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U.S. Opportunities in Surgical Coronary Revascularization
May 2003, 497 pages
Report #HRI-051-1-US-0503

Coronary artery bypass graft (CABG) surgery has been the ultimate weapon in
the treatment of severe coronary artery disease for the past three decades.
Although percutaneous transluminal coronary angioplasty (PTCA) has captured
a dominant share of the patient caseload based on its less invasive profile,
problems with restenosis—even with stenting—have limited its use for more
complex cases. Thus, CABG surgery has remained the treatment of choice for
patients with diffuse disease, long lesions and multiple-vessel disease based
on its proven long-term outcomes and cost effectiveness.

This situation is expected to change dramatically with the launch of
drug-eluting stents in 2003, which will virtually eliminate the problem of
restenosis for many patients. Although new product performance is generally
optimized in clinical studies through careful patient selection and the use of
Tier I clinicians, the stent outcomes have shown true efficacy across a
broad group of patients, including many with complex disease or complicating
factors, such as diabetes. These outcomes will enable relatively rapid
penetration of the “low end” CABG surgery caseload and will even support
a challenge for more complex cases.

Even prior to this new challenge, surgeons and companies involved in CABG 
surgery were developing techniques and products intended to reduce the 
invasiveness of CABG surgery, and the ability to balance invasiveness, 
effectiveness and costs will play an important role in sustaining cardiac
surgery caseloads. Most of these efforts have focused on eliminating CPB and
its potential to produce long-term neurological deficits through a shift to
“beating heart” surgery. Unfortunately, the space and visualization limitations
of beating heart surgery require a major adjustment in technique, and most
surgeons have been unwilling to compromise outcomes for the sake of
reducing the procedure’s invasiveness. As a result, the use of beating heart
surgery has not exceeded 20% to 25% of the caseload for the past
few years.

The advent of automated anastomosis devices, intended to quickly, easily
and consistently create reliable anastomoses, may solve the space and
visualization problems of beating heart surgery by facilitating the most
difficult and time-consuming portion of the procedure. Other approaches are
advocating continued use of CPB but using a smaller circuit or specialized
devices to limit damage to the blood and brain. The use of surgical sealants
to ensure the quality of the anastomotic seal and the use of robotic systems
to facilitate surgery in a limited space are also expected to promote a shift
to minimally invasive cardiac surgery.

This report presents a detailed, thoughtful analysis of this critical watershed
period in coronary artery disease management and forecasts the future of
CABG surgery and the associated product markets as they face renewed
competition from the new drug-eluting stents. Product sales are forecast to
increase from less than $700 million in 2002 to $900 million in 2008 as new
opportunities offset declining demand for traditional products. Specific issues
addressed include:

  • The impact of drug-eluting stents on the CABG surgery caseload,
    including procedure and market forecasts through 2008;

  • Obstacles to broader adoption of minimally invasive CABG surgery
    techniques and developments intended to remove these obstacles,
    including their impact on the trend in beating heart versus stopped
    heart CABG surgery and associated product markets through 2008;

  • The appropriate and emerging role of endoscopic CABG techniques;

  • Technical and reimbursement challenges to broader adoption of
    minimally invasive vein harvesting techniques and the procedure and
    market trends through 2008;

  • The use of centrifugal pumps versus heart lung machines in CPB;

  • Prospects for several unique technologies intended to reduce the
    trauma of CPB, allowing surgeons to use the familiar, preferred
    technique;

  • Detailed information on nearly 20 automated anastomosis devices
    and their promise for replacing hand suturing techniques and revitalizing
    interest in minimally invasive CABG surgery;

  • Detailed information on more than 10 stabilizers and positioners
    intended to facilitate beating heart surgery and their impact on its
    acceptance;

  • The current and emerging role of intrasurgical cardiac assist in
    beating heart procedures;

  • The role of robotic assistance and advanced visualization systems in
    facilitating the trend to minimally invasive cardiac surgery and the
    likely adoption of these technologies;

  • The opportunities for surgical sealants to improve the quality of
    anastomoses and even facilitate the trend to less invasive techniques,
    including automated anastomosis devices; and

  • The portfolio significance of cardiac surgery products to companies
    supplying this market and potential acquisition and divestiture
    opportunities.

In addition, this report details a full variety of products and devices currently
used in the performance of CABG surgery or under development, including
information on development background, features and benefits, clinical
experience, clinical status and pricing. Each product market is econometrically
modeled using leading indicators and penetration rates, with unit and dollar
forecasts provided for 2001 through 2008. Market share data are provided
for 2002, accompanied by discussions of trends in competitive positions
and posturing.

Methodology

This report, distributed exclusively by Medtech Insight, has been produced by Health Research International's in-house analysts who use an extensive library of proprietary data to build the market model and discuss trends within the context of clinical indications and competing technologies. This information is then meticulously confirmed, refined, and expanded through interviews with key clinicians, researchers, market competitors, and industry insiders to complete the forward-looking analysis and provide a truly objective assessment of market evolution and success.

 

TABLE OF CONTENTS

 

EXECUTIVE SUMMARY

Procedure Trends

Total Revascularization Products Market

Traditional Cardiopulmonary Bypass Products

Mini Bypass and Intracardiac Pumps

Anastomosis Devices

Beating Heart Surgery Disposables

Vein Harvesting Products

Other Emerging Technologies

Cardiac Surgical Sealants

Transmyocardial Revascularization

Product Suppliers

 

1.0 OVERVIEW OF CARDIOVASCULAR DISORDERS

1.1 Components and Function

1.1.1 Heart

1.1.2 Cardiac Cycle

1.1.3 Blood Vessels

1.2 Disorders of Heart and Circulation

1.2.1 Hypertension

1.2.2 Coronary Artery Disease

1.2.3 Congestive Heart Failure

1.2.4 Cardiac Arrhythmias

1.2.5 Stroke

1.2.6 Rheumatic Heart Disease

1.2.7 Acquired Valve Disorders

1.2.8 Congenital Heart Defects

1.3 Cardiovascular Disease Diagnosis

1.3.1 Non-Imaging Techniques

1.3.2 Imaging Techniques

1.3.2.1 Radiographic Imaging

1.3.2.2 Echocardiography

1.3.2.3 Radionuclide Scanning

1.3.2.4 Magnetic Resonance Imaging

1.3.2.5 Coronary Angiography

1.3.2.6 Intravascular Ultrasound

1.3.2.7 Intracoronary Angioscopy

1.3.3 Emerging Diagnostic Modalities

1.3.3.1 In Vitro Cardiac Markers

1.3.3.2 Predictor Tests

1.3.3.3 Monoclonal Antibody-Based Imaging of Thrombosis

1.4 Treatment of Cardiovascular Disease

1.4.1 Medical Management

1.4.1.1 Traditional Medical Management

1.4.1.2 Lipid-Lowering Drugs

1.4.2 Surgical Intervention

1.4.2.1 Coronary Artery Bypass Surgery

1.4.2.2 Valve Surgery and Treatment of Congenital Heart Defects

1.4.2.3 Transmyocardial Revascularization

1.4.2.4 Surgical Management of Atrial Fibrillation

1.4.3 Transcatheter Therapies

1.4.3.1 Percutaneous Transluminal Coronary Angioplasty

1.4.3.2 Coronary Stenting

1.4.3.3 Laser Angioplasty

1.4.3.4 Atherectomy

1.4.3.5 Transcatheter Thrombectomy and Thrombolysis

1.4.3.6 Transcatheter Defect and Valve Repair

1.4.3.7 Percutaneous Transmyocardial Revascularization

1.4.3.8 Catheter Ablation of Arrhythmias

 

2.0 CONVENTIONAL (STOPPED HEART) OPEN HEART SURGERY

2.1 Cardiopulmonary Bypass

2.1.1 Extracorporeal Circuit

2.1.2 Complications

2.1.3 Products

2.1.3.1 Blood Pumps

2.1.3.1.1 Roller Pumps

2.1.3.1.2 Centrifugal Pumps

2.1.3.2 Oxygenators

2.1.3.2.1 Design and Function

2.1.3.2.2 Add On Features

2.1.3.2.3 New Materials

2.1.3.2.4 Products and Suppliers

2.1.3.3 Accessories

2.1.3.3.1 Blood Filters

2.1.3.3.2 Hemoconcentrators

2.1.3.3.3 Cannulae and Tubing

2.1.3.4 Product Trends (12 companies profiled)

2.2 Blood Recovery and Salvage

2.2.1 Cardiotomy Suction

2.2.2 Blood Salvage

2.2.2.1 Autotransfusion Process

2.2.2.2 Products and Technology

2.3 Myocardial Protection

2.3.1 Cardioplegia Circuit

2.3.2 Access for Cardioplegia

2.3.3 Cold versus Warm Cardioplegia

2.3.4 Products and Technology

2.4 Procedure Forecasts

2.4.1 Coronary Artery Bypass Graft Surgery

2.4.2 Valve Procedures

2.4.3 Other Procedures

2.5 Product Markets and Supplier Shares

2.5.1 Traditional Products

2.5.1.1 Blood Pumps

2.5.1.2 Traditional Bypass Disposables

2.5.1.3 Supplier Shares

2.5.2 Emerging Bypass Disposables

2 5.2.1 Anastomosis Devices

2.5.2.2 Anastomosis Assist Devices

2.5.2.3 Embolic Protection Devices

2.5.2.4 Mini Bypass Systems

 

3.0 MINIMALLY INVASIVE (BEATING HEART) CARDIAC SURGERY

3.1 Beating Heart Techniques

3.2 Products

3.2.1 Stabilization and Positioning Products (13 companies profiled)

3.2.2 Anastomosis Devices

3.2.2.1 Design Criteria

3.2.2.2 Products (18 companies profiled)

3.2.3 Anastomosis Assist Devices (2 companies profiled)

3.2.4 Intrasurgical Cardiac Assist (4 companies profiled)

3.2.5 Minimally Invasive Vein Harvesting

3.2.5.1 Graft Sources

3.2.5.1.1 Radial Artery Grafts

3.2.5.1.2 Gastroepiploic Artery Grafts

3.2.5.1.3 Internal Thoracic Artery Grafts

3.2.5.2 Minimally Invasive Harvesting Techniques

3.2.5.2.1 Harvesting Technique

3.2.5.2.2 Advantages and Limitations

3.2.5.2.3 Endoscopic versus Direction Vision Approaches

3.2.5.2.4 Products (4 companies profiled)

3.2.6 Intraluminal Shunts

3.2.6.1 Design

3.2.6.2 Application

3.2.6.3 Advantages and Limitations

3.2.6.4 Clinical Experience

3.2.6.5 Products and Suppliers

3.3 Trend in Beating Heart Procedures

3.4 Markets Analysis

3.4.1 Cardiac Stabilizers, Positioners and Accessories

3.4.2 Anastomosis Devices

3.4.3 Anastomosis Assist Devices

3.4.4 Intracardiac Assist

3.4.5 Vein Harvesting Systems

 

4.0 ADJUNCTIVE TECHNOLOGIES

4.1 Endoscopic CABG

4.1.1 Products and Suppliers (2 companies profiled)

4.1.2 Clinical Challenges and Benefits

4.1.3 Product Requirements

4.1.4 Market Analysis

4.2 Cardiac Robotics

4.2.1 Background

4.2.2 Technology

4.2.2.1 Automated Mechanical Assist Devices

4.2.2.2 Telemanipulators

4.2.2.3 Autonomous Robots

4.2.3 Applications in Cardiac Surgery

4.2.4 Regulatory Issues

4.2.5 Reimbursement versus Benefits

4.2.6 Products (6 companies profiled)

4.2.7 Procedure Trend

4.2.8 Market Analysis

4.3 Advanced Visualization Systems

4.3.1 Technology

4.3.2 Requirements for Success

4.3.3 Products and Suppliers (9 companies profiled)

4.3.4 Market Analysis

 

5.0 SURGICAL SEALANTS

5.1 Surgical Sealant Design Criteria

5.2 Types of Surgical Sealants

5.3 Fibrin Sealants

5.3.1 Mechanism of Action

5.3.2 Development History

5.3.3 Commercial vs. Non-Commercial Products

5.3.4 Autologous Platelet Gels (5 companies profiled)

5.3.5 Allogenic Products

5.3.6 Viral Screening and Inactivation of Blood Products

5.3.6.1 New Risks

5.3.6.2 Viral Inactivation and Removal Methods

5.3.7 Commercial Fibrin Sealants/Surgical Hemostasis Products (7 companies profiled)

5.4 Recombinant Surgical Hemostasis Products

5.4.1 Cell Culture Technology

5.4.2 Transgenic Technology (2 companies profiled)

5.5 Alternatives to Hemostatic Sealants (8 companies profiled)

5.6 Market Analysis

 

6.0 TRANSMYOCARDIAL REVASCULARIZATION

6.1 Clinical Background

6.2 TMR Technique

6.3 Clinical Results

6.3.1 Long-Term Results

6.3.2 Adjunctive Use with CABG

6.3.3 Patient Selection

6.4 Proposed Mechanisms of Action

6.4.1 Channel-Mediated Perfusion

6.4.2 Angiogenesis

6.4.3 Myocardial Denervation

6.4.4 Placebo Effect

6.5 Products and Suppliers (8 companies profiled)

6.6 Market Analysis

6.6.1 Procedure Forecast

6.6.2 Market Forecast

6.6.3 Competitive Analysis

 

7.0 COMPANY PROFILES

7.1 A-Med Systems, Inc.

7.2 Baxter International, Inc.

7.3 CardioVention, Inc.

7.4 Chase Medical, Inc.

7.5 Coalescent Surgical, Inc.

7.6 Cohesion Technologies, Inc.

7.7 Computer Motion, Inc.

7.8 CryoLife, Inc.

7.9 Edwards Lifesciences Corporation

7.10 Estech, Inc.

7.11 Fusion Medical Technologies, Inc.

7.12 Guidant Corporation

7.13 Haemacure Corporation

7.14 Intuitive Surgical, Inc.

7.15 Johnson & Johnson

7.16 Jostra AG (Jostra Bentley Corporation)

7.17 Medtronic, Inc.

7.18 Pall Corporation

7.19 SNIA Group SpA/Sorin Biomedica Group

7.20 St. Jude Medical, Inc.

7.21 Terumo Corporation (Terumo Cardiovascular Systems)

7.22 Ventrica, Inc.

7.23 Vista Medical Technologies, Inc.

 

APPENDIX: COMPANY LIST

 

This report includes 147 exhibits.  For a detailed listing, please call (949) 219-0150 or e-mail sales@medtechinsight.com.

 

Copyright 2003, Health Research International


Ordering Information

Title

Report# Publication
Date
List Price

U.S. Opportunities in Surgical Coronary Revascularization

HRI-051-1
-US-0503

May
2003

$4,995*

 


*The pdf version of each report costs an additional $500 when purchased in addition to the hardcopy.

 

To order reports or obtain information about special pre-publication offers from within the U.S., contact sales@medtechinsight.com. From outside the U.S., contact internationalsales@medtechinsight.com. You can also call 1.949.219.0150 (or toll-free within the U.S. at 1.888.290.2225) or fax 1.949.219.0067.

 

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