Mechanical valves and conduits

Medtronic Open Pivot™ mechanical heart valve

Mechanical valves and conduits

Medtronic Open Pivot™ mechanical heart valve

The Medtronic Open Pivot™ heart valve is a low profile bileaflet valve indicated for the replacement of native or prosthetic aortic or mitral valves.

Ordering information
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Indications, Safety, and Warnings

Description

With the Medtronic Open Pivot™ valve, there are no orifice recesses or cavities — unlike other bileaflet valves — where potential thrombus may form.1,2 Cavity pivot valves have an area where stasis could occur.

With no cavities for blood to slow or pool, the valve design minimizes flow disruption and turbulence in the pivot area during both forward and retrograde flow.1,3–5

Features

Open Pivot™ design leads to excellent hemodynamics and reduced hemolysis

By design, continuous washing of the pivot in both open and closed positions provides gentle treatment of red blood cells and reduced hemolysis.6,7

Unique axis of suspension in leaflet design

The Open Pivot™ valve is designed so that a greater portion of the leaflet is distal to the axis of suspension, allowing leaflets to respond to the patient’s blood flow. The result is exceptionally efficient leaflet movement responsive to physiological demands and excellent hydrodynamic performance.8

This diagram shows an additional angle of the Medtronic Open Pivot™ axis of suspension.

Open Pivot™

Leaflets rest on the hinge.

This diagram shows the Medtronic Open Pivot™ and its axis of suspension.

Cavity pivot

Leaflets rest in hinge cavities and require vigorous mechanical sweeping and high-velocity flushing.

Single-plane orifice design for implantability

  • Allows for improved valve seating and implant regardless of suture technique
  • Minimal sub-annular exposure reduces orifice ring stress9,10
  • Made of solid pyrolytic carbon with a strengthening band of thin titanium that provides large orifice-to-annulus ratios while retaining structural integrity

Unique leaflet action — a remarkably quiet valve

In two one-year postoperative studies, only 18.8% of Medtronic Open Pivot™ valve patients were aware of their valve sound, compared to 78% of cavity pivot valve patients.11,12

The Medtronic Open Pivot™ AP 360 circle is for use interventional cardiology procedures.

Medtronic Open Pivot™ AP360™

Supra-annular valve with flanged cuff configuration for improved flexibility, needle penetration, and conformability.

The Medtronic Open Pivot™ standard valve is used in cardiac surgery.

Medtronic Open Pivot™ standard

Intra-annular valve with generous, compliant cuff for exceptional implantability.

The Medtronic Open Pivot™ valve is used to treat cardiovascular patients.

Medtronic Open Pivot™

Intra-annular aortic valved graft (AVG)

Ordering information

Medtronic Open Pivot™ standard aortic heart valve

Standard intra-annular

Standard aortic diameters diagram
Item number Valve size
(mm)		 Tissue annulus diameter (B)
(mm)		 Orifice inner diameter (A)
(mm)
500FA19 19 19.2 14.8
500FA21 21 21.2 16.8
500FA23 23 23.2 18.8
500FA25 25 25.2 20.8
500FA27 27 27.2 22.8
500FA29 29 29.2 24.8
500FA31† 31 31.2 26.8

Medtronic Open Pivot™ standard mitral heart valve

Standard intra-annular

Standard mitral diameters diagram
Item number Valve size
(mm)		 Tissue annulus diameter (B)
(mm)		 Orifice inner diameter (A) (mm)
500DM19† 19 19.2 14.8
500DM21† 21 21.2 16.8
500DM23† 23 23.2 18.8
500DM25 25 25.2 20.8
500DM27 27 27.2 22.8
500DM29 29 29.2 24.8
500DM31 31 31.2 26.8
500DM33 33 33.2 26.8

Medtronic Open Pivot™ AP360™ aortic heart valve

AP/AP360 supra-annular

AP360 aortic diameters diagram
Item number Valve size
(mm)		 Tissue annulus diameter (B)
(mm)		 Orifice inner diameter (A) (mm)
505DA16 16 16.2 14.8
505DA18 18 18.2 16.8
505DA20 20 20.2 18.8
505DA22 22 22.2 20.8
505DA24 24 24.2 22.8
505DA26 26 26.2 24.8
505DA28† 28 28.2 26.8

Medtronic Open Pivot™ AP360™ mitral heart valve

AP/AP360 supra-annular

AP360 mitral diameters diagram
Item number Valve size
(mm)		 Tissue annulus diameter (B)
(mm)		 Orifice inner diameter (A) (mm)
505DM16† 16 16.2 14.8
505DM18† 18 18.2 16.8
505DM20† 20 20.2 18.8
505DM22 22 22.2 20.8
505DM24 24 24.2 22.8
505DM26 26 26.2 24.8
505DM28 28 28.2 26.8

Medtronic Open Pivot™ accessories

Item number Description
576 Open Pivot™ sizer set
578 AP360 sizers
569 Bendable handle

Medtronic Open Pivot™ AVG

Intra-annular, aortic valved graft

Item number Valve size (mm)
502AG21 21
502AG23 23
502AG25 25
502AG27 27
502AG29 29
502AG31† 31
502AG33† 33

Similar products

† Model not currently available for sale in the United States.

  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. 1999;22(11):754–63.
  2. Emery RW, Petersen RJ, Kersten TE, et al. The initial United States experience with ATS mechanical cardiac valve prosthesis. Heart Surg Forum. 2001;4(4):346–353.
  3. Emery RW, Van Nooten GJ, Tesar PJ. The initial experience with the ATS mechanical cardiac valve prosthesis. Ann Thorac Surg. 2003;75(2):444–452.
  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. Dumont K, Vierendeels J, Kaminsky R, van Nooten G, Verdonck P, Bluestein D. Comparison of the hemodynamic and thrombogenic performance of two bileaflet mechanical heart valves using a CFD/FSI model. J Biomech Eng. 2007;129(4):558–565.

  1. 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.
  2. Krian A. Clinical results of a large series of ATS valve implants. Krian A, Matloff JM, Nicoloff DM. Advancing the Technology of Bioleaflet Mechanical Heart Valves. Springer Verlag; 1998:53–71.
  3. Feng Z, Umezu M, Fujimoto T, Tsukahara T, Nurishi M, Kawaguchi D. In vitro hydrodynamic characteristics among three bileaflet valves in the mitral position. Artif Organs. 2000; 24(5):346–354.
  4. Nakamura Y, Nakano K, Tagusari O, et al. An alternative option for elderly patients with a small aortic annulus: the 16 mm ATS valve. J Heart Valve Dis. 2009;18(6):691–697.
  5. Kobayashi Y, Fukushima Y, Hayase T, Kojima K, Endo G. Clinical outcome of aortic valve replacement with 16-mm ATS-advanced performance valve for small aortic annulus. Ann Thorac Surg. 2010;89(4):1195–1199.
  6. Sezai A, Shiono M, Orime Y, et al. Evaluation of valve sound and its effects on ATS prosthetic valves in patients’ quality of life. Ann Thorac Surg. 2000;69(2):507–512.
  7. Umeda T. An evaluation study on the quietness of the ATS valve. Ann Thorac Cardiovasc Surg. 2007;13(3):172–177.