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Medtronic Open Pivot Aortic Valved Graft (AVG)

Medtronic Open Pivot Aortic Valved Graft (AVG)

The Medtronic Open Pivot™ Aortic Valved Graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability.

Summary

Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivot Aortic Valved Graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2 This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3

Excellent Hemodynamics

In-vivo studies demonstrate excellent hemodynamics.3,4,5

Easy Implantability

With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning.

Proven Graft Material

The Hemashield®* Woven Double Velour Graft is a low-porosity graft material to improve hemostasis.6,7 Excellent resorption rates facilitate healing.6 The graft material also offers exceptional handling characteristics.

Simple Valve Selection

Convenient accessories include nine white-handled, single-ended Standard Heart Valve Sizers. Each sizer handle has a clear cylindrical ring that approximates the patient’s tissue annulus size for appropriate valve selection.

*Hemashield® is a registered trademark of MAQUET Cardiovascular, LLC.


Important Safety Information

Risks: Certain complications may occur with heart valve procedures. The adverse events potentially associated with the use of mechanical heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.

Adverse events potentially associated with the use of vascular grafts include: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma.

It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death.



References

1

Kelly SGD, Verdonck PR, Vierendeels JAM, et al. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs. 1999;22:754-763.

2

Emery RW, Petersen RJ, Kersten TE, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Surgery Forum. 2001;4(4):346-353.

3

Emery RW, Krogh CC, Jones DJ, et al. Five-year follow up of the ATS mechanical heart valve. J Heart Valve Dis. 2004 Mar;13(2):231-238.

4

Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. Eur J Cardio-thorac Surg. 1996(10):660-665.

5

ATS Medical, Inc. Pre-market Approval Application – Summary of Safety and Effectiveness: 2000. Washington D.C.: U.S. Food and Drug Administration; 2000.

6

Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts: early results. J Thorac Cardiovasc Surg. 1993 Sep;106:427-433.

7

Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. J Vasc Surg. 1993 Mar;17(3):538-45.