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3f ® Aortic Bioprosthesis

The Only Pericardial Platform Designed for Native Hemodynamics

Innovative Pericardial Platform

The 3f® Aortic Bioprosthesis is the only pericardial tissue valve designed to function like a native human aortic valve. Because of a tubular design, the valve does not disrupt the geometry of the native sinuses, allowing maximum flow through the orifice.

3f ® Aortic Bioprosthesis

The Only Pericardial Platform Designed for Native Hemodynamics

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Risks: As with any open chest procedure, certain complications may occur. The adverse events potentially associated with the use of bioprosthetic heart valves include, but are not limited to: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, anticoagulant/antiplatelet-related leak, transvalvular or paravalvular, nonstructural dysfunction (pannus, suture inappropriate sizing, or other), structural deterioration (calcification, leaflet tear, or other), thromboembolism, valve thrombosis and intracuspal hematoma.

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is the 3f® Aortic Bioprosthesis?

The design of the Medtronic 3f® Aortic Bioprosthesis is based on the engineering concept that "form follows function."1 Mimicking the native aortic valve's function as a tubular structure whose sides collapse in response to pressure, the 3f Aortic Bioprosthesis reproduces the functional characteristics of the native aortic valve. The 3f Aortic Bioprosthesis is uniquely constructed of three equine pericardial leaflets shaped in the form of a tube. A large area of leaflet coaptation mimics the native aortic valve and can compensate for naturally occurring changes within the aortic root, which may explain a low incidence of central prosthetic regurgatation.2

What

Commissural tabs attach directly to the native aortic wall

Made of equine pericardium, which is strong and pliable Slightly scalloped inflow edge to mimic the natural aortic valve Thin layer of polyester material makes up a single suture line for ease of implant Surgeon's flags and suture demarcation line

the 3f® Aortic Bioprosthesis works?

How

Preserves Aortic Sinuses

The 3f® Aortic Bioprosthesis maintains continuity between the annulus and the sinotubular junction. Without a second suture line, it preserves sinus form and function.3

3f Aortic Bioprosthesis

Native Aortic Valve

Restores Native Stress Distribution

The 3f® Aortic Bioprosthesis is designed to restore native valve stress distribution to the entire aortic root.1 Unlike other commercially available tissue valves where the greatest stress is on the commissures, the 3f valve's greatest stress is toward the semilunar "belly" of the cusps--as observed in healthy aortic valves.1

Semilunar "belly"

Highest Stress

Lowest Stress

Mean Pressure Gradient (mm Hg)

Survival (%)

the 3f® Aortic Bioprosthesis?

For more information about the 3f Aortic Bioprosthesis, or for information about training opportunities, contact your Medtronic representative or call 1 (877) 526-7890.

Why

325 Implants 46 Centers in North America Patients enrolled: 405 Number of centers: 23 Patient years: 1,165 Number patients at risk at 60 months: 32

Excellent Hemodynamics

Tubular in design, the 3f® Aortic Bioprosthesis restores physiologic, non-turbulent transvalvular flow that is nearly indistinguishable from flow across a native aortic valve.1

North American Hemodynamic Performance Post-Operative Mean Gradients

8 7 6 5 4 3 2 1 0

Source: 3f Implant Surveys, Data on file.

6.8

6.5

6.1 4.8 4.2

21 mm

23 mm

25 mm Valve Size

27 mm

29 mm

Durability Performance

Freedom From Structural Valve Dysfunction

100 80 60 40 20 0 0 6 12 18 24 30 36 42 48 54 60 66

Source: 3f PMA Clinical Data.

99.7%

Months Post Implant

Ordering Information

3f® Aortic Bioprosthesis Valve Size (mm) Order Number A (mm) B (mm) C (mm) D (mm)

C D A

19 * 21 23 25 27

1000-19 1000-21 1000-23 1000-25 1000-27 1000-29

23 25 27 29 31 32

19 21 23 25 27 29

6.0 6.0 6.0 6.0 6.7 7.0

8.9 9.6 10.0 10.4 11.4 11.9

B

29

* Not available in the United States

Accessories Model Number Order Number

Sizer Set

5000

5000

References 1. 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. 2. Pillai R, Ratnatunga C, Soon JL, et al. 3f Prosthesis Aortic Cusp Replacement: Implantation Technique and Early Results. Asian Cardiovasc Thorac Ann 2010;18:13-16. 3. Jin XY. Implications of Stentless Valve Design and Implantation Tchniques for Aortic Root Geometry [abstract]. Paper presented at: Advanced Cardiac Techniques in Surgery; May 2-3, 2007; New York, NY.

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 pa tients 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. 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 Medtronic, Inc.

www.medtronic.com

World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 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) Europe Medtronic International Trading Sàrl Route du Molliau 31 Case postale CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900 Canada Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Canada Tel: (905) 826-6020 Fax: (905) 826-6620 Toll-free: 1 (800) 268-5346 Asia Pacific Medtronic International, Ltd. 16/F Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel: (852) 2891 4456 Fax: (852) 2891 6830 [email protected] 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

UC201103806 EN © Medtronic, Inc. 2010. All Rights Reserved. Printed in USA.

LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 E-mail: [email protected]

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