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U.S. OPPORTUNITIES IN SURGICAL HEART VALVE TECHNOLOGIES


320 Pages | 105 Exhibits | 2009 Analysis | Forecasts Through 2015

  • Publisher: Health Research International
  • Distributor: LSI

 


Transcatheter heart valve technologies are positioned to become the next disruptive influence in cardiovascular medicine over the coming decade and are expected to drive a multi-billion dollar market. However, questions remain about:
  • The timing of adoption based on clinical trial designs and outcomes to date;
  • The numbers and types of patients these technologies will ultimately benefit and how reimbursement will impact those caseloads;
  • The timing and degree to which the transcatheter technologies will cannibalize the existing surgical caseload and prosthetic heart valves market; and
  • Which of the numerous emerging transcatheter and surgical technologies will have the greatest impact on the market, especially the overall balance of procedures and market growth.

For any company participating in or investigating the substantial opportunity presented by the changing U.S. heart valve market, Health Research International's two new reports-one detailing surgical therapies and the other detailing transcatheter therapies-are a must-have addition to your business intelligence. The combined reports use over 200 exhibits to help present:

  • Detailed evidence-based epidemiological analyses, including valve therapy candidate pools by valve position, disease type and severity, and patient characteristics;
  • Detailed analyses of clinical trials of new transcatheter valve technologies and minimally invasive surgical technologies and their expected impact on product adoption and indications;
  • Econometrically modeled forecasts of valve procedures by position, type and approach through 2015;
  • Econometrically modeled forecasts of product markets by type, including relevant pricing and supplier shares; and
  • Detailed profiles of more than 80 new technologies, both primary and adjunctive, as well as the companies developing them.

This important new report on "U.S. Opportunities in Surgical Heart Valve Technologies" contains 105 tables, exhibits and graphics detailing patient volumes, procedure volumes, product market models and forecasts, supplier market shares, and key product and clinical data. Leading suppliers and innovative companies and technologies are profiled.

For details on the tandem Heart Valve Report visit U.S. OPPORTUNITIES IN TRANSCATHETER HEART VALVE TECHNOLOGIES.


EXECUTIVE SUMMARY
Overview 
Patients
Procedures
Products
Markets
Competitors

1.0 OVERVIEW OF HEART VALVE DISEASE 
1.1 Valve Types and Function 
1.2 Role of Valves in Cardiac Cycle 
1.3 Etiology of Heart Valve Disease 
	1.3.1 Rheumatic Heart Disease 
	1.3.2 Degenerative Valve Disorders 
	1.3.3 Functional Valve Disorders 
	1.3.4 Congenital Valve Disorders 
		1.3.4.1 Complex Congenital Defects 
		1.3.4.2 Bicuspid Aortic Valve Disease 
	1.3.5 Bacterial Endocarditis
1.4 Diagnosis of Heart Valve Disease 
	1.4.1 Auscultation 
	1.4.2 Electrocardiography 
	1.4.3 Chest X-rays 
	1.4.4 Echocardiography 
	1.4.5 Coronary Angiography 
	1.4.6 Other Diagnostic Methods 
1.5 Treatment of Heart Valve Disease 
	1.5.1 Medical Management 
	1.5.2 Surgical Intervention 
	1.5.3 Transcatheter Valve Repair and Replacement 
1.6 Mortality 
1.7 Epidemiology of Valve Disease 
1.8 Valve Disease by Position 
	1.8.1 Aortic Valve Disease 
		1.8.1.1 Aortic Stenosis 
			1.8.1.1.1  Severity Grading 
			1.8.1.1.2  Prevalence 
			1.8.1.1.3  Diagnosed Severe Aortic Stenosis 
		1.8.1.2 Aortic Valve Regurgitation 
			1.8.1.2.1 Prevalence 
			1.8.1.2.2 Treatment 
	1.8.2 Acquired Mitral Valve Disease 
		1.8.2.1 Mitral Valve Stenosis 
		1.8.2.2 Mitral Valve Prolapse 
		1.8.2.3 Mitral Valve Regurgitation 
			1.8.2.3.1 Etiologies 
			1.8.2.3.2 Severity Grading 
			1.8.2.3.3 Prevalence 
			1.8.2.3.4 Treatment 
	1.8.3 Tricuspid Valve Disease 
	1.8.4 Pulmonary Valve Disease 
1.9 Guidelines for Management of Valvular Disease 
	1.9.1 Aortic Valve Disease 
		1.9.1.1 Stenosis 
		1.9.1.2 Regurgitation 
	1.9.2 Mitral Valve Disease 
		1.9.2.1 Mitral Stenosis 
		1.9.2.2 Mitral Regurgitation 
	1.9.3 Acute Infective Endocarditis 

Exhibit 1-1: The Four Heart Valves 
Exhibit 1-2: Etiology of Valvular Disease 
Exhibit 1-3: Selected Congenital Heart Defects 
Exhibit 1-4: Major Techniques Used to Diagnose Heart Valve Disease 
Exhibit 1-5: Selected Diagnostic Approaches to Valvular Disease 
Exhibit 1-6: Treatment Options for Heart Valve Disease 
Exhibit 1-7: Use of Drug Therapy in Treatment of Valvular Disease 
Exhibit 1-8: Trends in Valve Surgery by Anatomy, 2000-2008 
Exhibit 1-9: Mitral and Aortic Surgery Survival Rates 
Exhibit 1-10: Overview of Major Epidemiological Studies of Heart Valve Disease 
Exhibit 1-11: Selected Findings of Euro Heart Survey on Valvular Heart Disease 
Exhibit 1-12: Overview of Aortic Valve Diseases 
Exhibit 1-13: Grading of Severity of Aortic Stenosis 
Exhibit 1-14: Reported Prevalence of Moderate to Severe Aortic Stenosis 
Exhibit 1-15: Severe Aortic Stenosis, Patient Forecast, 2008-2015 
Exhibit 1-16: Reported Prevalence of Moderate to Severe Aortic Regurgitation 
Exhibit 1-17: Moderate-Severe Aortic Regurgitation, Patient Forecast, 2008-2015 
Exhibit 1-18: Comparison of Major Mitral Valve Diseases 
Exhibit 1-19: Mitral Regurgitation Etiologies 
Exhibit 1-20: Grading of Severity of Mitral Regurgitation 
Exhibit 1-21: Reported Prevalence of Moderate to Severe Mitral Regurgitation 
Exhibit 1-22: Moderate-Severe Mitral Regurgitation, Patient Forecast, 2008-2015 
Exhibit 1-23: Overview of Tricuspid and Pulmonary Valve Diseases 
Exhibit 1-24: ACC/AHA Guidelines for Management of Aortic Valve Disease 
Exhibit 1-25: ACC/AHA Guidelines for Surgical Management of Non-Ischemic Mitral Regurgitation

2.0 SURGICAL VALVE REPLACEMENT

2.1 Replacement Procedure 
	2.1.1 Traditional Median Sternotomy Approach 
	2.1.2 Minimally Invasive Approaches 
		2.1.2.1 Approaches 
		2.1.2.2 Advantages 
		2.1.2.3 Limitations 
	2.1.3 Enabling/Facilitating Technologies for MI Valve Surgery 
		2.1.3.1 Robotic Surgery 
		2.1.3.2 Adjunctive Cardiac Surgery Technologies 
	2.1.4 Conclusions Regarding MI Valve Surgery 
2.2 Valve Prostheses 
	2.2.1 Mechanical Valves 
		2.2.1.1 Designs 
		2.2.1.2 Materials 
		2.2.1.3 Advantages 
		2.2.1.4 Limitations 
	2.2.2 Xenograft Tissue Valves 
		2.2.2.1 Tissue Sources 
		2.2.2.2 Stented versus Stentless 
		2.2.2.3 Advantages 
		2.2.2.4 Limitations 
	2.2.3 Allograft Valves 
2.3 Traditional Prosthetic Heart Valve Products 
	2.3.1 Mechanical Heart Valves 
	2.3.2 Tissue Heart Valves 
	2.3.3 Allograft Valves 
		2.3.3.1 Cryopreservation 
		2.3.3.2 Sterilization and Decellularization 
		2.3.3.3 Suppliers 
2.4 Emerging Prostheses and Approaches 
	2.4.1 Autologous Tissue Valves 
	2.4.2 New Tissue Valve Designs 
	2.4.3 Synthetic Heart Valves 
	2.4.4 Tissue-Engineered Valves 
		2.4.4.1 Process and Components 
		2.4.4.2 Programs 
		2.4.5.3 Challenges  to Commercial Realization 
		2.4.4.4 Prospects 
	2.4.5 Valve Suturing and Implantation Technologies 
	2.4.6 Aortic Valve Bypass 
	2.4.7 Transapical Delivery of Percutaneous Valve Technologies 
	2.4.8 Valve Resection Devices 
2.5 Surgical Valve Replacements 
	2.5.1 Procedures by Position 
	2.5.2 Procedures by Type 
	2.5.3 Standalone versus Concomitant Procedures 
2.6 Market Analysis 
	2.6.1 Mechanical Valves 
	2.6.2 Xenograft Tissue Valves 

Exhibit 2-1: Comparison of Surgical Approaches for Valve Replacement 
Exhibit 2-2: Advantages of Minimally Invasive Valve Replacement 
Exhibit 2-3: Drawbacks of Minimally Invasive Valve Replacement 
Exhibit 2-4: Selected Enabling Technologies for MI Valve Surgery, 2009 
Exhibit 2-5: Selected Robotic Technologies with Application to Valve Surgery, 2009 
Exhibit 2-6: Selected Adjunctive Cardiac Surgical Technologies with Application for Heart Valve Surgery, 2009 
Exhibit 2-7: Design Criteria for Ideal Prosthetic Heart Valve 
Exhibit 2-8: Comparison of Mechanical, Tissue and Allograft Heart Valves 
Exhibit 2-9: Mechanical Valve Designs 
Exhibit 2-10: Prosthetic Tissue Valve Materials and Configurations 
Exhibit 2-11: Selected Mechanical Heart Valves, 2009 
Exhibit 2-12: Selected Xenograft Tissue Valves, 2009 
Exhibit 2-13: Selected Emerging Surgical Valve Technologies, 2009 
Exhibit 2-14: Selected Valve Technologies Facilitating MI Implantation, 2009 
Exhibit 2-15: Arbor Surgical Technologies' Trilogy Modular Pericardial Valve 
Exhibit 2-16: Comparison of Explanted Trilogy and Perimount Valves 
Exhibit 2-17: ATS Medical 3F Therapeutic Heart Valves 
Exhibit 2-18: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar 
Exhibit 2-19: Sorin Perceval S Sutureless Aortic Valve 
Exhibit 2-20: ValveXchange VXi Technology 
Exhibit 2-21: Selected Synthetic Valve Technologies, 2009 
Exhibit 2-22: Tissue Engineering Process 
Exhibit 2-23: Selected Heart Valve Tissue Engineering Programs, 2009 
Exhibit 2-24: Challenges to Commercialization of Tissue Engineering Products 
Exhibit 2-25: Selected Valve Suturing and Advanced Implantation Technologies, 2009 
Exhibit 2-26: Cinch Advanced Implantation System versus Standard Holder 
Exhibit 2-27: Teleflex Medical Valve Suturing Technologies 
Exhibit 2-28: Cardious' AvA Aortic Valve Bypass Graft System 
Exhibit 2-29: Correx LV Connector and Applicator 
Exhibit 2-30: Transapical Delivery of Percutaneous Heart Valve 
Exhibit 2-31: Selected Transapical Valve Technologies, 2009 
Exhibit 2-32: Overview of Valve Resection Development Programs, 2009 
Exhibit 2-33: Quaden & Lutter Endoscopic Valve Resection Prototype 
Exhibit 2-34: W. German Heart Center Essen, Rotational Valve Resection Prototype 
Exhibit 2-35: Surgical Valve Procedures by Position and Type, 2008-2015 
Exhibit 2-36: Surgical Replacement Valves, 2008-2015 
Exhibit 2-37: Prosthetic Heart Valves, Market Forecast, 2008-2015 
Exhibit 2-38: Mechanical Heart Valves, Market Forecast, 2008-2015 
Exhibit 2-39: Mechanical Heart Valves, Supplier Shares, 2008 
Exhibit 2-40: Xenograft Heart Valves, Market Forecast, 2008-2015 
Exhibit 2-41: Xenograft Heart Valves, Supplier Shares, 2008 
 
3.0 SURGICAL VALVE REPAIR

3.1 Techniques 
3.2 Operative Approaches 
	3.2.1 Traditional Open Heart Surgery 
	3.2.2 Direct Vision Minimal Access Heart Valve Repair 
	3.2.3 Video-Assisted Endoscopic Valve Repair 
	3.2.4 Robotically-Assisted Mitral Valve Repair 
	3.2.5 Beating Heart Valve Repair 
	3.2.6 Aortic Valve Sparing Surgery 
	3.2.7 Transapical 
3.3 Valve Repair Technologies 
	3.3.1 Annuloplasty Rings 
		3.3.1.1 Designs 
		3.3.1.2 Products 
	3.3.2 Artificial Chordae 
	3.3.3 Emerging Technologies and Approaches 
3.4 Procedure Forecast by Position 
3.5 Market Analysis 
	3.5.1 Annuloplasty Rings 
	3.5.2 Other Repair Products 

Exhibit 3-1: Heart Valve Surgical Repair Techniques 
Exhibit 3-2: Current and Emerging Surgical Approaches for Valve Repair 
Exhibit 3-3: Design Characteristics of Annuloplasty Rings 
Exhibit 3-4: Selected Annuloplasty Rings, 2009 
Exhibit 3-5: Gore-Tex Artificial Chordae 
Exhibit 3-6: Selected Emerging Valve Repair Technologies, 2009 
Exhibit 3-7: Babic Chordal Replacement Technique and Devices 
Exhibit 3-8: Kalangos-Bioring 
Exhibit 3-9: CoroNeo Extra-Aortic Ring 
Exhibit 3-10  CUBE srl Fully Flexible Annuloplasty Ring 
Exhibit 3-11: Myocor Coapsys System 
Exhibit 3-12: Mardil BACE Device 
Exhibit 3-13: MiCardia Dynamic Annuloplasty Platform 
Exhibit 3-14: NeoChord Technology and Approach 
Exhibit 3-15: TransCardiac Therapeutics' MitraFlex System 
Exhibit 3-16: Surgical Valve Repair by Position, Procedure Forecast, 2008-2015 
Exhibit 3-17: Annuloplasty Rings and Accessories, Market Forecast, 2008-2015 
Exhibit 3-18: Annuloplasty Rings and Accessories, Supplier Shares, 2008 
Exhibit 3-19: Other Repair Products, Market Forecast, 2008-2015 


4.0 SPECIALTY VALVE PRODUCTS
4.1 Clinical Applications 
	4.1.1 Rastelli Procedure 
	4.1.2 Ross Procedure 
		4.1.2.1 Approaches 
		4.1.2.2 Advantages and Limitations 
		4.1.2.3 Clinical Experience 
		4.1.2.4 Homograft Alternatives 
		4.1.2.5 International Ross Registry 
	4.1.3 Ross II Procedure 
	4.1.4 Thoracic Aortic Aneurysm with Valve Involvement 
	4.1.5 Aortic Endocarditis 
	4.1.6 Bentall Procedure 
4.2 Products and Suppliers 
4.3 Emerging Products 
4.4 Procedure Forecast 
4.5 Market Analysis 

Exhibit 4-1: Major Applications for Specialty Valve Products 
Exhibit 4-2: Normal Heart and Rastelli Repaired Heart 
Exhibit 4-3: Overview of Ross Procedure 
Exhibit 4-4: Characteristics of Ross Procedure 
Exhibit 4-5: Characteristics of Ross Procedure Patients, 1986-2004 
Exhibit 4-6: Major Aortic Components and Selected Aneurysms 
Exhibit 4-7: Button Bentall Procedure 
Exhibit 4-8: Selected Specialty Valve Products, 2005 
Exhibit 4-9: Comparative Literature of Homograft vs Contegra Pulmonary Valved Conduit 
Exhibit 4-10: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar 
Exhibit 4-11: Custom TPV Implant for Transapical Delivery 
Exhibit 4-12: Custom Valved Stent for Transventricular Pulmonary Implantation 
Exhibit 4-13: Specialty Valve Procedures, Forecast, 2008-2015 
Exhibit 4-14: Specialty Valve Products, Market Forecast, 2008-2015 
Exhibit 4-15: Specialty Valve Products, Supplier Shares, 2008 

5.0 COMPANY PROFILES

5.1 AorTech International plc 
5.2 ATS Medical, Inc. 
5.3 Arbor Surgical Technologies, Inc.
5.4 CryoLife, Inc. 
5.5 Edwards Lifesciences Corporation 
5.6 Medtronic, Inc. 
5.7 On-X Life Technologies 
5.8 St. Jude Medical, Inc. 
5.9 Sorin Group

Company listing available upon request.

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This report is listed in the following markets:
Cardiovascular and Vascular