Table of Contents

Executive Summary ………………………………………………………………………. ES-1
i. Heart valve disorders overview ……………………………………………………………………………..ES-1
ii. Global minimally invasive heart valve repair and replacement devices………………………ES-1
a. Market drivers and limiters……………………………………………………………………….ES-3
b. Device segment insights …………………………………………………………………………..ES-4
c. Technology trends……………………………………………………………………………………ES-4
d. Market leaders………………………………………………………………………………………..ES-5
e. Competitive strategies……………………………………………………………………………..ES-5
f. Emerging competition ………………………………………………………………………………ES-6
iii. Methodology……………………………………………………………………………………………………..ES-6

Exhibit ES-1: Transcatheter heart valve management products, global market forecast, 2018-23……………………………………………………………………………………………………..ES-2
Exhibit ES-2: Transcatheter heart valve management products market, global share by country/region, 2018…………………………………………………………………………………..ES-3
Exhibit ES-3: Transcatheter heart valve management products, global market forecast ($m), by product segment, 2018-23……………………………………………………………………….ES-4

1. Heart Valve Disorders Overview…………………………………………………….1-1
1.1 Types of heart valve disorders……………………………………………………………………………. 1-3
1.1.1 Valvular stenosis………………………………………………………………………………… 1-3
1.1.2 Tricuspid valve/pulmonary valve stenosis……………………………………………… 1-4
1.1.3 Valvular regurgitation …………………………………………………………………………. 1-4
1.1.4 Valve prolapse……………………………………………………………………………………. 1-8
1.2 Conditions associated with heart valve disorders…………………………………………………. 1-8
1.2.1 Congenital defects ……………………………………………………………………………. 1-10
1.2.2 Acquired disorders……………………………………………………………………………. 1-10
1.2.3 Calcific degeneration ………………………………………………………………………… 1-10
1.2.4 Infective endocarditis ……………………………………………………………………….. 1-10
1.2.5 Rheumatic fever……………………………………………………………………………….. 1-11
1.2.6 Heart failure…………………………………………………………………………………….. 1-13
1.3 Heart valve diagnosis………………………………………………………………………………………. 1-13
1.4 Heart valve disease treatment options………………………………………………………………. 1-14
1.4.1 Pharmaceutical treatments ……………………………………………………………….. 1-14
1.4.2 Surgical and other interventional solutions………………………………………….. 1-15
1.5 Bibliography …………………………………………………………………………………………………… 1-16

Exhibit 1-1: Progression of valvular heart disease………………………………………………………. 1-2
Exhibit 1-2: Euro Heart Survey on Valvular Heart Disease patient population,
native heart valve disorders, by type …………………………………………………………….. 1-6
Exhibit 1-3: Types and causes of chronic mitral valve regurgitation ……………………………… 1-7
Exhibit 1-4: Types of valvular heart disease and associated conditions and diseases ……… 1-9

2. Transcatheter Heart Valve Management Products……………………………2-1
2.1 Transcatheter aortic valve replacement………………………………………………………………. 2-1
2.1.1 Trials ………………………………………………………………………………………………… 2-2
2.1.2 Products……………………………………………………………………………………………. 2-3
2.1.3 Emerging TAVR products …………………………………………………………………….. 2-6
2.2 Transcatheter mitral valve replacement………………………………………………………………. 2-7
2.3 Transcatheter mitral valve repair (TMVRep) therapy…………………………………………… 2-11
2.3.1 Edge-to-edge repair………………………………………………………………………….. 2-11
2.3.2 Enhanced caption/leaflet spacing……………………………………………………….. 2-12
2.3.3 Coronary sinus annuloplasty………………………………………………………………. 2-12
2.3.4 Direct annuloplasty …………………………………………………………………………… 2-13
2.3.5 The chordal approach ……………………………………………………………………….. 2-14
2.4 Bibliography …………………………………………………………………………………………………… 2-17

Exhibit 2-1: Selected transcatheter aortic valve replacement products, 2019 ……………….. 2-6
Exhibit 2-2: Selected emerging transcatheter aortic valve replacement products, 2019 …. 2-7
Exhibit 2-3: Challenges of TMVR compared to TAVR…………………………………………………… 2-8
Exhibit 2-4: Selected transcatheter mitral and tricuspid valve replacement products, 2019………………………………………………………………………………………….. 2-10
Exhibit 2-5: Selected current and emerging transcatheter mitral valve repair products, 2019………………………………………………………………………………………….. 2-15

3. Transcatheter Heart Valve Products Market…………………………………….3-1
3.1 Global market…………………………………………………………………………………………………… 3-1
3.1.1 Market value……………………………………………………………………………………… 3-2
3.1.2 Technology trends………………………………………………………………………………. 3-6
3.1.3 Market drivers and limiters………………………………………………………………….. 3-8
3.1.4 Transcatheter versus surgical heart valve management options………………. 3-9
3.1.5 Market leaders and competitive strategies………………………………………….. 3-13
3.2 Global competitors by product…………………………………………………………………………. 3-14
3.2.1 Transcatheter aortic valve replacement………………………………………………. 3-14
3.2.2 Transcatheter mitral valve repair ……………………………………………………….. 3-16
3.3 Market forecast………………………………………………………………………………………………. 3-18
3.3.1 Market forecast: US ………………………………………………………………………….. 3-18
3.3.2 Market forecast: five major EU markets………………………………………………. 3-25
3.3.3 Market forecast: Japanese market ……………………………………………………… 3-32
3.3.4 Market forecast: rest of world……………………………………………………………. 3-38

3.4 Bibliography …………………………………………………………………………………………………… 3-47

Exhibit 3-1: Transcatheter heart valve management products, global market forecast, 2018-23……………………………………………………………………………………………………… 3-3
Exhibit 3-2: Transcatheter heart valve management products, global market forecast ($m), by product segment, 2018-23……………………………………………………………………….. 3-4
Exhibit 3-3: Transcatheter heart valve management products market, global share by country/region, 2018…………………………………………………………….. 3-5
Exhibit 3-4: Transcatheter heart valve management products, global market forecast ($m), by country/region, 2018-23………………………………………………………………………….. 3-6
Exhibit 3-5: Comparison of transcatheter and surgical aortic valve replacement………….. 3-12
Exhibit 3-6: Transcatheter heart valve management products market, global share by supplier, 2018…………………………………………………………………….. 3-14
Exhibit 3-7: Trancatheter aortic valve replacment products market, global share by supplier, 2018…………………………………………………………………….. 3-16
Exhibit 3-8: Transcatheter mitral valve repair products market, global share by supplier, 2018…………………………………………………………………….. 3-18
Exhibit 3-9: US transcatheter heart valve management, procedure volumes forecast, 2018-23……………………………………………………………………………………………………. 3-20
Exhibit 3-10: US transcatheter heart valve market forecast ($m), by product segment, 2018-23……………………………………………………………………………………………………. 3-21
Exhibit 3-11: US transcatheter aortic valve replacement products, market forecast ($m), 2018-23……………………………………………………………………………………………………. 3-22
Exhibit 3-12: US transcatheter aortic valve replacement products market, share by supplier, 2018………………………………………………………………………………. 3-23
Exhibit 3-13: US transcatheter mitral valve repair products, market forecast ($m), 2018-23……………………………………………………………………………………………………. 3-24
Exhibit 3-14: 5EU transcatheter heart valve management, procedure volumes forecast, 2018-23……………………………………………………………………………………………………. 3-26
Exhibit 3-15: 5EU transcatheter heart valve management products, market forecast ($m), by product segment, 2018-23……………………………………………………………………… 3-27
Exhibit 3-16: 5EU transcatheter aortic valve replacement products, market forecast ($m), 2018-23……………………………………………………………………………………………………. 3-28
Exhibit 3-17: 5EU transcatheter aortic valve replacement products market, share by supplier, 2018………………………………………………………………………………. 3-29
Exhibit 3-18: 5EU transcatheter mitral valve repair products, market forecast ($m), 2018-23……………………………………………………………………………………………………. 3-31
Exhibit 3-19: 5EU transcatheter mitral valve repair products market, share by supplier, 2018………………………………………………………………………………. 3-32
Exhibit 3-20: Japan transcatheter heart valve management, procedure volumes forecast, 2018-23……………………………………………………………………………………………………. 3-34
Exhibit 3-21: Japan transcatheter heart valve management products, market forecast ($m), by product segment, 2018-23 …………………………………….. 3-35
Exhibit 3-22: Japan transcatheter aortic valve replacement products, market forecast ($m), 2018-23……………………………………………………………………. 3-36
Exhibit 3-23: Japan transcatheter aortic valve replacement products market, share by supplier, 2018………………………………………………………………………………. 3-37
Exhibit 3-24: Japan transcatheter mitral valve repair products, market forecast ($m), 2018-23……………………………………………………………………………………………………. 3-37
Exhibit 3-25: Rest of world transcatheter heart valve management, procedure volumes forecast, 2018-23………………………………………………………….. 3-40
Exhibit 3-26: Rest of world transcatheter heart valve management products, market forecast ($m), by product segment, 2018-23 …………………………………….. 3-41
Exhibit 3-27: Rest of world transcather aortic valve replacement products, market forecast ($m), 2018-23……………………………………………………………………. 3-43
Exhibit 3-28: Rest of world transaortic valve replacement products market, share by supplier, 2018………………………………………………………………………………. 3-44
Exhibit 3-29: Rest of world transcatheter mitral valve repair products, market forecast ($m), 2018-23……………………………………………………………………. 3-45
Exhibit 3-30: Rest of world transcatheter mitral valve repair products market, share by supplier, 2018………………………………………………………………………………. 3-46

Appendix: Company Listing……………………………………………………………… A-1