SOLO SMART. The smart way to return to life. Native-like performance now with stented-like implantability
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1 SOLO SMART TM The smart way to return to life Native-like performance now with stented-like implantability
2 MANY PATIENTS NEED SUPERIOR HEMODYNAMIC PERFORMANCE TO RETURN TO THEIR NORMAL LIFESTYLE. 2
3 SOLO SMART TM THE ONLY NATIVE LIKE VALVE WITH S TEN TED-LIKE IMPL AN TABILIT Y SOLO SMART IS PARTICULARLY INDICATED FOR PATIENTS......WITH AN ACTIVE LIFESTYLE During exercise or even during normal daily activities, where there's an increasing cardiac output, some prostheses can obstruct the blood flow. This can lead to higher pressure gradients which are not apparent at rest. Exercise Hemodynamics of Aortic Prostheses: Comparison Between Stentless Bioprostheses and Mechanical Valves. Silberman et al. Ann Thorac Surg 21;72: AT RISK OF PPM When implanting a prosthesis, the presence of PPM can have an impact on patient outcomes. PPM is associated with less improvement in symptoms and functional class, impaired exercise capacity, less regression of LV hypertrophy, and more adverse cardiac events. Prosthetic Heart Valves: Selection of the Optimal Prosthesis and Long-Term Management. P. Pibarot et al. Circulation. 29;119: REQUIRING CONCOMITANT AVR AND MV SURGERY Patients requiring a concomitant procedure can result with a smaller effective aortic area and reduced dynamics due to a constrictive effect of the annuloplasty ring or mitral prosthesis. Effect of Mitral Valve Repair on Mitral-Aortic Coupling: A Real-Time Three-Dimensional Transesophageal Echocardiography Study. Veronesi et al. Journal of the American Society of Echocardiography Vol. 25 N. 5 3
4 SOLO SMART TM allows your patient to live their life without limits. THE ONLY NATIVE LIKE VALVE WITH S TEN TED-LIKE IMPL AN TABILIT Y SOLO SMART TM satisfies both your and your patients needs: The only valve designed to provide superior hemodynamics and clinical outcomes. All the benefits of FREEDOM SOLO now with an easier and smarter implantability. 4
5 SPECIFICALLY DESIGNED FOR PATIENTS REQUIRING SUPERIOR HEMODYNAMIC PERFORMANCE. PRESSURE GRADIENTS PRESSURE GRADIENTS mmhg Size 19 Size 21 Size 23 Size 25 Size 27 Size 19 Size 21 Size 23 Size 25 Size months 12 months MPG PPG MPG PPG Early clinical and hemodynamic results after aortic valve replacement with the FREEDOM SOLO bioprosthesis (experience of Italian multicenter study). A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber Eur J Cardiothorac Surg (212) 41(5): The FREEDOM SOLO Valve for Aortic Valve Replacement: Clinical and Hemodynamic Results from a Prospective Multicenter Trial. S. Beholz, A. Repossini, U. Livi, M. Schepens, M. El Gabry, K. Matschke, U.Trivedi, L. Eckel, O. Dapunt, J.L. Zamorano The Journal of Heart Valve Disease 21;19: SOLO SMART PROVIDES SUPERIOR HEMODYNAMIC PERFORMANCE FOR ALL VALVE SIZES, EVEN THE SMALLEST. 5
6 EOA EOAi 3 2 cm cm 2 / m Size 19 Size 21 Size 23 Size 25 Size months Pre-op 12 months The EOA indices were about 1. cm 2 /m 2 for all valve sizes after 12 months, which suggested almost normal hemodynamics at the valvular level, without any need for annular enlargement procedures. The FREEDOM SOLO Valve for Aortic Valve Replacement: Clinical and Hemodynamic Results from a Prospective Multicenter Trial. S. Beholz, A. Repossini, U. Livi, M. Schepens, M. El Gabry, K. Matschke, U.Trivedi, L. Eckel, O. Dapunt, J.L. Zamorano The Journal of Heart Valve Disease 21;19: EOA EOAi cm cm 2 /m Pre-op 12 months Pre-op 12 months The present study showed that large EOAs and EOAi s remained substantially stable after the first post-operative year. Our data are consistent with previous studies, which demonstrated excellent early clinical and hemodynamic results. Early clinical and hemodynamic results after aortic valve replacement with the FREEDOM SOLO bioprosthesis (experience of Italian multicenter study). A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber Eur J Cardiothorac Surg (212) 41(5): SOLO SMART PROVIDES HEMODYNAMICS, EOA AND EOAI CLOSE TO THOSE OF HEALTHY NATIVE VALVES ENSURING SUPERIOR OUTCOMES AND LOWER RISK OF MISMATCH. 6
7 A VALVE THAT ADAPTS TO THE EVERY DAY NEEDS OF THE PATIENT! Because the Solo Smart TM has no rigid support and is placed supra-annularly it does not restrict the blood flow, offering superior hemodynamics. Hemodynamic performance of Solo Smart under exercise is characterized by: Low gradients under stress Modest mean gradients increase from rest to stress EOA and EOAi increase during exercise Significant LVM regression at 12 months mmhg cm 2 /m Rest Peak stress Rest MPG PPG EOA EOAi Peak stress Early clinical and hemodynamic results after aortic valve replacement with the FREEDOM SOLO bioprosthesis (experience of Italian multicenter study). A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber Eur J Cardiothorac Surg (212) 41(5): THE VALVE MIMICS THE PHYSIOLOGY OF A NATIVE VALVE WITH THE ABILITY OF INCREASING ITS EOA TO RESPOND TO INCREASING PHYSIOLOGIC DEMANDS. 7
8 SOLO SMART EVERYTHING UNDER CONTROL The new Solo Smart maintains the valve geometry and symmetry within the aortic root to simplify implant procedure and suturing. 8 TM
9 EASIER, SMARTER IMPLANT PROCEDURE IMPROVES CONFIDENCE DURING IMPLANTATION Improves visibility of implantation site during valve positioning and suturing. Features a "temporary stent" that gives support and facilitates Solo valve implantation. Less time required to complete valve suturing (more than 2% time reduction). Reduces the learning curve in first time users. ALL THE BENEFITS OF A NATIVE-LIKE VALVE NOW WITH THE EASE OF A STENTED BIOPROSTHESIS IMPLANTATION References: Data on file. 9
10 2/16 RE21178/B Manufactured by: Sorin Group Italia Srl A wholly-owned subsidiary of LivaNova Plc Via Crescentino Saluggia (VC) Italy Теl: Fax: info.cardiacsurgery@livanova.com Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects. 216 LivaNova all rights reserved.
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