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Medtronic Open Pivot Mechanical Valve

Heart Valve Disease

Medtronic Open Pivot™ heart valve

Overview

The Medtronic Open Pivot™ heart valve contains two half discs—called leaflets—which tilt to open and close with each heartbeat, regulating the flow of blood. The valve is surrounded by a polyester fabric ring, which the surgeon uses to attach the valve to the heart tissues.

Key Features

Unique Design with Low Risk of Blood Clots
The Medtronic Open Pivot mechanical heart valve has a unique design that eliminates shallow recesses in the hinge area where blood clots may form.(1,2,3)

Excellent Blood Flow
Studies have shown that a continuous, gentle flow of blood results in low levels of clotting and helps prevent damage to blood cells.(2,4,5,6)

Durable and Long Lasting
Medtronic Open Pivot mechanical valves are made of carbon with a titanium strengthening band for outstanding durability. An Open Pivot mechanical valve usually lasts throughout a patient’s lifetime and doesn’t need replacement.

Remarkably Quiet
Medtronic Open Pivot mechanical valves are made of carbon with a titanium strengthening band for outstanding durability. An Open Pivot mechanical valve usually lasts throughout a patient’s lifetime and doesn’t need replacement.

Placement

The device is not shown actual size. Other sizes may be available. Valve shown is a size 26 mm.

Size

The device is not shown actual size. Other sizes may be available.

Inner Diam. 0.9765" (24.8 mm)
Outer Diam. 1.415" (35.9 mm)

Medtronic Open Pivot™ Heart Valves

Indications: Medtronic Open Pivot™ Heart Valves are used to replace your heart's natural valve when it has become diseased or weakened by age. It can also be used to replace your prosthetic valve when it is no longer functioning properly. (A prosthetic valve is a replacement valve made of human, animal, or artificial materials.)

Contraindications: These valves should not be used in patients who cannot tolerate long-term anticoagulation therapy.

Adverse Events: Valve replacement procedures may include, but are not limited to the following risks:

  • Abnormal heart beat (dysrhythmia)
  • Death
  • Failure of the valve to open and close properly
  • Infection
  • Damage to red blood cells (hemolysis)
  • Hemorrhage
  • Blood leaking across the valve or between the valve and the patient's tissue (transvalvular leak/paravalvular leak)
  • Blood clot formation on or around the valve; these blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
  • Valve dysfunction
    This list is not inclusive of all risks. Talk to your physician regarding more information about valve replacement surgery.
    CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

References

1

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.

2

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.

3

Van Nooten GJ, Caes F, Francois K, et al. Fifteen years’ single-center experience with the ATS bileaflet valve. J Heart Valve Dis. 2009;18(4):445-452.

4

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.

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

Shiono M, Sezai Y, Sezai A, et al. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Ann Thorac Cardiovasc Surg. 1996; 2(1):51-58.

7

Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Ann Thorac Surg. 2000;69:507-512.


Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.