St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update

Transcription

1 St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update

2 St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or reportstore@bioportfolio.com 2

3 St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update Summary St. Jude Medical, Inc. (SJM) is a medical device company. It develops and manufactures devices for the cardiac rhythm management, cardiovascular, cardiac surgery and atrial fibrillation therapy areas, and implantable neurostimulation devices for the management of chronic pain. Its major products includes tachycardia implantable cardioverter defibrillator (ICD) systems; atrial fibrillation (AF) products; bradycardia pacemaker systems; vascular closure products, pressure measurement guidewires, optical coherence tomography (OCT) imaging products, heart failure monitoring devices, heart valve replacement and repair products, structural heart defect devices, spinal cord stimulation and radiofrequency ablation products, ventricular assist devices and percutaneous heart pumps. The company along with its subsidiaries offers its products in the US, Europe and Asia Pacific. SJM is headquartered in St. Paul, Minnesota, the US. This report is a source for data, analysis, and actionable intelligence on the company s portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Scope: - The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments - The report analyzes all pipeline products in development for the company St. Jude Medical, Inc. - The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status) - The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date - The report provides detailed description of products in development, technical specification and functions - The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design, trial status and phase, estimated start and end date. Reasons to Buy: - Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape - Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio - To formulate effective Research & Development strategies 3

4 - Develop market-entry and market expansion strategies - Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop competition strategies by identifying the status and likely launch of the competitors pipeline products through review of the clinical trials, stage and of development, etc - Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio Additional Details Publisher : Global Data Reference : GDME722PD Number of Pages : 152 Report Format : PDF Publisher Information : 4

5 Table Of Contents for St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update Table of Contents Table of Contents 2List of Tables 7List of Figures 13St. Jude Medical, Inc. Company Snapshot 14St. Jude Medical, Inc. Company Overview 14St. Jude Medical, Inc. Pipeline Products and Clinical Trials Overview 15St. Jude Medical, Inc. Pipeline Analysis Overview 18Business Description 18Key Facts 18St. Jude Medical, Inc. - Major Products and Services 19St. Jude Medical, Inc. Pipeline Products by Development Stage 21St. Jude Medical, Inc. Clinical Trials by Trial Status 26St. Jude Medical, Inc. Pipeline Products Overview 31Accent MRI Pacemaker 31Accent MRI Pacemaker Product Overview 31Accent MRI Pacemaker Clinical Trial 32Accent ST 33Accent ST Product Overview 33All-in-one Catheter Ablation System 34All-in-one Catheter Ablation System Product Overview 34Amplatzer AAA Vascular Graft 35Amplatzer AAA Vascular Graft Product Overview 35Amplatzer Amulet Left Atrial Appendage Occluder 36Amplatzer Amulet Left Atrial Appendage Occluder Product Overview 36Amplatzer Amulet Left Atrial Appendage Occluder Clinical Trial 37AMPLATZER Cardiac Plug 38AMPLATZER Cardiac Plug Product Overview 38AMPLATZER Cardiac Plug Clinical Trial 39Amplatzer Peripheral Vascular Graft 40Amplatzer Peripheral Vascular Graft Product Overview 40AMPLATZER PFO Occluder 41AMPLATZER PFO Occluder Product Overview 41AMPLATZER PFO Occluder Clinical Trial 42AMPLATZER PFO Occluder - Cryptogenic Strokes 43AMPLATZER PFO Occluder - Cryptogenic Strokes Product Overview 43AMPLATZER PFO Occluder - Cryptogenic Strokes Clinical Trial 44Amplatzer TAA Vascular Graft 45Amplatzer TAA Vascular Graft Product Overview 45Apica VAD SIS Device 46Apica VAD SIS Device Product Overview 46Apical Access System 47Apical Access System Product Overview 47AutoMark Module 48AutoMark Module Product Overview 48Automated Anastomosis Device 49Automated Anastomosis Device Product Overview 49Axium Spinal Cord Stimulation System 50Axium Spinal Cord Stimulation System Product Overview 50Axium Spinal Cord Stimulation System Clinical Trial 51DBS Directional Lead 55DBS Directional Lead Product Overview 55EnligHTN Multi-Electrode Renal Denervation System 56EnligHTN Multi-Electrode Renal Denervation System Product Overview 56EnligHTN Multi-Electrode Renal Denervation System Clinical Trial 57EnSite AutoMap Module 59EnSite AutoMap Module Product Overview 59EnSite Precision Cardiac Mapping System 60EnSite Precision Cardiac Mapping System Product Overview 60EnSite Precision Software v2.0 61EnSite Precision Software v2.0 Product Overview 61EnSite Precision Surface Electrode Kit 62EnSite Precision Surface Electrode Kit Product Overview 62Fully Implantable Ventricular Assist System 63Fully Implantable Ventricular Assist System Product Overview 63HeartMate III LVAS - Bridge-to-Transplant 64HeartMate III LVAS - Bridge-to-Transplant Product Overview 64HeartMate III LVAS - Bridge-to-Transplant Clinical Trial 65HeartMate III LVAS - Destination Therapy 66HeartMate III LVAS - Destination Therapy Product Overview 66HeartMate III LVAS - Destination Therapy Clinical Trial 67HeartMate Percutaneous Heart Pump 68HeartMate Percutaneous Heart Pump Product Overview 68HeartMate Percutaneous Heart Pump Clinical Trial 69HeartMate X 70HeartMate X Product Overview 70HeartPOD 71HeartPOD Product Overview 71Infinity DBS System 72Infinity DBS System Product Overview 72Libra Deep Brain Stimulation System - Depression 73Libra Deep Brain Stimulation System - Depression Product Overview 73Libra Deep Brain Stimulation System - Depression Clinical Trial 74Libra Deep Brain Stimulation System - Essential Tremor 75Libra Deep Brain Stimulation System - Essential Tremor Product Overview 75Libra Deep Brain Stimulation System - Essential Tremor Clinical Trial 76Masters HP Series 15mm Mechanical Heart Valve 77Masters HP Series 15mm Mechanical Heart Valve Product Overview 77Masters HP Series 15mm Mechanical Heart Valve Clinical Trial 78MediGuide Fluoroless Navigation System 79MediGuide Fluoroless Navigation System Product Overview 79MediGuide Software MediGuide Software 17.0 Product Overview 80Nanostim Leadless Pacemaker 81Nanostim Leadless Pacemaker Product Overview 81Nanostim Leadless Pacemaker Clinical Trial 82Next Generation - Portico Valve 83Next Generation - Portico Valve Product Overview 83Next Generation Confirm 84Next Generation Confirm Product Overview 84Next Generation Device For TAVI 85Next Generation Device For TAVI Product Overview 85Next Generation Implantable DBS System - Primary Cell 86Next Generation Implantable DBS System - Primary Cell Product Overview 86Next Generation Implantable SCS System - Primary Cell 87Next Generation Implantable SCS System - Primary Cell Product Overview 87Next Generation Implantable SCS System - Rechargeable 88Next Generation Implantable SCS System - Rechargeable Product Overview 88Next Generation Trifecta Valve 89Next Generation Trifecta Valve Product Overview 89Off-pump Adjustable Annuloplasty Ring 90Off-pump Adjustable Annuloplasty Ring Product Overview 90Portico Transapical Aortic Heart Valve System - 23 mm 91Portico Transapical Aortic Heart Valve System - 23 mm Product Overview 91Portico Transapical Aortic Heart Valve System - 25 mm 92Portico Transapical Aortic Heart Valve System

6 mm Product Overview 92Portico Transapical Aortic Heart Valve System - 27 mm 93Portico Transapical Aortic Heart Valve System - 27 mm Product Overview 93Portico Transapical Aortic Heart Valve System - 29 mm 94Portico Transapical Aortic Heart Valve System - 29 mm Product Overview 94Portico Transcatheter Aortic Valve Implantation System 95Portico Transcatheter Aortic Valve Implantation System Product Overview 95Portico Transfemoral Aortic Heart Valve System - 23 mm 96Portico Transfemoral Aortic Heart Valve System - 23 mm Product Overview 96Portico Transfemoral Aortic Heart Valve System - 23 mm Clinical Trial 97Portico Transfemoral Aortic Heart Valve System - 25mm 98Portico Transfemoral Aortic Heart Valve System - 25mm Product Overview 98Portico Transfemoral Aortic Heart Valve System - 27 mm 99Portico Transfemoral Aortic Heart Valve System - 27 mm Product Overview 99Portico Transfemoral Aortic Heart Valve System - 29mm 100Portico Transfemoral Aortic Heart Valve System - 29mm Product Overview 100Proclaim DRG 101Proclaim DRG Product Overview 101Proclaim Rechargeable Model 102Proclaim Rechargeable Model Product Overview 102Proclaim Upgrade HC 103Proclaim Upgrade HC Product Overview 103Proclaim Upgrade LC 104Proclaim Upgrade LC Product Overview 104Prodigy SCS System 105Prodigy SCS System Product Overview 105Prodigy SCS System Clinical Trial 106Promote LAP System 107Promote LAP System Product Overview 107Promote Pulmonary Edema Monitor 108Promote Pulmonary Edema Monitor Product Overview 108Quadra Assura MP CRT-D 109Quadra Assura MP CRT-D Product Overview 109Quadra Assura MP CRT-D Clinical Trial 110Quartet NXT - Double Blend Lead 111Quartet NXT - Double Blend Lead Product Overview 111Quartet NXT - Large S- Curve Lead 112Quartet NXT - Large S-Curve Lead Product Overview 112Quartet NXT - Small S-Curve Lead 113Quartet NXT - Small S-Curve Lead Product Overview 113Remote Monitoring Device 114Remote Monitoring Device Product Overview 114Renova-DT Cortical Stimulation System 115Renova-DT Cortical Stimulation System Product Overview 115Repositionable Valved Stent 116Repositionable Valved Stent Product Overview 116Sensor Enabled - Advisor FL Circular Mapping Catheter 117Sensor Enabled - Advisor FL Circular Mapping Catheter Product Overview 117Sensor Enabled - EnSite Precision Module 118Sensor Enabled - EnSite Precision Module Product Overview 118Sensor Enabled - FlexAbility Ablation Catheter 119Sensor Enabled - FlexAbility Ablation Catheter Product Overview 119Sensor Enabled - Quadra Excel Guidewire 120Sensor Enabled - Quadra Excel Guidewire Product Overview 120Subclavian Delivery System 121Subclavian Delivery System Product Overview 121TactiCath Force Sensing Ablation Catheter 122TactiCath Force Sensing Ablation Catheter Product Overview 122Tendril MRI lead 123Tendril MRI lead Product Overview 123Tendril MRI lead Clinical Trial 124Third Generation EnligHTN Renal Denervation System 125Third Generation EnligHTN Renal Denervation System Product Overview 125Transapical Mitral Valve Delivery System 126Transapical Mitral Valve Delivery System Product Overview 126Transeptal Mitral Valve Delivery System 127Transeptal Mitral Valve Delivery System Product Overview 127Transfemoral Mitral Valve Delivery System 128Transfemoral Mitral Valve Delivery System Product Overview 128UltraMag Adult Ventricular Assist System 129UltraMag Adult Ventricular Assist System Product Overview 129UltraMag Pediatric Ventricular Assist System 130UltraMag Pediatric Ventricular Assist System Product Overview 130Universal Port Access System 131Universal Port Access System Product Overview 131Xpress Gen 2 132Xpress Gen 2 Product Overview 132St. Jude Medical, Inc. - Key Competitors 133St. Jude Medical, Inc. - Key Employees 134St. Jude Medical, Inc. - Key Employee Biographies 135St. Jude Medical, Inc. - Locations And Subsidiaries 136Head Office 136Other Locations & Subsidiaries 136Recent Developments 141St. Jude Medical, Inc., Recent Developments 141Mar 10, 2016: St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker 141Feb 18, 2016: FDA Panel Provides Leadership and Guidance to Companies Seeking to Advance Leadless Pacing Technology in the U.S. 142Feb 17, 2016: St. Jude Medical Receives FDA Approval for Industry s First MultiPoint Pacing Technology 142Feb 17, 2016: St. Jude Medical Announces FDA Approval Of A New Treatment Therapy For Patients Suffering From Chronic Intractable Pain 143Feb 17, 2016: St. Jude Medical Receives FDA Approval for Industry s First MultiPoint Pacing Technology 144Feb 08, 2016: St. Jude Medical Announces Launch of OPTIS Mobile System in Europe and Japan 145Jan 27, 2016: St. Jude Medical Reports Fourth Quarter and Full-Year 2015 Results 146Jan 22, 2016: FDA Classifies St. Jude Medical Field Action for 447 of the Company's Optisure High Voltage Leads as a Class 1 Advisory in the U.S. 148Jan 13, 2016: St. Jude Medical Announces Preliminary Fourth Quarter 2015 Financial Results 149Dec 11, 2015: New Data Demonstrates Burst Stimulation from St. Jude Medical Provides Superior Pain Relief over Traditional Tonic Spinal Cord Stimulation for the Treatment of Chronic Pain 150Appendix 152Methodology 152About GlobalData 152Contact Us 152Disclaimer 152 6

7 List Of Tables in St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update List of Tables St. Jude Medical, Inc. Pipeline Products and Clinical Trials Overview 15 St. Jude Medical, Inc. Pipeline Products by Equipment Type 15 St. Jude Medical, Inc. Pipeline Products by Indication 17 St. Jude Medical, Inc. Clinical Trials by Trial Status 17 St. Jude Medical, Inc., Key Facts 18 St. Jude Medical, Inc., Major Products and Services 19 St. Jude Medical, Inc. Number of Pipeline Products by Development Stage 21 St. Jude Medical, Inc. Pipeline Products Summary by Development Stage 22 St. Jude Medical, Inc. Clinical Trials by Trial Status 26 St. Jude Medical, Inc. Clinical Trials Summary 27 Accent MRI Pacemaker - Product Status 31 Accent MRI Pacemaker - Product Description 31 Accent MRI Pacemaker - Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging Lead Investigational Device Exemption Study 32 Accent MRI Pacemaker - Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II 32 Accent ST - Product Status 33 Accent ST - Product Description 33 All-in-one Catheter Ablation System - Product Status 34 All-in-one Catheter Ablation System - Product Description 34 Amplatzer AAA Vascular Graft - Product Status 35 Amplatzer AAA Vascular Graft - Product Description 35 Amplatzer Amulet Left Atrial Appendage Occluder - Product Status 36 Amplatzer Amulet Left Atrial Appendage Occluder - Product Description 36 Amplatzer Amulet Left Atrial Appendage Occluder - Amplatzer Amulet Observational Post-market Study 37 AMPLATZER Cardiac Plug - Product Status 38 AMPLATZER Cardiac Plug - Product Description 38 AMPLATZER Cardiac Plug - Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients with Atrial Fibrillation Undergoing Drug-eluting Stent Implantation Due to Complex Coronary Artery Disease 39 7

8 Amplatzer Peripheral Vascular Graft - Product Status 40 Amplatzer Peripheral Vascular Graft - Product Description 40 AMPLATZER PFO Occluder - Product Status 41 AMPLATZER PFO Occluder - Product Description 41 AMPLATZER PFO Occluder - Emergency/Compassionate Use PFO Occluder 42 AMPLATZER PFO Occluder - Cryptogenic Strokes - Product Status 43 AMPLATZER PFO Occluder - Cryptogenic Strokes - Product Description 43 AMPLATZER PFO Occluder - Cryptogenic Strokes - Device Closure Versus Medical Therapy for Secondary Prevention in Cryptogenic Stroke Patients with High-risk Patent Foramen Ovale (DEFENSE-PFO) 44 AMPLATZER PFO Occluder - Cryptogenic Strokes - Patent Foramen Ovale Closure with the AMPLATZER PFO OCCLUDER in Patients with Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy 44 Amplatzer TAA Vascular Graft - Product Status 45 Amplatzer TAA Vascular Graft - Product Description 45 Apica VAD SIS Device - Product Status 46 Apica VAD SIS Device - Product Description 46 Apical Access System - Product Status 47 Apical Access System - Product Description 47 AutoMark Module - Product Status 48 AutoMark Module - Product Description 48 Automated Anastomosis Device - Product Status 49 Automated Anastomosis Device - Product Description 49 Axium Spinal Cord Stimulation System - Product Status 50 Axium Spinal Cord Stimulation System - Product Description 50 Axium Spinal Cord Stimulation System - A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain 51 Axium Spinal Cord Stimulation System - A Post Market Cohort with the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy 51 Axium Spinal Cord Stimulation System - A Post Market Observational Cohort Study to Assess the Performance of the Spinal Modulation Dorsal Root Ganglion Stimulator System for the Management of Chronic Post Surgical Pain 51 Axium Spinal Cord Stimulation System - A Post Market Observational Study on the Effect of DRG Stimulation in Patients with Chronic Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome): SYMPATHY 52 Axium Spinal Cord Stimulation System - A Post Market Observational Study on the Effect of DRG Stimulation in Patients with Chronic Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome): SYMPATHY 8

9 52 Axium Spinal Cord Stimulation System - A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain 52 Axium Spinal Cord Stimulation System - A Prospective Post Market Trial of DRG stiimulation with the Commercially Available Axium 53 Axium Spinal Cord Stimulation System - A Prospective, Randomized, Multi-center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation AXIUM Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial) 53 Axium Spinal Cord Stimulation System - A Randomized Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium Neurostimulator Therapy as a Treatment for Persistent Inguinal Pain Following Surgical Intervention 53 Axium Spinal Cord Stimulation System - A Randomized Pilot Study to Assess Differences in the Subjects' Experience of Stimulation-induced Paraesthesia Between Two Different Spinal Cord Stimulation Devices: The Axium Dorsal Root Ganglion Stimulation System versus the Prime Advanced Dorsal Column Stimulation System (CHARACTER SCS) 54 Axium Spinal Cord Stimulation System - Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy 54 DBS Directional Lead - Product Status 55 DBS Directional Lead - Product Description 55 EnligHTN Multi-Electrode Renal Denervation System - Product Status 56 EnligHTN Multi-Electrode Renal Denervation System - Product Description 56 EnligHTN Multi-Electrode Renal Denervation System - A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence 57 EnligHTN Multi-Electrode Renal Denervation System - Evaluation Six Months of Renal Denervation System in Patients with Heart Failure 57 EnligHTN Multi-Electrode Renal Denervation System - International Non-randomized, Single-arm, Long-term Follow-Up Study Of Patients with Uncontrolled Hypertension 57 EnligHTN Multi-Electrode Renal Denervation System - Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension (EnligHTN IV) 58 EnligHTN Multi-Electrode Renal Denervation System - Renal Sympathetic Denervation for Treatment of Metabolic Syndrome Associated Hypertension (Metabolic Syndrome Study) 58 EnSite AutoMap Module - Product Status 59 EnSite AutoMap Module - Product Description 59 EnSite Precision Cardiac Mapping System - Product Status 60 EnSite Precision Cardiac Mapping System - Product Description 60 EnSite Precision Software v2.0 - Product Status 61 EnSite Precision Software v2.0 - Product Description 61 EnSite Precision Surface Electrode Kit - Product Status 62 9

10 EnSite Precision Surface Electrode Kit - Product Description 62 Fully Implantable Ventricular Assist System - Product Status 63 Fully Implantable Ventricular Assist System - Product Description 63 HeartMate III LVAS - Bridge-to-Transplant - Product Status 64 HeartMate III LVAS - Bridge-to-Transplant - Product Description 64 HeartMate III LVAS - Bridge-to-Transplant - Evaluating the HeartMate 3 in a Post-market Approval Setting: The HeartMate 3 Registry (ELEVATE) 65 HeartMate III LVAS - Bridge-to-Transplant - Thoratec Corporation HeartMate 3 Less Invasive Surgery (LIS) Study 65 HeartMate III LVAS - Bridge-to-Transplant - Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3 IDE Clinical Study Protocol 65 HeartMate III LVAS - Destination Therapy - Product Status 66 HeartMate III LVAS - Destination Therapy - Product Description 66 HeartMate III LVAS - Destination Therapy - Driveline Silicone Skin Interface (SSI) Registry 67 HeartMate III LVAS - Destination Therapy - Thoratec Corporation Heartmate III CE Mark Clinical Investigation Plan 67 HeartMate Percutaneous Heart Pump - Product Status 68 HeartMate Percutaneous Heart Pump - Product Description 68 HeartMate Percutaneous Heart Pump - Coronary Interventions in High-risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II) 69 HeartMate Percutaneous Heart Pump - Thoratec Corporation HeartMate PHP Cardiogenic Shock Trial 69 HeartMate X - Product Status 70 HeartMate X - Product Description 70 HeartPOD - Product Status 71 HeartPOD - Product Description 71 Infinity DBS System - Product Status 72 Infinity DBS System - Product Description 72 Libra Deep Brain Stimulation System - Depression - Product Status 73 Libra Deep Brain Stimulation System - Depression - Product Description 73 Libra Deep Brain Stimulation System - Depression - A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression 74 Libra Deep Brain Stimulation System - Depression - Deep Brain Stimulation for Treatment-Resistant Depression 74 Libra Deep Brain Stimulation System - Essential Tremor - Product Status 75 10

11 Libra Deep Brain Stimulation System - Essential Tremor - Product Description 75 Libra Deep Brain Stimulation System - Essential Tremor - A Clinical Evaluation of the Advanced Neuromodulation System (ANS) Totally Implantable Deep Brain Stimulation System for the Suppression of Tremor in the Upper Extremities of Patients with Essential Tremor 76 Masters HP Series 15mm Mechanical Heart Valve - Product Status 77 Masters HP Series 15mm Mechanical Heart Valve - Product Description 77 Masters HP Series 15mm Mechanical Heart Valve - A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM Master Series 15mm Rotatable Mechanical Heart Valve (HALO Clinical Study) 78 MediGuide Fluoroless Navigation System - Product Status 79 MediGuide Fluoroless Navigation System - Product Description 79 MediGuide Software Product Status 80 MediGuide Software Product Description 80 Nanostim Leadless Pacemaker - Product Status 81 Nanostim Leadless Pacemaker - Product Description 81 Nanostim Leadless Pacemaker - Nanostim Study for a Leadless Cardiac Pacemaker System 82 Nanostim Leadless Pacemaker - Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker 82 Next Generation - Portico Valve - Product Status 83 Next Generation - Portico Valve - Product Description 83 Next Generation Confirm - Product Status 84 Next Generation Confirm - Product Description 84 Next Generation Device For TAVI - Product Status 85 Next Generation Device For TAVI - Product Description 85 Next Generation Implantable DBS System - Primary Cell - Product Status 86 Next Generation Implantable DBS System - Primary Cell - Product Description 86 Next Generation Implantable SCS System - Primary Cell - Product Status 87 Next Generation Implantable SCS System - Primary Cell - Product Description 87 Next Generation Implantable SCS System - Rechargeable - Product Status 88 Next Generation Implantable SCS System - Rechargeable - Product Description 88 Next Generation Trifecta Valve - Product Status 89 Next Generation Trifecta Valve - Product Description 89 Off-pump Adjustable Annuloplasty Ring - Product Status 90 Off-pump Adjustable Annuloplasty Ring - Product Description 90 11

12 Portico Transapical Aortic Heart Valve System - 23 mm - Product Status 91 Portico Transapical Aortic Heart Valve System - 23 mm - Product Description 91 Portico Transapical Aortic Heart Valve System - 25 mm - Product Status 92 Portico Transapical Aortic Heart Valve System - 25 mm - Product Description 92 Portico Transapical Aortic Heart Valve System - 27 mm - Product Status 93 Portico Transapical Aortic Heart Valve System - 27 mm - Product Description 93 Portico Transapical Aortic Heart Valve System - 29 mm - Product Status 94 Portico Transapical Aortic Heart Valve System - 29 mm - Product Description 94 Portico Transcatheter Aortic Valve Implantation System - Product Status 95 Portico Transcatheter Aortic Valve Implantation System - Product Description 95 Portico Transfemoral Aortic Heart Valve System - 23 mm - Product Status 96 Portico Transfemoral Aortic Heart Valve System - 23 mm - Product Description 96 Portico Transfemoral Aortic Heart Valve System - 23 mm - Assessment of the St. Jude Medical Portico Transcatheter Aortic Valve Implant (TAVI) and the SJM TAVI Transfemoral Delivery System (Portico TF EU) 97 Portico Transfemoral Aortic Heart Valve System - 23 mm - International International Long-term Follow-up Study Of Patients Implanted with A Portico Valve 97 Portico Transfemoral Aortic Heart Valve System - 23 mm - Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial 97 Portico Transfemoral Aortic Heart Valve System - 25mm - Product Status 98 Portico Transfemoral Aortic Heart Valve System - 25mm - Product Description 98 Portico Transfemoral Aortic Heart Valve System - 27 mm - Product Status 99 Portico Transfemoral Aortic Heart Valve System - 27 mm - Product Description 99 Portico Transfemoral Aortic Heart Valve System - 29mm - Product Status 100 Portico Transfemoral Aortic Heart Valve System - 29mm - Product Description 100 Proclaim DRG - Product Status 101 Proclaim DRG - Product Description 101 Proclaim Rechargeable Model - Product Status 102 Proclaim Rechargeable Model - Product Description 102 Proclaim Upgrade HC - Product Status 103 Proclaim Upgrade HC - Product Description 103 Proclaim Upgrade LC - Product Status 104 Proclaim Upgrade LC - Product Description

13 Prodigy SCS System - Product Status 105 Prodigy SCS System - Product Description 105 Prodigy SCS System - A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs 106 Prodigy SCS System - Success Using Neuromodulation with BURST (SUNBURST) Study 106 Promote LAP System - Product Status 107 Promote LAP System - Product Description 107 Promote Pulmonary Edema Monitor - Product Status 108 Promote Pulmonary Edema Monitor - Product Description 108 Quadra Assura MP CRT-D - Product Status 109 Quadra Assura MP CRT-D - Product Description 109 Quadra Assura MP CRT-D - Italian Registry on Multipoint Left Ventricular 110 Quadra Assura MP CRT-D - MultiPoint Pacing Clinical Study To Build upon Quadripolar Pacing System with the Quadra Assura MP Cardiac Resynchronization Therapy defibrillator (CRT-D) and Quartet Lead to Assess Pacing in the Heart 110 Quartet NXT - Double Blend Lead - Product Status 111 Quartet NXT - Double Blend Lead - Product Description 111 Quartet NXT - Large S-Curve Lead - Product Status 112 Quartet NXT - Large S-Curve Lead - Product Description 112 Quartet NXT - Small S-Curve Lead - Product Status 113 Quartet NXT - Small S-Curve Lead - Product Description 113 Remote Monitoring Device - Product Status 114 Remote Monitoring Device - Product Description 114 Renova-DT Cortical Stimulation System - Product Status 115 Renova-DT Cortical Stimulation System - Product Description 115 Repositionable Valved Stent - Product Status 116 Repositionable Valved Stent - Product Description 116 Sensor Enabled - Advisor FL Circular Mapping Catheter - Product Status 117 Sensor Enabled - Advisor FL Circular Mapping Catheter - Product Description 117 Sensor Enabled - EnSite Precision Module - Product Status 118 Sensor Enabled - EnSite Precision Module - Product Description 118 Sensor Enabled - FlexAbility Ablation Catheter - Product Status

14 Sensor Enabled - FlexAbility Ablation Catheter - Product Description 119 Sensor Enabled - Quadra Excel Guidewire - Product Status 120 Sensor Enabled - Quadra Excel Guidewire - Product Description 120 Subclavian Delivery System - Product Status 121 Subclavian Delivery System - Product Description 121 TactiCath Force Sensing Ablation Catheter - Product Status 122 TactiCath Force Sensing Ablation Catheter - Product Description 122 Tendril MRI lead - Product Status 123 Tendril MRI lead - Product Description 123 Tendril MRI lead - A Clinical Evaluation of the SJM MRI Conditional Pacing System in Subjects Undergoing Cardiac Magnetic Resonance Imaging in India 124 Tendril MRI lead - Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging Lead Investigational Device Exemption Study 124 Third Generation EnligHTN Renal Denervation System - Product Status 125 Third Generation EnligHTN Renal Denervation System - Product Description 125 Transapical Mitral Valve Delivery System - Product Status 126 Transapical Mitral Valve Delivery System - Product Description 126 Transeptal Mitral Valve Delivery System - Product Status 127 Transeptal Mitral Valve Delivery System - Product Description 127 Transfemoral Mitral Valve Delivery System - Product Status 128 Transfemoral Mitral Valve Delivery System - Product Description 128 UltraMag Adult Ventricular Assist System - Product Status 129 UltraMag Adult Ventricular Assist System - Product Description 129 UltraMag Pediatric Ventricular Assist System - Product Status 130 UltraMag Pediatric Ventricular Assist System - Product Description 130 Universal Port Access System - Product Status 131 Universal Port Access System - Product Description 131 Xpress Gen 2 - Product Status 132 Xpress Gen 2 - Product Description 132 St. Jude Medical, Inc., Key Employees 134 St. Jude Medical, Inc., Key Employee Biographies 135 St. Jude Medical, Inc., Other Locations

15 St. Jude Medical, Inc., Subsidiaries

16 List Of Figures, Charts and Diagrams in St. Jude Medical, Inc. (STJ) - Product Pipeline Analysis, 2016 Update List of Figures St. Jude Medical, Inc. Pipeline Products by Equipment Type 16 St. Jude Medical, Inc. Pipeline Products by Development Stage 21 St. Jude Medical, Inc. Clinical Trials by Trial Status 26 16

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