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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. 1 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. 2 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. 3 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. 4 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. 5 REpair Simply Personalized Seize simplicity with repair products that provide you options to consider for each individual case. 6 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 7 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. 1 2 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. 3 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. 4 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. 5 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. 6 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. 7 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. 8 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. 9 10 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. 11 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. 8 seizesimplicity.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 84 CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900 Asia Medtronic International Ltd. 49 Changi South Avenue 2 Nasaco Tech Centre Singapore 486056 Singapore Tel: (65) 6436 5000 Fax: (65) 6776 6335 Canada Medtronic of Canada Ltd. 99 Hereford Street 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