Valve Aortic Accessories Trifecta Valve Sizer Set Handles Global Headquarters Cardiovascular Division St. Jude Medical Coordination Center BVBA

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1 Trifecta Valve

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3 Whe the Goal Is Superior Hemodyamics 1 The Valve Is Trifecta. Itroducig the ext-geeratio pericardial tissue heart valve ad perfect complemet to the lie of tissue valves from St. Jude Medical that icludes Epic ad Biocor. The Trifecta valve is a steted tissue heart valve with i vivo sigle-digit mea gradiets across all valve sizes. 1 The uique valve desig icludes pericardial tissue leaflets attached to the exterior of the valve stet to ope more fully ad efficietly to perform like a atural heart valve. For more tha 30 years, St. Jude Medical has demostrated a commitmet to cardiac surgery, offerig patiets the gold stadard i mechaical heart valve performace ad tissue valve durability, ad applies this market-leadig expertise to the developmet of the Trifecta valve.

4 Whe the Goal Is Hemodyamics. Created exclusively for the aortic positio, the Trifecta valve delivers sigificatly larger EOAs, resultig i sigle-digit pressure gradiets. The Trifecta valve is desiged to mimic the flow of a atural, healthy heart valve ad offers excellet hemodyamic performace, which may provide patiets with a improved quality of life. I vivo sigle-digit mea gradiets averaged across all valve sizes at six moths. 1 exterally mouted tissue allows for leaflets to ope more fully, efficietly performig more like a atural heart valve. Large EOAs across all valve sizes result i decreased risk of patiet-prosthesis mismatch at six moths. 1

5 Whe the Goal Is Dur ability. With more tha 30 years of market experiece, the Trifecta valve was desiged for log-term durability ad performace. The result is a desig that has demostrated excellet i vitro wear testig Pericardial covered stet for tissue-to-tissue cotact reducig the risk of abrasio ad structural valve deterioratio. 1 2 Elimiatio of tackig suture at top of commissure reduces risk of tearig. 3 Proper leaflet shapig ad coaptatio are achieved through proprietary tissue leaflet fixatio. 2 4 Leaflets from a sigle pericardial sheet, exterally mouted, optimize coaptatio ad maximize flow. Fatigue-resistat, high-stregth titaium stet desiged to reduce stress o leaflets durig cardiac cycle. 1 Lix AC Techology Lix AC Techology is a pateted proprietary valve treatmet that has bee demostrated i aimal studies to reduce calcificatio i both porcie ad bovie pericardial tissue. *2-8 *There is o cliical data curretly available that evaluates the log-term impact of aticalcificatio tissue treatmet i humas.

6 Whe the Goal Is Implatability. The Trifecta valve offers superior hemodyamic performace 1 with the implatability of a steted valve, accommodatig a surgeo s existig implatatio techique. Cotoured silicoe isert withi a uique polyester cuff is desiged to coform to the shape of the ative aulus for proper seatig ad to reduce the risk of PV leak. 1 Trifecta valve sizers are optimized for true-to-size valve selectio. Cylidrical itra-aular ed Replica ed Efficiet 2 x 10-secod rise. Aortic valve holder improves visibility ad cuff access for suturig. Both the flexible ad rigid valve holder hadles provide quick, click-i hadle attachmet ad removal to stabilize the valve ad miimize the risk of useatig.

7 Our Commitmet to Cardiac Surgery. The St. Jude Medical commitmet to cardiac surgery cotiues to grow through our legacy of marketleadig heart valves. Addig to our portfolio of highly regarded mechaical heart valves ad tissue heart valves Epic ad Biocor, the Trifecta valve offers sigificatly larger EOAs tha ay steted bioprosthetic heart valve o the market. With outstadig performace i all three key areas of hemodyamics, durability ad implatability, the Trifecta valve demostrates our passio of puttig more cotrol ito the hads of physicias to offer patiets a improved quality of life.

8 Orderig Iformatio Aortic Model /Reorder Number Tissue Aulus Diameter (mm) Cuff Outer Diameter (mm) Total Height (mm) TF-19A TF-21A TF-23A TF-25A TF-27A TF-29A Accessories Model Number Trifecta Valve Sizer Set TF2000 Hadles UT2000 Descriptio Aortic Protrusio (mm) Autoclavable tray with cover, flexible holder hadle (UT2000) ad six double-eded aortic sizers (19 mm 29 mm) with a valve replica ed ad a cylidrical aular sizig ed. Flexible holder hadle. Made with Nitiol to provide flexibility durig implatatio of the Trifecta valve. (The UT2000 is also icluded i the Trifecta Valve Sizer Set.) UT2000-R Rigid holder hadle. Made of stailess steel to provide more rigidity tha the UT2000. May be used i place of the UT2000. EX2000-R Rigid extesio hadle. Made of stailess steel to provide additioal legth whe used with a holder hadle. Refereces 1. St. Jude Medical, Ic., Trifecta 400 Late Patiet Year Report at six-moth follow-up, Jauary Data o File, St. Jude Medical. 3. Frater RWM, Seifter E, Liao K, et al. Advaces i aticalcific ad atidegeerative treatmet of heart valve bioprostheses. Edited by Gabbay S, ad Wheatley D. First editio. Silet Parters, Ic. 1997;8: Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility ad calcificatio of bioprosthetic heart valves. Society for Biomaterials, Sixth World Biomaterials Cogress Trasactio, 2000; Vyavahare N, Hirsch D, Lerer E, et al. Prevetio of bioprosthetic heart valve calcificatio by ethaol preicubatio. Circ. 1997;95: Vyavahare N, Hirsch D, Lerer E, et al. Prevetio of calcificatio of glutaraldehyde crossliked porcie aortic cusps by ethaol preicubatio. J Biomed Mater Res. 1998;40: Vyavahare N, Lloyd Joes P, Hirsch D, et al. Prevetio of glutaraldehyde fixed bioprosthetic heart valve calcificatio by alcohol pretreatmet: Further mechaistic studies. J Heart Disease. 2000;9: She M, Kara-Mostefa A, Carpetier A, et al. Effect of ethaol ad ether i the prevetio of calcificatio of bioprostheses. A Thorac Surg. 2001;71:S TISSUE MECHANICAL REPAIR SURGICAL ABLATION Global Headquarters Oe St. Jude Medical Drive St. Paul, Miesota USA Fax Cardiovascular Divisio 177 East Couty Road B St. Paul, Miesota USA Fax St. Jude Medical Coordiatio Ceter BVBA The Corporate Village Aveue Da ViciIaa 11 Box F1 B-1935 Zavetem Belgium Fax SJMprofessioal.com Product refereced is approved for CE Mark. Not available for sale i the U.S. Devices depicted may ot be available i all coutries. Check with your St. Jude Medical represetative for product availability i your coutry. Uless otherwise oted, idicates a registered or uregistered trademark or service mark owed by, or licesed to, St. Jude Medical, Ic. or oe of its subsidiaries. Trifecta, Lix, Biocor, Epic, ST. JUDE MEDICAL, the ie-squares symbol ad MORE CONTROL. LESS RISK. are registered ad uregistered trademarks ad service marks of St. Jude Medical, Ic. ad its related compaies St. Jude Medical, Ic. All rights reserved. Prited i Belgium. Item GMCSD125EN