MITROFLOW VALSALVA CONDUIT TM

Features the only bovine pericardiumaortic root surgery system

THE MITROFLOW VALSALVA CONDUIT REPLICATES THE NATIVE SINUS,

NATURALLY

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LIVANOVA’S INNOVATIVE MITROFLOW VALSALVA CONDUIT

IS DESIGNED TO:Provide a reproducible and easy solution for better patients results

Take advantage of the Mitroflow proven hemodynamicand 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

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TMMITROFLOW VALSALVA CONDUIT

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The Mitroflow Valsalva Conduit, which provides:

• A graft specially designed to be coupled directly inthe operating room with the Mitroflow/Crown PRTvalve, minimizing all the risks associated with the devicemanipulation during assembly and implantation, whileavoiding increases in procedural time

• A cuff to securely wrap around the Mitroflow/Crown PRTvalvesewing ring, avoiding the insertion of delicate suturesfor the conduit-valve assembly

• Commissure orientation alignment guide lines,ensuring consistent positioning of theMitroflow/Crown PRT valve within the conduit

• Replicated sinus of Valsalva1, reducing stress on thecoronary anastomoses

• A sealed graft with no pre-clotting requirements

• A graft impregnated with minimally cross-linked gelatinfor faster healing, encouraging a secure neo-intimalattachment with reduced inflammatory response

The Mitroflow®/Crown PRTTM

Aortic Pericardial Heart Valve, which provides:

• Excellent valve hemodynamics2,3,4

• 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.

THE MITROFLOW VALSALVA CONDUIT SYSTEM CONSISTS OF:

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TMMITROFLOW VALSALVA CONDUIT

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

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.

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TMMITROFLOW VALSALVA CONDUIT

* 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 additionof three radiographic markers on the sewing ring.

Conduit

Reusable Base

Wings of the Unfolding Ring

Purse String Suture on Conduit Cuff

Handle

Unfolding Ring

Conduit CuffHolderCommissure OrientationAlignment Guide

TECHNICAL TIPS• The conduit is always 5 mm larger than the valve graft.8

Example: 21 mm Mitroflow/Crown PRT valve fits a 26 mmValsalva Conduit

• 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.

• Refer to the Instructions for Use provided with theMitroflow Valsalva Conduit for detailed information,warnings, precautions and possible adverse effects.

MITROFLOW/CROWN PRT AND MITROFLOW VALSALVA CONDUIT 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 MVC026 26 100

23 CNA23 23 DLA23 or LXA23 MVC028 28 100

25 CNA25 25 DLA25 or LXA25 MVC030 30 100

27 CNA27 27 DLA27 or LXA27 MVC032 32 100

AccessoriesMitroflow Valsalva Conduit Base* ICV1225

* Base must be cleaned and sterilized before each use.

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TMMITROFLOW VALSALVA CONDUIT

References1. Hisada, et al. - The Sinus of Valsalva Relieves Abnormal Stress on Aortic Valve Leaflets by Facilitating Smooth Closure. - J Thorac

Cardiovasc Surg. 2008;136:1528–1535.e1

2. Asch FM, et. al. - Mitroflow Aortic Bioprosthesis 5-Year Follow-Up: North American Prospective Multicenter Study. - Ann Thorac Surg. 2012;94:1198-1203

3. Jamieson W.R.E., et al. - Hemodynamic Performance of Mitroflow Aortic Pericardial Bioprosthesis – Optimizing Management for theSmall Aortic Annulus. - Thorac Cardiovasc Surg. 2010;58:69–75

4. Bleiziffer S., et al. - Hemodynamic Characterization of the Sorin Mitroflow Pericardial Bioprosthesis at Rest and Exercise. - J HeartValve Dis. 2009; 18:95–100

5. The ISTHMUS Investigators. - The Italian study on the Mitroflow postoperative results (ISTHMUS): A 20-year, multicentre evaluation ofMitroflow pericardial bioprosthesis. - Eur J Cardiothorac Surg. 2011;39:18–26

6. Yankah C., Pasic M., Musci M., Stein J., Detschades C., Siniawski H., Hetzer R. - Aortic valve replacement with the Mitroflow PericardialBioprosthesis: Durability results up to 21 years. - J Thorac Cardiovasc Surg. 2008;136:688–696

7. Yankah, C. - Mitroflow pericardial aortic bioprosthesis in patients younger than 60 years. - J Thorac Cardiovasc Surg. 2010;140:e83–4

8. 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;84:1214–1218

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Sorin Group Italia SrlA wholly-owned subsidiary of LivaNova PLCVia Crescentino13040 Saluggia (VC) ItaliaTel +39 0161 487472Fax +39 0161 487316info.cardiacsurgery@livanova.com

www.livanova.com

Manufactured by:Sorin Group Italia S.r.l.A wholly-owned subsidiary of LivaNova PLCFor LivaNova Canada Corp. (outside EU) 5005 North Fraser WayBurnaby B.C. V5J 5M1 Canada

0713

RE0

2101

73/B

FDA

Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects.

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