Download Surgical Heart Valve Portfolio

SURGICAL
HEART VALVE
PORTFOLIO
Products designed to help
you achieve excellent patient
outcomes while enhancing
your surgical offerings.
INVESTING IN YOU.
WE’RE DEDICATED
TO THE
HEART TEAM
AND THE
LONG-TERM
CARE OF
YOUR PATIENTS
2
INVESTING IN INNOVATION
We strive for continuous innovation — not just for
innovation’s sake, but to truly advance patient care.
INVESTING IN YOUR
EDUCATION AND TRAINING
Our medical education offerings help you stay up-todate on the latest techniques through a combination
of live case observations, didactic sessions, handson experience in pig heart simulation labs, and video
case reviews.
INVESTING IN YOUR PATIENTS
With a focus on your patient’s long-term quality of life,
we work in collaboration with you to develop solutions
that achieve excellent patient outcomes.
3
HEART VALVE REPLACEMENT THERAPIES
UNDENIABLY
DURABLE.
An evolution in durability and implantability
80% freedom from explant due to SVD at
16 years in the mitral position1
81% freedom from explant due to SVD at
17 years in the aortic position2
Cinch™ implant system facilitates ease of
valve implant
Physiologic Fixation promotes long-term
valve durability*
Suitable for future interventions
*No clinical data is available which evaluates the long-term
impact of the Physiologic Fixation process in patients.
4
Mosaic™
Bioprosthesis
HEART VALVE REPLACEMENT THERAPIES
TESTED,
TRUSTED.
More than 30 years delivering consistent performance
and clinical results
97.8% freedom from SVD at 20 years in aortic position3
Impressive long-term performance in all age groups for
both aortic and mitral valve
85% freedom from SVD at 15 years in mitral position4
Suitable for future interventions
Hancock™ II
Bioprosthesis
55
HEART VALVE REPLACEMENT THERAPIES
MAXIMUM
FLOW.
Designed to function like a native valve
with physiologic hemodynamics
Excellent mean pressure gradients and
EOAs out to 10 years5
Strong clinical outcomes and excellent
durability at 15 years6
Freestyle™
Aortic Root Bioprosthesis
6
HEART VALVE REPLACEMENT THERAPIES
PERFORMANCE
IN DESIGN.
Excellent hemodynamics and reduced hemolysis7,8
Unique axis of suspension responds to physiological
demands leading to excellent hemodynamic performance9
Single-plane orifice for implantability
A remarkably quiet valve
Medtronic Open Pivot™
Heart Valve
7
MITRAL REPAIR THERAPIES
PHYSIOLOGICALLY-BASED
ADVANCED SOLUTIONS
Simulus™
Flexible Band
llows for continuous movement
A
and natural flexibility
8
Simulus™
Semi-Rigid Ring & Band
R
estores annular shape while allowing natural
saddle shape to reduce mitral stress
P
rovides posterior support and accommodates
anterior motion
MITRAL REPAIR THERAPIES
CG Future™
Ring & Band
osterior support while preserving annular
P
motion throughout the cardiac cycle10
Profile 3D™
Ring
M
aintains the natural asymmetrical posterior
and anterior dimensions with a saddle shape11
9
TRICUSPID REPAIR THERAPIES
NO LONGER THE
FORGOTTEN VALVE
Tri-Ad™
Adams Ring
Flexible repair with targeted support12
10
Contour 3D™
Ring
A
natomically shaped — 3D remodeling ring
REFERENCES
1. Mosaic Mitral Bioprosthesis 16-year Clinical Compendium. ©2016 Medtronic.
2. Mosaic Aortic Bioprosthesis 17-year Clinical Compendium. ©2016 Medtronic.
3.David T, Armstrong S, Maganti M, Hancock II bioprosthesis for aortic valve replacement: the gold standards of bioprosthetic valves durability?
Ann Thorac Surg 2010;90:775–81.
4. Rizzoli G, et al. Fifteen-year results with the Hancock II valve: A multicenter experience. J Thorac Cardiovasc Surg 2006;132:602-9.
5. Freestyle Aortic Root Bioprosthesis 12-year Clinical Compendium. ©2007 Medtronic.
6. Freestyle Aortic Root Bioprosthesis 15-year Clinical Compendium. ©2016 Medtronic.
7.Shiono M, Sezai Y, Sezai A, et al. Multi-institutional experience of the ATS open pivot bileaflet valve in Japan. Ann Thorac Cardiovasc Surg. 1996.2(1):51-8.
8.Krian A. Clinical results of a large series of ATS valve implants. In: Krian A, Matloff JM, Nicoloff DM, eds. Advancing the technology of bileaflet mechanical
heart valves:Springer Verlag; 1998:53-71.
9. Feng Z, et al. In vitro hydrodynamic characteristics among three bileaflet valves in the mitral position. Artif Organs. 2000;24(5):346-54.
10. Redmond J, et al. In-vivo motion of mitral valve annuloplasty devices. J of Heart Valve Dis 2007;17:110-8.
11.Guenzinger R, et al. Is a profiled annuloplasty ring suitable for repair of degenerative mitral regurgitation? A single-center experience comprising 200
patients. Thorac Cardiovasc Surg. 2015 Sep 3 Epub ahead of print.
12.Milla F, et al. Rationale and initial experience with the Tri-Ad Adams tricuspid annuloplasty ring. J Thorac Cardiovasc Surg. 2012;143:S71-3. doi: 10.1016/j.
jtcvs.2011.11.015. Epub 2012 Jan 24.
11
Hancock II Bioprosthesis Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral 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.
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.
Mosaic 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.
Medtronic Open Pivot Heart Valve - Important Labeling Information for United States 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. Warning: Persons allergic
to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Adverse events potentially associated
with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related
hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular
leak, transvalvular leak, thrombosis, stroke, thromboembolism. It is possible that these complications could lead to: reoperation, explantation,
permanent disability, heart failure, death.
Medtronic Open Pivot Heart Valve - Important Labeling Information for Geographies Outside of the United States Indications: The
Medtronic Open Pivot Heart Valve is intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning heart
valves. This device may also be used to replace a previously implanted prosthetic heart valve. Contraindications: The Medtronic Open Pivot
Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Warning: Persons allergic to cobalt, chromium, or nickel
may suffer an allergic reaction to this device. Adverse events potentially associated with the use of prosthetic heart valves include: angina,
cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment
(impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke,
thromboembolism. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.
Tri-Ad Adams Tricuspid Ring Indications: Tri-Ad Adams tricuspid annuloplasty rings are for use in patients undergoing surgery for diseased
or damaged tricuspid valves. The Tri-Ad Adams tricuspid annuloplasty ring provides support for and restricts expansion of the annulus.
Contraindications: Severe, generalized or localized bacterial endocarditis, heavily calcified valves, greatly dilated annulus (not reducible
by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with severely reduced
mobility, congenital malformations with lack of valvular tissue. 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, right ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax:(763) 514-4879
Toll-free: (800) 328-2518
medtronic.com
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax:(763) 526-7888
[email protected]
Contour 3D Annuloplasty Ring Indications: The Contour 3D ring is indicated for the reconstruction and/or remodeling of pathological
tricuspid valves. Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
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, right
ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.
Simulus Semi-Rigid Annuloplasty Ring and Band Indications: The Simulus semi-rigid annuloplasty rings and band are for use in patients
undergoing surgery for diseased or damaged mitral valves. The Simulus semi-rigid annuloplasty ring and band provide support for and restrict
expansion of the annulus. Contraindications: Severe, generalized or localized bacterial endocarditis, heavily calcified valves, greatly dilated
annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with
severely reduced mobility, congenital malformations with lack of valvular tissue. 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.
Simulus Flexible Annuloplasty Ring and Band Indications: The Simulus Flexible Annuloplasty Ring and Band are for use in those patients
undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by
employing the appropriate surgical repair. The annuloplasty ring and band provide support for the mitral or tricuspid annulus and restrict
expansion of the annulus. Contraindications: Severe, generalized or localized bacterial endocarditis, heavily calcified valves, greatly dilated
annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with
severely reduced mobility, congenital malformations with lack of valvular tissue. 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.
CG Future Annuloplasty Ring and Band Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral
valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. Contraindications: Heavily
calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis. 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.
Profile 3D Annuloplasty Ring Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves.
Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. Contraindications: Heavily calcified
valves, valvular retraction with severely reduced mobility, active bacterial endocarditis. Warnings/Precautions/Adverse Events: Only
physicians who have received proper training in valve repair should use this device. Adverse events can include: thromoboembolic events,
dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract
obstruction, anticoagulant-related bleeding or hemorrhage.
For a listing of indications, contraindications, precautions, warnings, and potential
adverse events, please refer to the Instructions for Use. For countries that use
eIFUs, consult instructions for use at this website www.medtronic.com/manuals.
Note: Manuals can be viewed using a current version of any major internet browser
Caution: Federal law (USA) restricts these devices to sale by or on the order
of a physician.
©2017 Medtronic. All rights reserved.
Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic.
All other brands are trademarks of a Medtronic company.
UC201606742a EN
02/2017