Download Consider Medtronic`s Intuitive Heart Valve Solutions

H E A R T VA LVE S
Seize
Simplicity
Consider Medtronic’s Intuitive Heart Valve Solutions
Simplicity clears the way to let you decide what’s best.
Simplicity
There are many patient considerations,
but only one judgment call.
Consider Medtronic’s intuitive heart valve
solutions in all your decisions.
MOSAIC ®
b io p ro st hesi s
Simply Versatile
Seize simplicity with a versatile platform designed to easily
facilitate aortic or mitral, open or minimally invasive procedures.
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Hancock® II
b io p ro st hesi s
Simply R eliable
Seize simplicity with the valve that has stood the test of time
to make your outcome as predictable as your procedure.
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FREESTYLE ®
a o r t ic ro o t b i o p ro st hesi s
Simply M ore Flow
Seize simplicity with a stentless valve that is naturally
designed to maximize flow, particularly for young patients.
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3f ®
ao r t ic b i o p ro st hesi s
Simply D esigned
Seize simplicity with the first pericardial stentless valve
designed to facilitate ease of implantation.
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medtronic Open pivot
™
hear t valve
Simply Q uiet
Seize Simplicity with a design that provides a valve solution
most patients cannot hear after implantation.
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REpair
Simply Personalized
Seize simplicity with repair products that provide
you options to consider for each individual case.
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Mosaic®
bioprosthesis
hancock® ii
bioprosthesis
Freestyle®
aortic root
bioprosthesis
3f ®
aortic bioprosthesis
medtronic
Open Pivot™
heart valve
repair
• More than 12 years of clinically documented durability in young patients1, 2
• Exceptional durability in the mitral position1
• Ideal for MICS procedures
• Proven durability in all patients regardless of age3
• 25 year data show consistent outcomes 3, 4
• More than 97% freedom from SVD at 20 years3
• Naturally designed to function like the native valve
• Stable, single-digit gradients and EOAs at 12 years5
• 92% freedom from SVD after 12 years in patients 60 and younger 5
• Designed for easier implant with a single suture line
• Simple tubular design preserves sinus form and function6
• Improved stress distribution mimics the functional characteristics of the
native valve7
• So quiet only one in five patients is aware of their valve sound 8
• Gentle passive washing results in low levels of hemolysis and
thromboembolic events 9, 10
• Orifice design and unique leaflet movement result in excellent EOAs,
even in small sizes11
• Intuitive designs of the Tri-Ad® Adams Ring and Contour 3D® Ring adapt to
3D geometry of the tricuspid valve annulus
• Design of Profile 3D® Ring maintains the natural asymmetrical posterior and
anterior dimensions of the mitral annulus
• CG Future® Ring restores the patient’s annular shape and allows natural motion
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Hancock® II Bioprosthesis
Mosaic® Porcine Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral
heart valves. Contraindications: None known. Warnings/Precautions/Adverse Events:
Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in:
children, adolescents, young adults, and patients with altered calcium metabolism (e.g.,
chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac
arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic
anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural
dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.
For additional information, please refer to the Instructions For Use.
References
Jamieson, W.R.E., et al. Medtronic Mosaic porcine bioprosthesis: Assessment of
12-year performance. J Thorac Cardiovasc Surg 2011;142:302-307.
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Riess, F.C. et al., The Mosaic porcine bioprothesis: Role of age on clinical performance in aortic position. J Thorac Cardiovasc Surg 2011;141:1440-8.
David, T., et al., Hancock II Bioprosthesis for aortic valve replacement: The gold
standard of bioprosthetic valves durability. Ann Thorac Surg 2010;90:775-81.
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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Freestyle® Aortic Root Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic valves
with the option of aortic root replacement. Contraindications: None known. Warnings/
Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of
bioprosthesis may occur in: children, adolescents, young adults, and patients with altered
calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can
include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or
paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism,
valve thrombosis, or intracuspal hematoma. For additional information, please refer to the
Instructions For Use.
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Valfre C, et al. The fate of Hancock II porcine valve recipients 25 years after
implant. European Journal of Cardio-Thoracic Surgery 2010;28:141-146.
Freestyle Aortic Root Bioprosthesis 12-year clinical compendium 2010
©Medtronic, Inc. UC200704939a.
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Jin XY, Implications of stentless valve design and implantation techniques for
aortic root geometry [abstract]. Paper presented at: Advanced Cardiac
Techniques in Surgery; May 2-3, 2007; New York, NY.
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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Freestyle, Hancock and Mosaic are registered trademarks of Medtronic, Inc.
Cox J, Ad N., Myers K, Gharib M, Quijano RC. Tubular heart valves: A new tissue
prosthesis design – Preclinical evaluation of the 3f aortic bioprosthesis. J Thoracic
Surg 2005;130:520-7.
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3f® Aortic Bioprosthesis
Indications: The 3f® Aortic Bioprosthesis, Model 1000 is indicated for the replacement of
diseased, damaged, or malfunctioning native or prosthetic aortic valves. Contraindications:
The 3f® Aortic Bioprosthesis, Model 1000 should not be used in those patients who present
with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.
Warnings/Precautions/Side Effects: Accelerated deterioration of the Model 1000 valve due
to calcific degeneration may occur in children, adolescents, or young adults, or in patients
with altered calcium metabolism such as patients on maintenance hemodialysis for chronic
renal failure, patients with hyperparathyroidism, patients on high calcium diets, or patients
requiring chronic calcium-containing drug therapy. The performance of the Model 1000
valve is, as is the case for all stentless bioprosthetic valves, dependent on accurate matching
of the valve to the recipient patient’s aortic annular and sinotubular dimensions and may
be adversely affected by high aortic root compliance. General complications potentially
associated with the use of bioprosthetic heart valves include: leak (transvalvular, perivalvular),
cardiac dysrhythmias, endocarditis, hemolysis, hemorrhage, non-structural dysfunction [NSD]
(entrapment by pannus or suture, inappropriate sizing or positioning, or other), structural
deterioration (intrinsic and extrinsic calcification, leaflet perforation or tear, leaflet thickening,
or myxomatous degeneration), prosthesis stenosis, prosthesis regurgitation, valve thrombosis, thromboembolism.
Sezai A., Shiono M, Orime Y, et al., Evaluation of valve sound and its effects on
ATS prosthetic valves in patients’ quality of life. Ann Thorac Surg. 2000;69:507-512.
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Van Nooten GJ, Caes F, Fancois K, et al., Fifteen years’ single-center experience
with the ATS bileaflet valve, J Heart Valve Dis 2009;18:445-452.
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Shiono M, Sezai A, et al., Multi-institutional experience of the ATS open pivot
bileaflet valve in Japan. Ann Thorac Cardiovasc Surg. 1996;2(1):51-58.
ATS Medical Inc., Pre-market Approval Application – Summary of Safety and
Effectiveness: 2000. Washington, D.C; US. Food and Drug Administration. 2000:
P990046.
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CAUTION: Federal law restricts this device to sale by or on the order of a physician.
This device is restricted to use by a physician who has participated in specific implantation
training for the 3f® Aortic Bioprosthesis, Model 1000.
3f is a registered trademark of 3f Therapeutics, Inc. a subsidiary of Medtronic, Inc.
Duran AnCore® Ring and Band, Simulus® Flexible Ring and Band, Simulus® Adjustable
Ring and Band, Simplici-T® Band, CG Future® Ring and Band, Simulus® Semi-rigid Ring
and Band, Tri-Ad® Adams Ring, Profile 3D® Ring, Contour 3D® Ring
Warnings/Precautions/Adverse Events:
Only physicians who have received proper training in valve repair should use this device.
Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis,
residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular
outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.
For additional information please refer to the Instructions for Use provided with the product
or contact your local Medtronic representative.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic Open Pivot™ Heart Valve
Indications: The Medtronic Open Pivot™ Heart Valve is indicated for the replacement of
diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients
unable to tolerate anticoagulation therapy. Adverse events potentially associated with
the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment
(impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or
perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician or
properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for
a complete listing of warnings and precautions.
Medtronic Open Pivot is a trademark of Medtronic, Inc.
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seizesimplicity.com
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Medtronic, Inc.
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USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
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Asia
Medtronic International Ltd.
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Nasaco Tech Centre
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Singapore
Tel: (65) 6436 5000
Fax: (65) 6776 6335
Canada
Medtronic of Canada Ltd.
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Brampton, Ontario L6Y 0R3
Canada
Tel: (905) 460-3800
Fax: (905) 826-6620
Toll-free: 1 (800) 268-5346
Latin America
Medtronic USA, Inc.
Doral Corporate Center II
3750 NW 87th Avenue Suite 700
Miami, FL 33178
USA
Tel: (305) 500-9328
Fax: (786) 709-4244
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888
E-mail: [email protected]
UC 201204100 EN © Medtronic, Inc. 2012. All Rights Reserved. Printed in USA
www.medtronic.com