Stented Tissue Valve Assembly Process/media/pro/products/sh/s-z/trifecta... · Leaflet Attachment The pericardial leaflet strip is sutured to the tissue-covered stent while on a size-specific

Stented Tissue Valve Assembly Process

TrifectaTM

Valve

The St. Jude Medical Trifecta Stented Tissue Valve Assembly Process

1

The Trifecta valve is the latest pericardial tissue valve specifically designed for the aortic position. It consists of bovine pericardial tissue mounted on a polyester- and porcine-covered titanium stent.

The valve assembly process incorporates key design features and quality measures to build a valve designed to maximize hemodynamic performance and optimize valve durability.

2

Stent Manufacture

The Trifecta valve begins with a fatigue-resistant, high-strength titanium stent. The stent was designed and is fabricated to achieve maximum durability and improved hemodynamic performance. The stent is laser cut and polished to precise measurements. It is radiopaque for visualization.

Stent posts are covered with polyester fabric to enhance wear characteristics.

1Valve Assembly

Process

n Laser cut for precise dimensionsn Mechanically polished and electropolished to achieve a blemish-free surfacen Multiple computerized inspection steps to verify precise dimensions and

surface qualityn Stent posts covered with polyester fabric

Key QuAlity MeAsures

Electropolished Fabric-covered Stent PostsLaser Cut

3

Fabric Stent Cover

Polyester fabric sheets are sewn into a tube and then formed into a stent shape.

Polyester Tube

Stent Shape Form

2Valve Assembly

Process

n Polyester fabric is ordered to exact specifications n Tube sewn on the bias to enhance fit over stent and minimize bulkiness of fabricn Each step in the process is inspected

Key QuAlity MeAsures

4

Fabric Stent Cover

A silicone ring is encapsulated in the sewing cuff to improve implantability characteristics. It is contoured to conform to patient anatomy.

The fabric serves as an anchor point for porcine and pericardial tissue attachment.

3Valve Assembly

Process

Silicone Ring

Fabric-covered Stent

n Fabric-covered titanium stent designed to enhance the wear characteristics of the leaflets

n All assembly methods are performed to ensure maximum flow areaKey QuAlity MeAsures

5

Tissue Stent Covering

Porcine pericardial tissue covers the stent, excluding the sewing cuff area, and reduces the amount of fabric exposed to blood flow. Porcine pericardium is thinner than bovine pericardium and provides the tissue-to-tissue contact with the bovine leaflets. The tissue-to-tissue contact is designed to minimize the risk of leaflet abrasion and structural valve deterioration.1-3 Only St. Jude Medical incorporates this tissue-to-tissue interface in the construction of tissue valves.

4Valve Assembly

Process

n Porcine pericardial tissue is selected based on tissue qualityn Precise thickness measurements are taken in multiple areas/places

and must meet manufacturing specificationsn Each assembly is inspected for stitching accuracy and placementn Stitching and tissue overlap occur on the outside of posts to ensure

maximum internal flow area

Key QuAlity MeAsures

Trim pericardium Attach pericardial tissue Completed tissue covering

n Fabric-covered titanium stent designed to enhance the wear characteristics of the leaflets

n All assembly methods are performed to ensure maximum flow area

6

Bovine Pericardium Leaflets 5Valve Assembly

Process

Bovine pericardium is received in whole sacs from

government-inspected abattoirs.

Bovine pericardium must meet proprietary thickness measurements.

Valve leaflets are formed from a single strip of pericardium and matched to the appropriate size valve.

n Bovine pericardium is hand-selected and inspectedn Bovine pericardium is measured to meet precise thickness specificationsn Each pericardial strip is inspected for fiber orientation and must meet

strict specificationsn Each piece of pericardium is cut to precise dimensions

Key QuAlity MeAsures

7

Leaflet Attachment

The pericardial leaflet strip is sutured to the tissue-covered stent while on a

size-specific mandrel.

Leaflets are attached to the stent post with a unique suturing pattern that allows for full leaflet opening.

6Valve Assembly

Process

n Controlled extension of the tissue a few millimeters beyond the stent postn No stitch at the top of the leaflet commissuren Unique contour of leaflets is controlled during attachment phase

Key QuAlity MeAsures

8

Tissue Fixation

Mounted tissue valves are put through proprietary, low-pressure fixation processes.

7Valve Assembly

Process

n Each valve is inspected to precise visual specificationsKey QuAlity MeAsure

9

Functional Testing

Each valve is rigorously tested to ensure proper valve function.

8Valve Assembly

Process

n Valves are 100% functionally testedn Valves are 100% visually inspected in a pulsatile flow environment

and must meet strict specifications

Key QuAlity MeAsures

10

Valve Holder Attachment

Upon successful completion of all quality inspections and functional testing, the valve is mounted to a valve holder. The valve holder is specifically designed to allow maximum visualization and stabilization to ease implantation.

9Valve Assembly

Process

The valve holder is constructed from a polyphenylsulfone material to accommodate a click-in attachment of the

handle. It has a white quick-release button.

n The polyphenylsulfone valve holder improves visibility and cuff access for suturing

Key QuAlity MeAsure

11

Sterilization

Valves are chemically sterilized by exposure to a St. Jude Medical-developed sterilant solution. The Trifecta valve is treated with the patented Linx™ AC anticalcification treatment during the sterilization process.

10Valve Assembly

Process

n Chemical concentrations are guaranteed by HPLC analysisn All sterilization lots are tested for sterility and endotoxin levels n Ethanol concentrations during Linx anticalcification treatment verified

by HPLC analysisn Final product jars are torqued and vacuum tested for hermetic

seal verification

Key QuAlity MeAsures

linx AC technology*

In studies on bovine pericardial tissue, Linx AC technology reduces calcification.4-6

*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

extracts lipids9

reducesfree

aldehydes7,8

Minimizesuptake of

cholesterol10

Proprietary anticalcification technology

stabilizes leaflet collagen10

12

references

1. McGonagle-Wolff K, Schoen F. Morphologic findings in explanted Mitroflow pericardial bioprosthetic valves. Am J Cardiol. 1992;70(2):263-4. 2. Butany J, Yu W, Silver MD, et al. Morphologic findings in explanted Hancock II porcine bioprostheses. J Heart Valve Dis. 1999;8(1):4-15. 3. Bottio T, Valente M, Rizzoli G, et al. Commissural dehiscence: A rare and peculiar cause of porcine valve structural deterioration.

J Thorac Cardiovasc Surg. 2006;132(5):1017-22. 4. St. Jude Medical. Data on File. 5. Vyavahare N, Jones PL, Hirsch D, et al. Prevention of glutaraldehyde-fixed bioprosthetic heart valve calcification by alcohol pretreatment:

Further mechanistic studies. J Heart Valve Dis. 2000;9(4):561-6. 6. Shen M, Kara-Mostefa A, Carpentier A, et al. Effect of ethanol and ether in the prevention of calcification of bioprostheses. Ann Thorac Surg.

2001;71(5 Suppl):S413-6. 7. Frater RWM, Seifter E, Liao K, et al. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. Edited by Gabbay S,

and Wheatley D. First Edition, Silent Partners, Inc. 1997;8:105-13. 8. Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and Calcification of Bioprosthetic Heart Valves. Society for Biomaterials, Sixth World Biomaterials

Congress Transaction, 2000;13534. 9. Vyavahare N, Hirsch D, Lerner E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Efficacy and mechanisms.

Circulation. 1997;95(2):479-88.10. Vyavahare N, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation.

J Biomed Mater Res. 1998;40(4):577-85.

rx Only

Brief summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, perforation, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.

Product referenced is approved for CE Mark.

Trifecta, Linx, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved.

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