Alert Indications, Safety, and Warnings

Medtronic Open Pivot™ Aortic Valved Graft (AVG) for Aortic Valve and Ascending Aorta Replacement

The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability.

View Product Details
Length view of the Medtronic Open Pivot aortic valve graft on a white background
Alert Indications, Safety, and Warnings

Overview

Bileaflet Valve

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

Product Details

Excellent Hemodynamics

In-vivo studies demonstrate excellent hemodynamics.3-5

Easy Implantability

With no tapers or pleats, the Medtronic Open Pivot AVG 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 made with 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.

Additional Resources

Contact Information

LifeLine CardioVascular
Technical Support

877-526-7890

Send Us an Email

Medtronic
Mitral Academy

Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.

Register Here
*

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

References

1

Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Int J Artif Organs. November 1999;22(11):754-763.

2

Emery RW, Petersen RJ, Kersten TE, et al. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Surg Forum. 2001;4(4):346-352.

3

Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Five-year follow up of the ATS mechanical heart valve. J Heart Valve Dis. March 2004;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 Cardiothorac Surg. 1996;10(8):660-665.

5

Premarket Approval (PMA). U.S. Food & Drug Administration. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. Accessed April 20, 2021.

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. September 1993;106(3):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. March 1993;17(3):538-545.