SURGICALHEART VALVE PORTFOLIOProducts 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 INNOVATIONWe strive for continuous innovation — not just for innovation’s sake, but to truly advance patient care.

INVESTING IN YOUR EDUCATION AND TRAININGOur medical education offerings help you stay up-to-date on the latest techniques through a combination of live case observations, didactic sessions, hands-on experience in pig heart simulation labs, and video case reviews.

INVESTING IN YOUR PATIENTSWith 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.

Mosaic™ Bioprosthesis

4

5

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

5

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

PERFORMANCEIN 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

Restores annular shape while allowing natural saddle shape to reduce mitral stress

Provides posterior support and accommodates anterior motion

Simulus™ Flexible Band

Simulus™ Semi-Rigid Ring & Band

PHYSIOLOGICALLY-BASEDADVANCED SOLUTIONS

MITRAL REPAIR THERAPIES

Allows for continuous movement and natural flexibility

8

MITRAL REPAIR THERAPIES

CG Future™ Ring & Band

Posterior support while preserving annular motion throughout the cardiac cycle10

Profile 3D™ Ring

Maintains the natural asymmetrical posterior and anterior dimensions with a saddle shape11

9

TRICUSPID REPAIR THERAPIES

Flexible repair with targeted support12

Tri-Ad™ Adams Ring

NO LONGER THE FORGOTTEN VALVE

Contour 3D™ Ring

Anatomically shaped — 3D remodeling ring

10

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.

Anatomically shaped — 3D remodeling ring

REFERENCES

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.

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.

UC201606742a EN 02/2017

710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Toll-free: (800) 328-2518

LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 rs.cstechsupport@medtronic.com

medtronic.com©2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.