MITROFLOW VALSALVA CONDUIT TM
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- Emory Phelps
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1 TM Features the only bovine pericardium aortic root surgery system
2 THE REPLICATES THE NATIVE SINUS, NATURALLY 2
3 TM LIVANOVA S INNOVATIVE IS DESIGNED TO: Provide a reproducible and easy solution for better patients results Take advantage of the Mitroflow proven hemodynamic and clinical results for better patients outcomes Replicate the native sinus, reducing stress on the coronary anastomoses Encourage natural formation of systolic vortex with sinus design NATURAL BLOOD FLOW 3
4 TM THE SYSTEM CONSISTS OF: The Mitroflow Valsalva Conduit, which provides: A graft specially designed to be coupled directly in the operating room with the Mitroflow/Crown PRT valve, minimizing all the risks associated with the device manipulation during assembly and implantation, while avoiding increases in procedural time A cuff to securely wrap around the Mitroflow/Crown PRT valvesewing ring, avoiding the insertion of delicate sutures for the conduit-valve assembly Commissure orientation alignment guide lines, ensuring consistent positioning of the Mitroflow/Crown PRT valve within the conduit Replicated sinus of Valsalva 1, reducing stress on the coronary anastomoses A sealed graft with no pre-clotting requirements A graft impregnated with minimally cross-linked gelatin for faster healing, encouraging a secure neo-intimal attachment with reduced inflammatory response The Mitroflow /Crown PRT TM Aortic Pericardial Heart Valve, which provides: Excellent valve hemodynamics 2,3,4 Proven durability 5,6,7 The Mitroflow Valsalva Conduit should be immersed in sterile saline for no longer than 5 minutes prior to implantation to improve its handling qualities. Align the valve commissure posts with the orientation guides on the conduit cuff. Insert the valve into the conduit. After the two green retaining threads are cut, the unfolding ring slides off the graft and pulls the conduit cuff up over the valve. Pull the suture with the blue knot until the conduit cuff folds down over the sewing ring of the valve, then tie and trim the suture. 4
5 TM In over 30 years of successful implants, the Mitroflow valve has consistently demonstrated excellent hemodynamic performance, ease of implant and proven durability. Thanks to its unique design, Mitroflow/Crown PRT offers surgeons the option, based on anatomy, of supra-annular or intra-annular valve placement with very small annuli. MITROFLOW/CROWN PRT* FEATURES: Single pericardial sheet Wide leaflet opening for improved hemodynamics Uniform mechanical behavior Optimized leaflet match Fatigue resistant Reduced risk of leaflet prolapse and dehiscense All valves are tested for functionality Cross-stitch Pattern Cylindrical leaflet opening Evenly distributed stress on the commissures Forces at the valve post minimized during cardiac cycle Knit Polyester Fabric Biocompatible Allows smooth contact between the pericardium and tissue No exposed knots Reduced microturbulence Soft Silicone Sewing Ring Insert Facilitates suturing Reduces needle friction Conforms well to the annulus Tungsten impregnated for radiopacity Acetal Homopolymeric Stent Creep resistant Couples maximum flow area with structural strength Reduced risk of valve regurgitation * Crown PRT is an evolution of the Mitroflow DL valve. The two design changes are the addition of three visible markers on the sewing cuff and the addition of three radiographic markers on the sewing ring. 5
6 TM TECHNICAL TIPS The conduit is always 5 mm larger than the valve graft. 8 Example: 21 mm Mitroflow/Crown PRT valve fits a 26 mm Valsalva Conduit Commissure Orientation Alignment Guide Holder Conduit Cuff Unfolding Ring Use the standard Mitroflow/Crown PRT Valve Sizers. Size the annulus before suture placement. Compatible valve sizes with the Mitroflow Valsalva Conduit: 21 mm - 27 mm. Always wet the graft before cauterizing. Wings of the Unfolding Ring Refer to the Instructions for Use provided with the Mitroflow Valsalva Conduit for detailed information, warnings, precautions and possible adverse effects. Conduit Purse String Suture on Conduit Cuff Handle Reusable Base MITROFLOW/CROWN PRT AND ORDERING INFORMATION (The Mitroflow/Crown PRT Aortic Valve and Mitroflow Valsalva Conduit are sold separately. Be sure to order both products.) Size Crown PRT Valve to Couple [mm] Crown PRT Catalog Number Size Mitroflow Valve to Couple [mm] Mitroflow Catalog Number Valsalva Conduit Catalog Number Graft Inner Diameter [mm] Graft Minimum Length [mm] 21 CNA21 21 DLA21 or LXA21 MVC CNA23 23 DLA23 or LXA23 MVC CNA25 25 DLA25 or LXA25 MVC CNA27 27 DLA27 or LXA27 MVC Accessories Mitroflow Valsalva Conduit Base* * Base must be cleaned and sterilized before each use. ICV1225 6
7 References 1. Hisada, et al. - The Sinus of Valsalva Relieves Abnormal Stress on Aortic Valve Leaflets by Facilitating Smooth Closure. - J Thorac Cardiovasc Surg. 2008;136: e1 2. Asch FM, et. al. - Mitroflow Aortic Bioprosthesis 5-Year Follow-Up: North American Prospective Multicenter Study. - Ann Thorac Surg. 2012;94: Jamieson W.R.E., et al. - Hemodynamic Performance of Mitroflow Aortic Pericardial Bioprosthesis Optimizing Management for the Small Aortic Annulus. - Thorac Cardiovasc Surg. 2010;58: Bleiziffer S., et al. - Hemodynamic Characterization of the Sorin Mitroflow Pericardial Bioprosthesis at Rest and Exercise. - J Heart Valve Dis. 2009; 18: The ISTHMUS Investigators. - The Italian study on the Mitroflow postoperative results (ISTHMUS): A 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis. - Eur J Cardiothorac Surg. 2011;39: Yankah C., Pasic M., Musci M., Stein J., Detschades C., Siniawski H., Hetzer R. - Aortic valve replacement with the Mitroflow Pericardial Bioprosthesis: Durability results up to 21 years. - J Thorac Cardiovasc Surg. 2008;136: Yankah, C. - Mitroflow pericardial aortic bioprosthesis in patients younger than 60 years. - J Thorac Cardiovasc Surg. 2010;140:e Maselli D., et al. - Sinotubular Junction Size Affects Aortic Root Geometry and Aortic Valve Function in the Aortic Valve Reimplantation Procedure: An In Vitro Study Using the Valsalva Graft. - Ann Thorac Surg. 2007;84:
8 FDA 0713 RE /B Sorin Group Italia Srl A wholly-owned subsidiary of LivaNova PLC Via Crescentino Saluggia (VC) Italia Tel Fax info.cardiacsurgery@livanova.com Manufactured by: Sorin Group Italia S.r.l. A wholly-owned subsidiary of LivaNova PLC For LivaNova Canada Corp. (outside EU) 5005 North Fraser Way Burnaby B.C. V5J 5M1 Canada Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects LivaNova all rights reserved.
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