Trifecta™ Valve with Glide™ Technology (GT)
CARDIOVASCULAR
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Trifecta™ Valve with Glide™ Technology (GT)

DESCRIPTION

The Trifecta™ GT Valve combines the best-in-class hemodynamics of the Trifecta™ Valve with ease of placement for challenging anatomies and enhanced features for future interventions, should the need arise. The Trifecta™ GT valve is designed for performance for both conventional and minimally invasive procedures.


PRODUCT HIGHLIGHTS


The Trifecta™ GT valve is designed to:

  • Provide excellent hemodynamic performance1
  • Provide excellent durability with the pericardial-covered stent for tissue-to-tissue contact to prevent the risk of abrasion2
  • Address valve calcification with Linx™ AC treatment*3-9
  • Maintain structural integrity with a high-strength, fatigue-resistant, titanium alloy stent2
  • Provide easier access to the aortic annulus specifically for inexperienced surgeons and in minimally invasive approaches

Materials List

  • Valve Leaflets: Bovine pericardium
  • Stent: Titanium (radiopaque)
  • Fabric Stent Covering: Polyester
  • Valve Sewing Cuff: Polyester
  • Tissue Stent Covering: Porcine pericardium
  • Latex-free

ORDERING INFORMATION


Reorder Number Tissue Annulus Diameter (mm) Cuff Outer Diameter (mm) Total Height (mm) Aortic Protrusion (mm)
TFGT-19A  19 24 15 12
TFGT-21A 21 26 16 13
TFGT-23A 23 28 17 13
TFGT-25A 25 31 18 14
TFGT-27A 27 33 19 15
TFGT-29A 29 35 20 16

Accessories Ordering Information

Reorder Number Description
TF2000-2  Autoclavable tray with cover, rigid holder handle (screw-in) T2002-R and six double-ended aortic sizers (19 mm–29 mm) with a valve replica end and a cylindrical annular sizing end. UT2000-R rigid holder handle (click-in) is included in TF 2000-2 set for the Trifecta valve.
T2002-R Trifecta™ GT rigid holder handle. Made of stainless steel to provide more rigidity than the T2002. May be used in place of T2002.
T2002 Trifecta™ GT flexible holder handle. Made with nitinol to provide flexibility during implantation. May be used in place of T2002-R.
EX2000-R  Rigid extension handle. Made of stainless steel to provide additional length when used with a holder handle.
EX-05  Flexible extension handle. Made of nitinol to provide additional length when used with a holder handle.
 Trifecta™ Valve with Glide™ Technology (GT)

1. Bavaria J. E., Desai, N. D., Cheung, A., Petracek, M. R., Groh, M. A., Borger, M. A., & Schaff, H .V. (2014). The St Jude Medical Trifecta aortic pericardial valve: Results from a global, multicenter, prospective clinical study. The Journal of Thoracic and Cardiovascular Surgery, 147(2), 590-7. doi: 10.1016/j.jtcvs.2012.12.087

2. Data on File. St. Jude Medical Technical Report, 90166169

3. Frater, R. W. M., Seifter, E., Liao, K., et al. (1997). Advances in anticalcific and antidegenerative treatment of heart valve bioprostheses. Edited by Gabbay S, and Wheatley D, First Edition, Silent Partners, Inc., 8, 05-13.

4. Kelly, S. J., Ogle, M. F., Caryle, W. C., et al. (2000). Biocompatibility and calcification of bioprosthetic heart valves. Society for Biomaterials, Sixth World Biomaterials Congress Transaction, 13534.

5. Vyavahare, N., Hirsch, D., Lerner, E., Baskin, J. Z., Schoen, F. J., Bianco, R. . . . Levy, R. J. (1997). Prevention of bioprosthetic heart valve calcification by ethanol preincubation: Efficacy and mechanisms. Circulation, 95(2), 479-88. http://www.ncbi.nlm.nih.gov/pubmed/9008467

6. Vyavahare, N., Hirsch, D., Lerner, E., Baskin, J. Z., Zand, R., Schoen, F. J., & Levy, R. J. (1998). Prevention of calcification of glutaraldehyde crosslinked porcine aortic cusps by ethanol preincubation: Mechanistic studies of protein structure and water-biomaterial relationships. Journal of Biomedical Materials Research. 40(4), 577-85. http://www.ncbi.nlm.nih.gov/pubmed/9599034

7. Vyavahare, N., Jones, P. L., Hirsch, D., Schoen, F. J., & Levy, R. J. (2000). Prevention of glutaraldehyde fixed bioprosthetic heart valve calcification by alcohol pretreatment: Further mechanistic studies. Journal of Heart Valve Disease. 9(4), 561-6. http://www.ncbi.nlm.nih.gov/pubmed/10947050

8. Shen, M., Kara-Mostefa, A., Chen, L., Daudon, M., Thevenin, M., Lacour, B., & Carpentier, A. (2001). Effect of ethanol and ether in the prevention of calcification of bioprostheses. The Annals of Thoracic Surgery, 71(5 Suppl), S413-6. http://www.ncbi.nlm.nih.gov/pubmed/11388238

9. Data on File. St. Jude Medical Technical Report, 871988.


Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

SJM-TRF-0116-0062

Last Updated: January 02, 2019

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