate the gathering, display, analysis by a physician, and storage of intracardiac electrophysiological data. • The BARD® CLEARSIGN™ Amplifier is inte
Slide 61: TSX Transseptal Needle and Stylet Set DFU
TSX™ Transseptal Needle and Stylet Set DFU Description The transseptal needle kit consists of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that
Slide 62: TSX Transseptal Needle and Stylet Set DFU
TSX™ Transseptal Needle and Stylet Set DFU Directions for Use 1. To determine the size and location of the left atrial septum, it may be helpful to perform right side angiography. 2. Thoroughly flush the transseptal needle. 3. Inspect all components prior to use for integrity and appropriateness for
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