Valve Diameter Dimensions

Valve Diameter Dimensions
The Aortic Valve Guide
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
Measurements that
affect valve selection
For a given ED, the labeled size and the ID can vary significantly from
product to product.
Examples with same ED (mm)
ED
Mitroflow
Mosaic Ultra / Hancock II Ultra
PERIMOUNT valve
Magna Ease valve
OD
ID
26
23
19
26
21
18.5
26
19
18
26
21
20
(Labeled Size)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic
bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349.
2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
The ID identifies the largest potential diameter of the valve opening;
Brief Summary: Aortic Bioprostheses
Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.
Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects:
stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve
deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any
of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in
the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children,
adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence
of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
the larger the ID, the better the hemodynamic performance.1
Examples of OD (mm)
Mitroflow
OD (Labeled Size)
Mosaic Ultra /
Hancock II Ultra
PERIMOUNT
valve
Magna Ease
valve
Internal Diameter (ID)
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions
and
adverse
events.
Edwards
Lifesciences
Irvine, USAand
Switzerland
Tokyo, Japan
SingaporeCorporation.
Brazil
I Nyon,
I Singapore,
I São Paulo, Edwards
Edwards
Magna
Ease are Itrademarks
of Edwards
Lifesciences
Lifesciences, the stylized E logo,
edwards.com
Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in
the United States Patent and Trademark Office.
19
15.4
17.5
18
18
21
17.3
18.5
20
20
23
19
20.5
22
22
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are
trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil
edwards.com
There is More to Valve Dimension
Than the Labeled Size
1,2
Bioprosthetic
Aortic Valve
Dimensions measured in mm*
I
I
I
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
LABELED SIZE
(OD) (mm)
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
19
pericardial aortic bioprosthesis, as well as competitive valves from
Tokyo, Japan
Singapore, Singapore
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
Magna Ease valve
18
24
0.75
Magna valve
18
24
PERIMOUNT valve
18
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
St. Jude Medical, Medtronic, and Sorin.
São Paulo, Brazil
Mitroflow
LABELED SIZE
(OD) (mm)
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
13
Magna Ease valve
24
30
0.80
16
0.75
14
Magna valve
24
30
0.80
17
26
0.69
14
PERIMOUNT valve
24
32
0.75
17
17.5
25
0.70
13.5
Mosaic / Hancock II
22.5
33
0.68
17.5
17.5
24
0.73
13.5
Mosaic Ultra / Hancock II Ultra
22.5
30
0.75
17.5
19
25
0.76
14
Epic / SJM Biocor
23
29
0.79
16
15.4
21
0.73
11
Epic Supra / SJM Biocor Supra
25
31
0.81
17
Mitroflow
21
29
0.72
15
25
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
21
• Profile Height: The total height of the valve
Magna Ease valve
20
26
0.77
14
Magna Ease valve
26
32
0.81
17
Magna valve
20
26
0.77
15
Magna valve
26
32
0.81
18
PERIMOUNT valve
20
28
0.71
15
PERIMOUNT valve
26
35
0.74
18
Mosaic / Hancock II
18.5
27
0.69
15
Mosaic / Hancock II
24
36
0.67
18.5
Mosaic Ultra / Hancock II Ultra
18.5
26
0.71
15
Mosaic Ultra / Hancock II Ultra
24
32
0.75
18.5
Epic / SJM Biocor
19
25
0.76
14
Epic / SJM Biocor
25
31
0.81
17
Epic Supra / SJM Biocor Supra
21
28
0.75
15
Epic Supra / SJM Biocor Supra
27
33
0.82
19
17.3
23
0.75
13
Mitroflow
22.9
31
0.74
16
Magna Ease valve
22
28
0.79
15
Magna Ease valve
28
34
0.82
18
Magna valve
22
28
0.79
16
Magna valve
28
34
0.82
19
PERIMOUNT valve
22
31
0.71
16
PERIMOUNT valve
28
37
0.76
19
Mosaic / Hancock II
20.5
30
0.68
16
Mosaic / Hancock II
26
39
0.67
20
Mosaic Ultra / Hancock II Ultra
20.5
28
0.73
16
Mosaic Ultra / Hancock II Ultra
26
34
0.76
20
Epic / SJM Biocor
21
27
0.78
15
Epic / SJM Biocor
27
33
0.82
19
Epic Supra / SJM Biocor Supra
23
29
0.79
16
Mitroflow
24.7
33
0.75
16
Mitroflow
19
26
0.73
14
Mitroflow
Profile
Height
23
ID
OD
Labeled Size
ED
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
27
29
edwards.com
There is More to Valve Dimension
Than the Labeled Size
1,2
Bioprosthetic
Aortic Valve
Dimensions measured in mm*
I
I
I
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
LABELED SIZE
(OD) (mm)
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
19
pericardial aortic bioprosthesis, as well as competitive valves from
Tokyo, Japan
Singapore, Singapore
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
Magna Ease valve
18
24
0.75
Magna valve
18
24
PERIMOUNT valve
18
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
St. Jude Medical, Medtronic, and Sorin.
São Paulo, Brazil
Mitroflow
LABELED SIZE
(OD) (mm)
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
13
Magna Ease valve
24
30
0.80
16
0.75
14
Magna valve
24
30
0.80
17
26
0.69
14
PERIMOUNT valve
24
32
0.75
17
17.5
25
0.70
13.5
Mosaic / Hancock II
22.5
33
0.68
17.5
17.5
24
0.73
13.5
Mosaic Ultra / Hancock II Ultra
22.5
30
0.75
17.5
19
25
0.76
14
Epic / SJM Biocor
23
29
0.79
16
15.4
21
0.73
11
Epic Supra / SJM Biocor Supra
25
31
0.81
17
Mitroflow
21
29
0.72
15
25
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
21
• Profile Height: The total height of the valve
Magna Ease valve
20
26
0.77
14
Magna Ease valve
26
32
0.81
17
Magna valve
20
26
0.77
15
Magna valve
26
32
0.81
18
PERIMOUNT valve
20
28
0.71
15
PERIMOUNT valve
26
35
0.74
18
Mosaic / Hancock II
18.5
27
0.69
15
Mosaic / Hancock II
24
36
0.67
18.5
Mosaic Ultra / Hancock II Ultra
18.5
26
0.71
15
Mosaic Ultra / Hancock II Ultra
24
32
0.75
18.5
Epic / SJM Biocor
19
25
0.76
14
Epic / SJM Biocor
25
31
0.81
17
Epic Supra / SJM Biocor Supra
21
28
0.75
15
Epic Supra / SJM Biocor Supra
27
33
0.82
19
17.3
23
0.75
13
Mitroflow
22.9
31
0.74
16
Magna Ease valve
22
28
0.79
15
Magna Ease valve
28
34
0.82
18
Magna valve
22
28
0.79
16
Magna valve
28
34
0.82
19
PERIMOUNT valve
22
31
0.71
16
PERIMOUNT valve
28
37
0.76
19
Mosaic / Hancock II
20.5
30
0.68
16
Mosaic / Hancock II
26
39
0.67
20
Mosaic Ultra / Hancock II Ultra
20.5
28
0.73
16
Mosaic Ultra / Hancock II Ultra
26
34
0.76
20
Epic / SJM Biocor
21
27
0.78
15
Epic / SJM Biocor
27
33
0.82
19
Epic Supra / SJM Biocor Supra
23
29
0.79
16
Mitroflow
24.7
33
0.75
16
Mitroflow
19
26
0.73
14
Mitroflow
Profile
Height
23
ID
OD
Labeled Size
ED
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
27
29
edwards.com
There is More to Valve Dimension
Than the Labeled Size
1,2
Bioprosthetic
Aortic Valve
Dimensions measured in mm*
I
I
I
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
LABELED SIZE
(OD) (mm)
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
19
pericardial aortic bioprosthesis, as well as competitive valves from
Tokyo, Japan
Singapore, Singapore
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
Magna Ease valve
18
24
0.75
Magna valve
18
24
PERIMOUNT valve
18
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
St. Jude Medical, Medtronic, and Sorin.
São Paulo, Brazil
Mitroflow
LABELED SIZE
(OD) (mm)
AORTIC BIOPROSTHESES
ID
ED
ID/ED
RATIO
PROFILE
HEIGHT
13
Magna Ease valve
24
30
0.80
16
0.75
14
Magna valve
24
30
0.80
17
26
0.69
14
PERIMOUNT valve
24
32
0.75
17
17.5
25
0.70
13.5
Mosaic / Hancock II
22.5
33
0.68
17.5
17.5
24
0.73
13.5
Mosaic Ultra / Hancock II Ultra
22.5
30
0.75
17.5
19
25
0.76
14
Epic / SJM Biocor
23
29
0.79
16
15.4
21
0.73
11
Epic Supra / SJM Biocor Supra
25
31
0.81
17
Mitroflow
21
29
0.72
15
25
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
21
• Profile Height: The total height of the valve
Magna Ease valve
20
26
0.77
14
Magna Ease valve
26
32
0.81
17
Magna valve
20
26
0.77
15
Magna valve
26
32
0.81
18
PERIMOUNT valve
20
28
0.71
15
PERIMOUNT valve
26
35
0.74
18
Mosaic / Hancock II
18.5
27
0.69
15
Mosaic / Hancock II
24
36
0.67
18.5
Mosaic Ultra / Hancock II Ultra
18.5
26
0.71
15
Mosaic Ultra / Hancock II Ultra
24
32
0.75
18.5
Epic / SJM Biocor
19
25
0.76
14
Epic / SJM Biocor
25
31
0.81
17
Epic Supra / SJM Biocor Supra
21
28
0.75
15
Epic Supra / SJM Biocor Supra
27
33
0.82
19
17.3
23
0.75
13
Mitroflow
22.9
31
0.74
16
Magna Ease valve
22
28
0.79
15
Magna Ease valve
28
34
0.82
18
Magna valve
22
28
0.79
16
Magna valve
28
34
0.82
19
PERIMOUNT valve
22
31
0.71
16
PERIMOUNT valve
28
37
0.76
19
Mosaic / Hancock II
20.5
30
0.68
16
Mosaic / Hancock II
26
39
0.67
20
Mosaic Ultra / Hancock II Ultra
20.5
28
0.73
16
Mosaic Ultra / Hancock II Ultra
26
34
0.76
20
Epic / SJM Biocor
21
27
0.78
15
Epic / SJM Biocor
27
33
0.82
19
Epic Supra / SJM Biocor Supra
23
29
0.79
16
Mitroflow
24.7
33
0.75
16
Mitroflow
19
26
0.73
14
Mitroflow
Profile
Height
23
ID
OD
Labeled Size
ED
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
27
29
Valve Diameter Dimensions
The Aortic Valve Guide
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
Measurements that
affect valve selection
For a given ED, the labeled size and the ID can vary significantly from
product to product.
Examples with same ED (mm)
ED
Mitroflow
Mosaic Ultra / Hancock II Ultra
PERIMOUNT valve
Magna Ease valve
OD
ID
26
23
19
26
21
18.5
26
19
18
26
21
20
(Labeled Size)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic
bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349.
2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
The ID identifies the largest potential diameter of the valve opening;
Brief Summary: Aortic Bioprostheses
Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.
Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects:
stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve
deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any
of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in
the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children,
adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence
of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
the larger the ID, the better the hemodynamic performance.1
Examples of OD (mm)
Mitroflow
OD (Labeled Size)
Mosaic Ultra /
Hancock II Ultra
PERIMOUNT
valve
Magna Ease
valve
Internal Diameter (ID)
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions
and
adverse
events.
Edwards
Lifesciences
Irvine, USAand
Switzerland
Tokyo, Japan
SingaporeCorporation.
Brazil
I Nyon,
I Singapore,
I São Paulo, Edwards
Edwards
Magna
Ease are Itrademarks
of Edwards
Lifesciences
Lifesciences, the stylized E logo,
edwards.com
Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in
the United States Patent and Trademark Office.
19
15.4
17.5
18
18
21
17.3
18.5
20
20
23
19
20.5
22
22
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are
trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil
Valve Diameter Dimensions
The Aortic Valve Guide
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
Measurements that
affect valve selection
For a given ED, the labeled size and the ID can vary significantly from
product to product.
Examples with same ED (mm)
ED
Mitroflow
Mosaic Ultra / Hancock II Ultra
PERIMOUNT valve
Magna Ease valve
OD
ID
26
23
19
26
21
18.5
26
19
18
26
21
20
(Labeled Size)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic
bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349.
2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
The ID identifies the largest potential diameter of the valve opening;
Brief Summary: Aortic Bioprostheses
Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.
Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects:
stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve
deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any
of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in
the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children,
adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence
of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
the larger the ID, the better the hemodynamic performance.1
Examples of OD (mm)
Mitroflow
OD (Labeled Size)
Mosaic Ultra /
Hancock II Ultra
PERIMOUNT
valve
Magna Ease
valve
Internal Diameter (ID)
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions
and
adverse
events.
Edwards
Lifesciences
Irvine, USAand
Switzerland
Tokyo, Japan
SingaporeCorporation.
Brazil
I Nyon,
I Singapore,
I São Paulo, Edwards
Edwards
Magna
Ease are Itrademarks
of Edwards
Lifesciences
Lifesciences, the stylized E logo,
edwards.com
Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in
the United States Patent and Trademark Office.
19
15.4
17.5
18
18
21
17.3
18.5
20
20
23
19
20.5
22
22
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are
trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Edwards Lifesciences
Irvine, USA I Nyon, Switzerland
edwards.com
I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil