The future holds strong growth for the overall cardiovascular surgery products market, however, as new technologies evolve, significant shifts in market share for several product segments are also expected. Cardiovascular surgery techniques, among the most invasive and costly therapeutic options available, are seeing increased competition from less-invasive transcatheter and endovascular alternatives.

Included in this report from Medtech Insight is an overview of cardiovascular disease management, as well as comprehensive analyses of products and technologies used in open-heart surgery and minimally-invasive cardiac surgery. Also covered are applications and market analyses of cardiac assist replacement technologies, prosthetic heart valves, prosthetic vascular grafts, and vascular and cardiac repair patches and fabrics. An essential tool for executives working in or looking to enter into the market, the report is filled with 24 profiles of leading device makers, 123 illuminating exhibits and hundreds of pages of expert analysis and insight.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

     i. Trends in Cardiac Surgery

     ii. Cardiac Surgery Products

     iii. Cardiac Assist Products

     iv. Valve Replacement and Repair Products

     v. Prosthetic Grafts, Patches, and Wall Repair Biomaterials

     vi. Competitive Analysis

1. OVERVIEW OF CARDIOVASCULAR DISEASE MANAGEMENT

     1.1 Cardiovascular Diseases

          1.1.1 Hypertension

          1.1.2 Coronary Artery Disease

          1.1.3 Congestive Heart Failure

          1.1.4 Arrhythmia

          1.1.5 Stroke

          1.1.6 Rheumatic Heart Disease

          1.1.7 Acquired Valve Disorders

          1.1.8 Congenital Heart Defects

     1.2 Cardiovascular Disease Diagnosis

          1.2.1 Non-Imaging Techniques

          1.2.2 Imaging Techniques

                  1.2.2.1 Noninvasive Imaging

                             1.2.2.1.1 Radiographic Imaging

                             1.2.2.1.2 Echocardiography

                             1.2.2.1.3 Radionuclide Scanning

                             1.2.2.1.4 Magnetic Resonance Imaging

                  1.2.2.2 Invasive Imaging Techniques

                             1.2.2.2.1 Coronary Angiography

                             1.2.2.2.2 Intravascular Ultrasound

                             1.2.2.2.3 Intracoronary Angioscopy

          1.2.3 Emerging Diagnostic Techniques

                  1.2.3.1 In Vitro Cardiac Markers

                  1.2.3.2 Predictor Tests

                  1.2.3.3 Monoclonal Antibody-Based Imaging of Thrombosis

     1.3 Therapeutic Management of Cardiovascular Disease

          1.3.1 Medical Management

                  1.3.1.1 Traditional Medical Management

                  1.3.1.2 Lipid-Lowering Drugs

          1.3.2 Surgical Intervention

                  1.3.2.1 Coronary Artery Bypass Surgery

                  1.3.2.2 Valve Surgery and Treatment of Congenital Heart
                             Defects

                  1.3.2.3 Transmyocardial Revascularization

          1.3.3 Transcatheter Therapies

                  1.3.3.1 Percutaneous Transluminal Coronary Angioplasty

                  1.3.3.2 Coronary Stenting

                  1.3.3.3 Laser Angioplasty

                  1.3.3.4 Atherectomy

                  1.3.3.5 Transcatheter Thrombolectomy and Thrombolysis

                  1.3.3.6 Transcatheter Defect Repair

                  1.3.3.7 Percutaneous Transmyocardial Revascularization

                  1.3.3.8 Catheter Ablation of Arrhythmias

2. OPEN-HEART SURGERY

     2.1 Product-Oriented Tasks

          2.1.1 The Extracorporeal Circuit

          2.1.2 Cardiotomy Suction

          2.1.3 Myocardial Protection

          2.1.4 Blood Salvage

     2.2 Sites and Procedures

     2.3 Products and Markets

          2.3.1 Blood Pumps

                  2.3.1.1 Roller Pumps

                  2.3.1.2 Centrifugal Pumps

          2.3.2 Oxygenators

                  2.3.2.1 Bubbler and Membrane Models

                  2.3.2.2 Product Trends

                             2.3.2.2.1 Heat Exchangers

                             2.3.2.2.2 Venous Reservoirs

                             2.3.2.2.3 Anti-Thrombogenic Coatings

                  2.3.2.3 Products and Suppliers

                  2.3.2.4 Market Analysis

          2.3.3 Cardiotomy Reservoirs

                  2.3.3.1 Products and Suppliers

                  2.3.3.2 Market Analysis

          2.3.4 Arterial Filters

                  2.3.4.1 Products and Technology

                  2.3.4.2 Market Analysis

          2.3.5 Custom Tubing Packs

                  2.3.5.1 Competitive Trends

                  2.3.5.2 Market Analysis

          2.3.6 Cardioplegia Systems and Administration Kits

                  2.3.6.1 Cardioplegia Techniques

                  2.3.6.2 Retrograde Cardioplegia

                  2.3.6.3 Warm Cardioplegia

                  2.3.6.4 Products and Technology

                             2.3.6.4.1 Cardioplegia Management Systems

                             2.3.6.4.2 Administration Kits

                  2.3.6.5 Market Analysis

          2.3.7 Cannulae

                  2.3.7.1 Venous Cannulation

                  2.3.7.2 Arterial Cannulation

                  2.3.7.3 Cardioplegia Cannulation

                  2.3.7.4 Products and Technology

                  2.3.7.5 Market Analysis

          2.3.8 Hemoconcentrators

                  2.3.8.1 Products and Technology

                  2.3.8.2 Market Analysis

          2.3.9 Autotransfusion Systems

                  2.3.9.1 Products and Technology

                  2.3.9.2 Market Analysis

          2.3.10 Monitoring

                   2.3.10.1 Blood Gas Content and Electrolytes

                               2.3.10.1.1 Techniques and Products

                               2.3.10.1.2 Suppliers

                   2.3.10.2 Blood Coagulation Monitoring

                   2.3.10.3 Myocardial Monitoring

     2.4 Opportunities in Conventional Open-Heart Surgery Products

          2.4.1 Anti-Coagulation

                  2.4.1.1 Coatings and Surface Treatments

                  2.4.1.2 Heparin Removal Systems

          2.4.2 Product Modifications for Female Patients

     2.5 Transmyocardial Revascularization

          2.5.1 Technique

          2.5.2 Products

          2.5.3 Potential Competition

          2.5.4 Clinical Results and Efficacy

          2.5.5 Transmyocardial Revascularization and Angiogenesis

          2.5.6 Reimbursement

          2.5.7 Procedure Forecasts

          2.5.8 Market Analysis

3. MINIMALLY INVASIVE CARDIAC SURGERY

     3.1 Techniques and Products

          3.1.1 Approaches

                  3.1.1.1 “On-Pump” (Arrested Heart) Approach

                  3.1.1.2 “Off-Pump” (Beating Heart) Approach

                  3.1.1.3 Assisted (Stabilized Beating Heart) Approach

          3.1.2 Minimally Invasive Cardiac Surgery Products

          3.1.3 Conversion to Minimally Invasive Cardiac Surgery
                  Techniques

          3.1.4 Market Analysis

     3.2 Minimally Invasive Saphenous Vein Harvesting

          3.2.1 Technique

          3.2.2 Outcomes

          3.2.3 Products

          3.2.4 Product Markets

4. CARDIAC ASSIST AND HEART REPLACEMENT TECHNOLOGIES

     4.1 Cardiac Assist Applications

     4.2 Intra-Aortic Balloon Pumps

          4.2.1 Clinical Applications

          4.2.2 Technique and Complications

          4.2.3 Product Trends

          4.2.4 Modifications of Standard Intra-Aortic Balloon Pumps

                  4.2.4.1 Ascending Aorta Balloon Pump

                  4.2.4.2 Intra-Ventricular Balloon Pumps

                  4.2.4.3 Intra-Aortic Axial Flow Pumps

          4.2.5 Intra-Aortic Balloon Pumps Products

          4.2.6 Market Analysis

     4.3 Ventricular Assist Systems

          4.3.1 Applications

          4.3.2 Complications

          4.3.3 Types of Ventricular Assist Devices

                  4.3.3.1 External Models

                  4.3.3.2 Implantable Ventricular Assist Devices

                  4.3.3.3 Other Ventricular Assist Projects

          4.3.4 Market Analysis

     4.4 Permanent Cardiac Support and Heart Replacement

          4.4.1 Design Specifications for Permanent Cardiac Assist

          4.4.2 Permanent Cardiac Assist and Replacement Heart Programs

          4.4.3 Market Analysis

     4.5 Surgical Alternatives to Cardiac Assist Devices for Heart Failure

          4.5.1 Dynamic Cardiomyoplasty

          4.5.2 Partial Ventriculectomy

          4.5.3 Endoventricular Circular Patch Plasty

5. PROSTHETIC HEART VALVES

     5.1 Design Specifications

     5.2 Mechanical Heart Valves

          5.2.1 Advantages and Disadvantages

          5.2.2 Types

                  5.2.2.1 Tilting Disc Valves

                  5.2.2.2 Bileaflet Valves

     5.3 Tissue Heart Valves

          5.3.1 Advantages and Disadvantages

          5.3.2 Sources and Configurations

                  5.3.2.1 Source Material

                  5.3.2.2 Stented versus Stentless

          5.3.3 Types

                  5.3.3.1 Stented Porcine Bioprostheses

                  5.3.3.2 Stentless Porcine Bioprostheses

                  5.3.3.3 Pericardial Bioprostheses

     5.4 Allograft Valves

          5.4.1 Preservation Techniques

                  5.4.1.1 Cryopreservation

                  5.4.1.2 Fresh Transplantation

          5.4.2 Suppliers

     5.5 Autograft Valves

     5.6 Annuloplasty Rings

     5.7 Valve Conduits

     5.8 Procedure and Product Trends

          5.8.1 Procedures and Techniques

                  5.8.1.1 Procedure Trends

                  5.8.1.2 Minimally Invasive Cardiac Surgery

                  5.8.1.3 Mitral Valve Repair in Congestive Heart Failure

          5.8.2 Product Trends

                  5.8.2.1 Impact of Upgrades on Mechanical and Tissue
                             Valve Competition

                  5.8.2.2 Alternatives to Valves

     5.9 Market Analyses

          5.9.1 Mechanical Valves

          5.9.2 Tissue Valves

          5.9.3 Allograft Valves

          5.9.4 Annuloplasty Rings

6. PROSTHETIC VASCULAR GRAFTS

     6.1 Clinical Applications

          6.1.1 Vascular Occlusive Disease

          6.1.2 Aneurysms

          6.1.3 Acute Renal Failure

     6.2 Diameter Applications

          6.2.1 Large-Diameter Grafts

          6.2.2 Medium-Diameter Grafts

          6.2.3 Small-Diameter Grafts

     6.3 Graft Materials

          6.3.1 Polyester Grafts

          6.3.2 Polytetrafluoroethylene Grafts

          6.3.3 Biologic Grafts

                  6.3.3.1 Human Umbilical Vein

                  6.3.3.2 Bovine

                  6.3.3.3 Human Saphenous Vein

          6.3.4 New and Emerging Grafts

     6.4 Endovascular Stent-Grafts

          6.4.1 Design Specifications

          6.4.2 Types and Configurations

          6.4.3 Limitations of Abdominal Aortic Aneurysm Stent-Graft
                  Systems

          6.4.4 Products

     6.5 Market Analysis

          6.5.1 Standard Vascular Grafts

                  6.5.1.1 Polyester Grafts

                  6.5.1.2 Polytetrafluoroethylene Grafts

                  6.5.1.3 Biological Grafts

          6.5.2 Endovascular Stent-Grafts

          6.5.3 Competitor Market Shares

7. VASCULAR AND CARDIAC REPAIR PATCHES AND FABRICS

     7.1 Applications

          7.1.1 Reconstruction

          7.1.2 Suture Buttressing

          7.1.3 Management of Reoperation in Presence of Adhesions

     7.2 Product Materials and Configurations

          7.2.1 Polytetrafluoroethylene

          7.2.2 Polyester Fabrics

          7.2.3 Bovine Pericardium

     7.3 Complications

     7.4 Market Analysis

     7.5 Competitor Market Shares

8. COMPANY PROFILES

     8.1   3M Healthcare Cardiovascular Systems Division

     8.2   ABIOMED, Inc.

     8.3   Arrow International, Inc.

     8.4   C.R. Bard, Inc.

     8.5   Baxter International, Inc.

     8.6   Boston Scientific Corporation

     8.7   CardioThoracic Systems, Inc.

     8.8   CryoLife, Inc.

     8.9   Datascope Corporation

     8.10 Eclipse Surgical Technologies, Inc.

     8.11 Genzyme Corporation

     8.12 Gish Biomedical, Inc.

     8.13 W.L. Gore & Associates, Inc.

     8.14 Guidant Corporation

     8.15 Haemonetics Corporation

     8.16 Heartport, Inc.

     8.17 Medtronic, Inc.

     8.18 Minntech Corporation

     8.19 Pall Corporation

     8.20 PLC Systems, Inc.

     8.21 Sorin Biomedical, Inc.

     8.22 St. Jude Medical, Inc.

     8.23 Thermo Cardiosystems, Inc.

     8.24 Thoratec Laboratories Corporation

COMPANY LISTING

LIST OF EXHIBITS

Exhibit ES-1:  Cardiovascular Surgery Products, Market Forecast, 1997-2003 

Exhibit ES-2:  Open-Heart Surgery, Procedure Volumes Forecast, 1997-2003 

Exhibit ES-3:  Cardiac Surgery Products, Market Forecast, 1997-2003 

Exhibit ES-4:  Cardiac Assist Products, Market Forecast, 1997-2003 

Exhibit ES-5:  Prosthetic Heart Valves and Repair Products, Market Forecast, 1997-2003 

Exhibit ES-6:  Prosthetic Grafts, Stent-Grafts, Patches and Wall Repair Biomaterials, Market Forecast, 1997-2003 

Exhibit ES-7:  1998, Cardiovascular Surgery Products Market, Share by Supplier 

Exhibit 1-1:    1996, Selected Data on Cardiovascular Disease and Other Conditions 

Exhibit 1-2:    Major Cardiovascular Diseases 

Exhibit 1-3:    Comparison of Left- and Right-Sided Heart Failure 

Exhibit 1-4:    Selected Types of Arrhythmia 

Exhibit 1-5:    Principal Congenital Heart Defects 

Exhibit 1-6:    Modalities for Diagnosing Cardiovascular Disease 

Exhibit 1-7:    Principal Drugs Used in the Treatment of Cardiovascular Disease 

Exhibit 1-8:    Types of Surgical Intervention for Cardiovascular Disease 

Exhibit 1-9:    Transcatheter Interventions for Cardiovascular Disease 

Exhibit 1-10:  Indications for Percutaneous Transluminal Coronary Angioplasty 

Exhibit 1-11:  Comparison of Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Bypass Graft Surgery 

Exhibit 2-1:    Product-Oriented Tasks Associated with Open-Heart Surgery 

Exhibit 2-2:    Potential Complications of Cardiopulmonary Bypass 

Exhibit 2-3:    Open-Heart Surgery, Procedure Volumes Forecast, 1997-2003 

Exhibit 2-4:    Roller Pumps, Market Forecast, 1997-2003 

Exhibit 2-5:    Selected Currently Available and Developmental Centrifugal Pumps 

Exhibit 2-6:    Centrifugal Blood Pumps, Market Forecast, 1997-2003 

Exhibit 2-7:    1998, Centrifugal Pumps Market, Share by Supplier 

Exhibit 2-8:    Comparison of Soft-Shell and Hard-Shell Venous Reservoirs 

Exhibit 2-9:    Selected Membrane Oxygenators 

Exhibit 2-10:  Oxygenators, Market Forecast, 1997-2003 

Exhibit 2-11:  1998, Membrane Oxygenators Market, Share by Supplier 

Exhibit 2-12:  Selected Cardiotomy and Venous Reservoirs 

Exhibit 2-13:  Cardiotomy Reservoirs, Market Forecast, 1997-2003 

Exhibit 2-14:  1998, Cardiotomy Reservoirs Market, Share by Supplier 

Exhibit 2-15:  Types of Filters Used in an Extracorporeal Circuit 

Exhibit 2-16:  Selected Arterial Filters 

Exhibit 2-17:  Arterial Filters, Market Forecast, 1997-2003 

Exhibit 2-18:  1998, Arterial Filters Market, Share by Supplier 

Exhibit 2-19:  Typical Components of Table and Pump Tubing Packs 

Exhibit 2-20:  Custom Tubing Packs, Market Forecast, 1997-2003 

Exhibit 2-21:  1998, Custom Tubing Packs Market, Share by Supplier 

Exhibit 2-22:  Cardioplegia Administration Sets, Market Forecast, 1997-2003 

Exhibit 2-23:  1998, Cardioplegia Administration Sets Market, Share by Supplier 

Exhibit 2-24:  Bypass Cannulae, Market Forecast, 1997-2003 

Exhibit 2-25:  1998, Bypass Cannulae Market, Share by Supplier 

Exhibit 2-26:  Hemoconcentrators, Market Forecasts, 1997-2003 

Exhibit 2-27:  1998, Hemoconcentrators Market, Share by Supplier 

Exhibit 2-28:  Selected Autotransfusion Systems 

Exhibit 2-29:  Autotransfusion Disposables, Market Forecast, 1997-2003 

Exhibit 2-30:  1998, Autotransfusion Disposables Market, Share by Supplier 

Exhibit 2-31:  Specialized Blood Monitoring Performed During Open-Heart Surgery 

Exhibit 2-32:  Selected Online Cardiopulmonary Bypass Blood Gas Analysis Systems 

Exhibit 2-33:  Indications, Approaches, and Findings of Transmyocardial Revascularization 

Exhibit 2-34:  Comparison of Selected Transmyocardial Revascularization Laser Systems 

Exhibit 2-35:  Standard Angina Classifications 

Exhibit 2-36:  Transmyocardial Revascularization, Procedure Volumes Forecast, 1997-2003 

Exhibit 2-37:  Transmyocardial Revascularization Products, Market Forecast, 1997-2003 

Exhibit 3-1:    Major Drawbacks and Side Effects of Traditional Open-Heart Surgery 

Exhibit 3-2:    Comparison of Cardiac Surgery Approaches 

Exhibit 3-3:    Selected Results of CTS MIDCAB Registry 

Exhibit 3-4:    Selected Currently Available and Developmental Minimally Invasive Cardiac Surgery Products 

Exhibit 3-5:    Conversion of Coronary Artery Bypass Graft and Valve Caseloads to Minimally Invasive Techniques, 1997-2003 

Exhibit 3-6:    Minimally Invasive Cardiac Surgery Products, Market Forecast, 1997-2003 

Exhibit 3-7:    1998, Minimally Invasive Cardiac Surgery Products Market, Share by Supplier 

Exhibit 3-8:    Clinical Comparison of Endoscopic versus Traditional Saphenous Vein Harvesting 

Exhibit 3-9:    Selected Minimally Invasive Saphenous Vein Harvesting Systems 

Exhibit 3-10:  Minimally Invasive Saphenous Vein Harvesting Systems, Market Forecast, 1997-2003 

Exhibit 3-11:  1998, Minimally Invasive Saphenous Vein Harvesting Systems Market, Share by Supplier 

Exhibit 4-1:    Applications for Mechanical Cardiac Assist Devices

Exhibit 4-2:    Primary Indications for Intra-Aortic Balloon Pump Therapy

Exhibit 4-3:    Intra-Aortic Balloon Pump Controllers, Market Forecast, 1997-2003 

Exhibit 4-4:    Intra-Aortic Balloon Pump Disposables, Market Forecast, 1997-2003 

Exhibit 4-5:    Intra-Aortic Balloon Pump Systems, Market Forecast, 1997-2003 

Exhibit 4-6:    1998, Intra-Aortic Balloon Pump Systems Market, Share by Supplier 

Exhibit 4-7:    Comparison of External and Implantable Ventricular Assist Devices 

Exhibit 4-8:    Selected External and Implantable Ventricular Assist Devices 

Exhibit 4-9:    Ventricular Assist Devices, Market Forecast, 1997-2003 

Exhibit 4-10:  1998, Ventricular Assist Device Market, Share by Supplier 

Exhibit 4-11:  Design Specifications for Permanent Cardiac Assist Devices 

Exhibit 4-12:  Selected Permanent Cardiac Assist Devices and Artificial Hearts Under Development 

Exhibit 4-13:  Permanent Cardiac Assist Devices and Replacement Hearts, Market Forecast, 1997-2003 

Exhibit 5-1:    Overview of Native Heart Valves 

Exhibit 5-2:    Characteristics of Ideal Prosthetic Heart Valve 

Exhibit 5-3:    Comparison of Mechanical, Tissue, and Allograft Heart Valves 

Exhibit 5-4:    Selected Mechanical Heart Valves 

Exhibit 5-5:    Tissue Valve Comparison by Source and Configuration 

Exhibit 5-6:    Selected Stented Tissue Valves 

Exhibit 5-7:    Selected Stentless Tissue Valves 

Exhibit 5-8:    Annuloplasty Ring Design Characteristics 

Exhibit 5-9:    Selected Annuloplasty Rings 

Exhibit 5-10:  Selected Data on Valve Replacements and Repairs, 1995-1997 

Exhibit 5-11:  Valve Replacement and Repair Procedure Volumes Forecast, 1997-2003 

Exhibit 5-12:  Initial Clinical Results with Port-Access Valve Surgery 

Exhibit 5-13:  Valve Surgery Re-Operations, by Procedure Type, 1995-1997 

Exhibit 5-14:  Prosthetic Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-15:  Mechanical Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-16:  1998, Mechanical Heart Valves, Share by Supplier 

Exhibit 5-17:  Xenograft Tissue Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-18:  Stented Xenograft Tissue Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-19:  Stentless Xenograft Tissue Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-20:  1998, Xenograft Tissue Heart Valves Market, Share by Supplier 

Exhibit 5-21:  Allograft Heart Valves, Market Forecast, 1997-2003 

Exhibit 5-22:  1998, Allograft Heart Valves Market, Share by Supplier 

Exhibit 5-23:  Annuloplasty Rings and Accessories, Market Forecast, 1997-2003 

Exhibit 5-24:  1998, Annuloplasty Rings and Accessories, Share by Supplier 

Exhibit 6-1:    Major Indications for Prosthetic Grafts 

Exhibit 6-2:    Surgical Interventions for Peripheral Vascular Occlusive Disease 

Exhibit 6-3:    Major Aneurysms of the Coronary and Peripheral Vasculature 

Exhibit 6-4:    Applications for Prosthetic Vascular Grafts, by Diameter 

Exhibit 6-5:    Desirable Performance Characteristics of Prosthetic Grafts 

Exhibit 6-6:    Selected New and Emerging Vascular Graft Materials and Approaches 

Exhibit 6-7:    Design Specifications for Endovascular Stent-Graft Repair Systems 

Exhibit 6-8:    Current Stent-Graft Types and Configurations 

Exhibit 6-9:    Selected Developmental Endovascular Abdominal Aortic Aneurysm Stent-Graft Systems 

Exhibit 6-10:  Vascular Grafts, Market Forecast, 1997-2003 

Exhibit 6-11:  Vascular Grafts by Material and Diameter, Market Forecast, 1997-2003 

Exhibit 6-12:  Polyester Vascular Grafts, Market Forecast, 1997-2003 

Exhibit 6-13:  Polytetrafluoroethylene Vascular Grafts, Market Forecast, 1997-2003 

Exhibit 6-14:  Biological Vascular Grafts, Market Forecast, 1997-2003 

Exhibit 6-15:  Endovascular Stent-Grafts, Market Forecast, 1997-2003 

Exhibit 6-16:  1998, Vascular Grafts Market, Share by Supplier 

Exhibit 7-1:    Cardiac Patches and Wall Repair Biomaterials Applications 

Exhibit 7-2:    1998, Cardiac Patches and Fabrics Market, by Material 

Exhibit 7-3:    Cardiac Patches and Fabrics, Market Forecast, 1997-2003 

Exhibit 7-4:    1998, Cardiac Patches and Fabrics Market, Share by Supplier   

Copyright 1999, Medtech Insight, LLC