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U.S. OPPORTUNITIES IN TRANSCATHETER HEART VALVE TECHNOLOGIES


250 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 Transcatheter 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 SURGICAL 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 TRANSCATHETER AORTIC VALVE IMPLANTATION

2.1 Patient Selection 
2.2 Delivery Approaches 
2.3 Clinical Experience 
2.4 Products and Suppliers 
2.5 Transcatheter Valve Resection 
2.6 Procedure Forecast 
2.7 Market Analysis 

Exhibit 2-1: Overview of Transcatheter Aortic Valve Implantation Approaches 
Exhibit 2-2: Overview of TAVI Clinical Experience 
Exhibit 2-3: Overview of Transcatheter Aortic Valve Designs 
Exhibit 2-4: Transcatheter Aortic Valve Implantation Programs, 2009 
Exhibit 2-5: Advanced Bio Prosthetic Surfaces' PercValve System 
Exhibit 2-6: The ATS 3f Entrata Aortic Valve System: 
Exhibit 2-7: The Coremove Repositionable Valved Stent 
Exhibit 2-8: Direct Flow Medical's Aortic Valve Prosthesis 
Exhibit 2-9: Edwards Lifesciences' Sapien Valve 
Exhibit 2-10: Transapical Delivery of the Sapien Valve 
Exhibit 2-11: Endoluminal Technology Research Valve 
Exhibit 2-12: The AorTx Self-Expanding Valve 
Exhibit 2-13: Heart Leaflet Technologies' TAVR System 
Exhibit 2-14: Components of the JenaValve Aortic Valve Replacement System 
Exhibit 5-15: Medtronic's CoreValve System 
Exhibit 2-16: Medtronic's Embracer Aortic Valve Bioprosthesis 
Exhibit 2-17: Sadra Medical's Lotus Valve System 
Exhibit 2-18: St. Jude Medical's Self Expanding Transcatheter Aortic Valve System 
Exhibit 2-19: Sorin's Perceval Valve 
Exhibit 2-20: ValveXchange VXi System 
Exhibit 2-21: Overview of Valve Resection Development Programs, 2009 
Exhibit 2-22: Quaden & Lutter Endoscopic Valve Resection Prototype 
Exhibit 2-23: West German Heart Center Essen, Rotational Valve Resection Prototype 
Exhibit 2-24: TAVI Candidates, 2008 
Exhibit 2-25: Transcatheter Aortic Valve Implantation, U.S. Procedure Forecast by Source, 2011-2015 
Exhibit 2-26: Transcatheter Aortic Valve Implantation, U.S. Procedure Forecast by Approach, 2011-2015 
Exhibit 2-27: Projected Rollout of Selected TAVI Programs 
Exhibit 2-28: Transcatheter Aortic Valve Implantation, U.S. Market Forecast, 2011-2015 

3.0 TRANSCATHETER MITRAL VALVE REPAIR

3.1 Etiology 
	3.1.1 Degenerative Mitral Valve Regurgitation 
	3.1.2 Functional Mitral Valve Regurgitation 
	3.1.3 Other Mitral Valve Regurgitation 
3.2 Transcatheter Approaches 
	3.2.1 Edge-To-Edge Repair 
	3.2.2 Coronary Sinus Annuloplasty 
	3.2.3 Mitral Valve Remodeling 
	3.2.4 Direct Annuloplasty 
	3.2.5 Chordal Replacement 
3.3 Technologies 
3.4 Procedure Forecast 
3.5 Market Analysis 

Exhibit 3-1: Mechanisms of Mitral Regurgitation 
Exhibit 3-2: Characterization of Major Types of Mitral Regurgitation 
Exhibit 3-3: Major Etiologies of Degenerative Mitral Valve Disease 
Exhibit 3-4: Comparison of Transcatheter Approaches to Mitral Valve Repair 
Exhibit 3-5: Selected Transcatheter Mitral Valve Repair Programs, 2009 
Exhibit 3-6: Ample Medical Percutaneous Septal Sinus Shortening (PS3) System 
Exhibit 3-7: Babic Chordal Replacement Technique and Devices 
Exhibit 3-8: Cardiac Dimensions Carillon Mitral Contour System 
Exhibit 3-9: Cardiosolutions' Percu-Pro System 
Exhibit 3-10: Cordis' Direct Plication Annuloplasty (DPA) System 
Exhibit 3-11: Edwards Lifesciences' MOBIUS Leaflet Repair System 
Exhibit 3-12: Edwards Lifesciences MONARC Coronary Annuloplasty System 
Exhibit 3-13: Myocor iCoapsys System 
Exhibit 3-14: Evalve MitraClip System 
Exhibit 3-15: Guided Delivery Systems' AccuCinch 
Exhibit 3-16: Mardil BACE Device 
Exhibit 3-17: MiCardia Dynamic Annuloplasty Platform 
Exhibit 3-18: Mitralign Percutaneous Annuloplasty System 
Exhibit 3-19: QuantumCor RF Mitral Annuloplasty Technology 
Exhibit 3-20: ProRhythm HIFU Mitral Annulus Reduction Technology 
Exhibit 3-21: Viacor Percutaneous Transvenous Mitral Annuloplasty Technology 
Exhibit 3-22: TMVR, U.S. Procedure Forecast by Source, 2010-2015 
Exhibit 3-23: TMVR, U.S. Procedure Forecast by Approach, 2010-2015 
Exhibit 3-24: TMVR Technologies, U.S. Market Forecast, 2010-2015 

4.0 OTHER TRANSCATHETER VALVE TECHNOLOGIES

4.1 Transcatheter Pulmonary Valve Implantation 
	4.1.1 Products and Suppliers 
	4.1.2 Procedure Forecast 
	4.1.3 Market Analysis 
4.2 Transcatheter Mitral Valve Implantation 
	4.2.1 Companies, Programs, Approaches
	4.2.2 Market Assessment 

Exhibit 4-1: Transcatheter Pulmonary Valve Implantation Programs, 2009 
Exhibit 4-2: The Cook-SIS Valve 
Exhibit 4-3: Medtronic Melody Transcatheter Pulmonary Valve 
Exhibit 4-4: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar 
Exhibit 4-5: Custom TPV Implant for Transapical Delivery 
Exhibit 4-6: Custom Valved Stent for Transventricular Pulmonary Implantation 
Exhibit 4-7: Downsize Stent for TPVI 
Exhibit 4-8: U.S. Transcatheter Pulmonary Valve Implantation Procedures, 2009-2015 
Exhibit 4-9: U.S. Transcatheter Pulmonary Valve Implantation Market, 2009-2015 
Exhibit 4-10: Selected Transcatheter Mitral Valve Replacement Programs, 2009 
Exhibit 4-11: CardiAQ Valve Technologies PMVR 
Exhibit 4-12: The Endovalve Mitral Replacement Prosthesis 
Exhibit 4-13: Transapical Mitral Valve Replacement System 
Exhibit 4-14: Double-Crowned Valved Stent for Transatrial Mitral Replacement 

5.0 PERCUTANEOUS BALLOON VALVULOPLASTY

5.1 Clinical Applications 
5.2 Procedure 
5.3 Single versus Double Balloon Techniques 
5.4 Clinical Outcomes 
5.5 Products and Suppliers 
5.6 Procedure Forecast 
5.7 Market Analysis 

Exhibit 5-1: AHA/ACC Recommendations for Percutaneous Balloon Valvuloplasty 
Exhibit 5-2: Selected Studies Comparing Single and Double Balloon Valvuloplasty 
Exhibit 5-3: Selected Studies of PBV for Mitral Stenosis 
Exhibit 5-4: Reported Complications in Aortic Valvuloplasty Registries 
Exhibit 5-5: A Thirty-Year Experience with Aortic Valve Stenosis 
Exhibit 5-6: Selected Percutaneous Balloon Valvuloplasty Catheters, 2009 
Exhibit 5-7: Percutaneous Balloon Valvuloplasty, U.S. Procedure Forecast, 2008-2015
Exhibit 5-8: Percutaneous Balloon Valvuloplasty, U.S. Market Forecast, 2008-2015 
Exhibit 5-9: Percutaneous Balloon Valvuloplasty, U.S. Supplier Shares, 2008

Company listing available upon request.

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