Tissue valves and conduits

Mosaic™ mitral bioprosthesis

Tissue valves and conduits

Mosaic™ mitral bioprosthesis

The Mosaic™ mitral bioprosthesis is a next-generation native porcine valve for mitral valve replacement.

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Indications, Safety, and Warnings

Features

Built for a life. Time tested.

Based on more than 50 years of Medtronic tissue-valve design expertise, the Mosaic™ mitral valve is a great option for surgeons seeking unsurpassed long-term durability, excellent hemodynamics, and a smooth implanting experience.1–3

Durability

Published clinical experience demonstrates industry-leading long-term performance.1,3

Features that may contribute to the Mosaic™ mitral valve’s durability are:

  • Proprietary amino oleic acid (AOA™) anti-calcification tissue treatment with clinical use across a suite of devices in more than half a million patients for over 30 years†
  • High-performance stent that allows for absorption of stress produced during the cardiac cycle4
  • Physiologic fixation, our advanced tissue fixation process, to mitigate biomechanical failures and promote long-term valve durability by: 
    • Improving preservation of valve structure and leaflet function, allowing it to function similar to a native valve5,6
    • Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue5,6

Learn more about the Mosaic™ mitral valve’s unsurpassed durability. (03:27)

AOA™ anti-calcification treatment

The Medtronic-patented AOA™ tissue treatment is designed to reduce calcification and protect the tissue.†

  • AOA™ covalently bonds with free aldehydes and washes lipids away.7–9
  • Large AOA™ molecules slow diffusion of calcium into tissue matrix.

Learn more about mitigating calcification with AOA™ tissue treatment. (03:31)

Physiologic tissue fixation

  1. Leaflets float at net-zero pressure.
  2. Roots are pressurized at 40 mmHg with glutaraldehyde.
This is an illustration of the tissue fixation design with callouts.

Hemodynamics

The Mosaic™ mitral valve was designed to allow for maximum blood flow. The creation of the valve — from the porcine leaflets and valve geometry (specifically stent height) to how the tissue is mounted in the frame — affects how optimally the blood flows in diastole, and how well the leaflets coapt in systole. 

As reported in the Mosaic™ mitral valve instructions for use, hemodynamic results at one year2:

 

Mosaic™ mitral valve size3 25 27 29 31 33
Mean gradient (mm)
(n = )		 5.7 ± 1.7 (41) 4.6 ± 2.1 (98) 4.4 ± 1.8 (123) 3.7 ± 1.4 (50) 3.4 ± 1.8 (8)
Mean effective orifice area (cm2)
(n = )		 1.6 ± 0.4 (35) 1.7 ± 0.5 (90) 1.8 ± 0.5 (114) 1.7 ± 0.5 (43) 1.9 ± 0.5 (6)

 

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Geometry and reintervention

Designed to accommodate ventricular flow

The Mosaic™ mitral valve reflects the asymmetry of the native porcine valve, providing one wider leaflet spaced at 135 degrees. This largest leaflet of the Mosaic™ mitral valve is intended to align with the patient’s anterior mitral leaflet to accommodate ventricular flow.

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This illustration shows the asymmetrical design of the Mosaic™ bioprosthesis with one wider leaflet spaced at 135 degrees with an interstrut distance of 18.4 mm.

Suitable for future interventions

Valve dimensions and geometry facilitate future valve-in-valve (ViV) procedures.

  • Radiopaque stent post eyelets on the Mosaic™ mitral valve provide visible markers to help correctly position the transcatheter valve during ViV procedures.
  • MR Conditional, nonmetallic frame mitigates risk of corrosion between surgical valve and transcatheter valve stent materials.
This image shows a radiopaque SAPIEN™* device deployed inside the Mosaic™ mitral bioprosthesis.

 

SAPIEN™* device deployed inside Mosaic™ mitral valve

Implantability

The Cinch™ implant system capitalizes on the flexible stent and offers different features to facilitate valve implantation:

  • Aids minimally invasive procedures through small incisions11
  • Helps prevent suture looping11
  • Designed to protect tissue from inadvertent damage and prevent entanglements with the sub-valvular apparatus
  • Assists implantation with clear marking for proper orientation2
  • Offers smooth needle penetration and suture placement with a pliable, conformable cuff12
View implantability details (open in new window)
The Cinch™ implant system for the Mosaic™ bioprosthesis capitalizes on the flexible stent to facilitate valve implantation, particularly through tight patient anatomy.

Clinical evidence

Long-term outcomes of mitral valve replacements

Mosaic™ mitral valve versus Carpentier-Edwards bovine pericardial mitral valves

This retrospective study compared the long-term outcomes of the Mosaic™ porcine mitral valve to Carpentier-Edwards bovine pericardial mitral valves in 940 patients.1

Cumulative incidence of reoperation at 15 years (p < 0.001):

  • 7.9% for Mosaic™ mitral valve
  • 13.2% for CE Perimount™* or Magna™* mitral valve

Survival at 15 years (p = 0.67):

  • 24.0% for Mosaic™ mitral valve
  • 16.5% for CE Perimount™* or Magna™* mitral valve

Mosaic™ mitral valve

CE Perimount™*/Magna™* mitral valve

On average, the time before reoperation for structural valve deterioration (SVD) was 4.3 years longer with the Mosaic™ porcine valve than Carpentier-Edwards pericardial valves.

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Time to reoperation for SVD‡

This bar chart compares the Mosaic™ mitral bioprosthesis to the Edwards pericardial valve in time to reoperation for SVD.

Mosaic™ mitral valve versus Epic™* mitral valve

This retrospective, single-center study analyzed long-term outcomes of 335 patients undergoing isolated mitral valve replacement.13​

Freedom from reintervention at 10 years (p = 0.1):​

  • 79.1% for Mosaic™ mitral​ valve
  • 62.2% for Epic™* mitral valve

Freedom from definite (confirmed on reoperation) SVD (p = 1.00):

  • 91.7% for Mosaic™ mitral valve group
  • 89.4% for Epic™* mitral valve group

Mosaic™ mitral valve

Epic™* mitral valve

Cumulative incidence of reintervention with death as competing risk​

View this graph to see the results of a study which analyzed long-term outcomes of 335 patients undergoing isolated mitral valve replacement using the Mosaic™ mitral valve versus the Epic™ mitral valve.

“At 10 years after mitral valve replacement, the cumulative incidence of reintervention was twice as high in the Epic™* group.”§

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Ordering information

Mosaic™ mitral valve, Model 310

 

A: Valve size
B: Orifice diameter
C: Suture ring diameter
D: Valve height
E: Ventricular protrusion

 

Item number A: Valve size (stent OD◊)
(± 0.5 mm)		 B: Orifice diameter (stent ID)
(± 0.5 mm)		 C: Suture ring diameter
(± 1 mm)		 D: Valve height
(± 0.5 mm)		 E: Ventricular protrusion
(± 0.5 mm)
310C25 25 22.5 33.0 18.0 13.5
310C27 27 24.0 35.0 19.0 14.0
310C29 29 26.0 38.0 20.5 15.5
310C31 31 28.0 41.0 22.0 17.0
310C33 33 30.0 43.0 23.0 17.5

Accessories

Item number Description
T7615MSM Tray, accessory, Mosaic™ mitral
7639 Handle (234 mm length) pliant, without locknut to be used with Mosaic™ or Mosaic Ultra™ prostheses
7639XL Handle (368 mm length) pliant, without locknut to be used with Mosaic™ or Mosaic Ultra™ prostheses
7310 Mosaic™ mitral obturator set (no handles, no tray)

Resources

Similar products

TM* Third-party brands are trademarks of their respective owners.

† The benefits of AOA™ tissue treatment have been demonstrated through animal testing. No direct clinical evaluation of the benefits of AOA™ treatment in humans has been conducted.

‡ SVD was defined, according to STS, as dysfunction or deterioration involving the operated valve, exclusive of infection or thrombosis, as determined by reoperation, autopsy, or clinical investigation. Mean follow-up times were significantly different (Mosaic™: 7.0 ± 4.8 versus Edwards: 6.0 ± 3.9, p = 0.002).

§ 95% CI 32.7%–36.1% in the Epic™* group; 16.2%–18.9% in the Mosaic™ group.

◊ Equivalent to annulus diameter.

  1. Beute T, Goehler M, Parker J, et al. Long-term outcomes of Mosaic versus Perimount mitral replacements: 17-year follow up of 940 implants. Ann Thorac Surg. 2020;110(2):508–515. doi: 10.1016/j.athoracsur.2019.10.075.
  2. Mosaic™ porcine bioprosthesis instructions for use. Medtronic, Inc. 1220016001 rev. 1C; 2018.
  3. Rieß FC, Fradet G, Lavoie A, Legget M. Long-term outcomes of Mosaic bioprosthesis. Ann Thorac Surg. 2018;105(3):763–769. doi: 10.1016/j.athoracsur.2017.09.053.
  4. Reis R, Hancock WD, Yarbrough JW, Glancy DL, Morrow AG. The flexible stent. A new concept in the fabrication of tissue heart valve prostheses. J Thorac Cardiovasc Surg. 1971;62(5):683–689. passim.
  5. Vesely I. Analysis of the Medtronic Intact bioprosthetic valve. Effects of “zero-pressure“ fixation. J Thorac Cardiovasc Surg. 1991;101(1):90–99.
  6. Mayne ASD, Christie GW, Smaill BH, Hunter PJ, Barratt-Boyes BG. An assessment of the mechanical properties of leaflets from four second-generation porcine bioprostheses with biaxial testing techniques. J Thorac Cardiovasc Surg. 1989;98(2):170–180.
  7. Girardot MN, Girardot JM, Schoen FJ. Development of the AOA process as antimineralization treatment for bioprosthetic heart valves. Trans Soc Biomat. 1993;53(2):207–215; discussion 216.
  8. Girardot MN, Torrianni M, Girardot JM. Effect of AOA on glutaraldehyde-fixed bioprosthetic heart valve cusps and walls: binding and calcification studies. Int J Artif Organs. 1994;17(2):76–82. 
  9. Gott JP, Pan-Chih, Dorsey JM, et al. Calcification of porcine valves: a successful new method of antimineralization. Ann Thorac Surg. 1992;53(2):207–215. doi: 10.1016/0003-4975(92)91321-y.
  10. Based on internal testing report D00807486_A. Information shown on this page represents measurement for size 29 mm Mosaic™ mitral valve. July 28, 2022.
  11. Takagi K, Arinaga K, Takaseya T, et al. Hemodynamic and clinical performance of the 25-mm Medtronic Mosaic porcine bioprosthesis in the mitral position. J Artif Organs. 2021;25(1):34–41. doi: 10.1007/s10047-021-01277-1.
  12. Based on human factors engineering report, 10137288DOC rev 1A surg; 98:170–180. 1998.
  13. Tomšič A, de Weger A, van der Stoel M, Klautz RJM, Palmen M. A nationwide study on mitral valve repair vs replacement for active endocarditis. Ann Thorac Surg. 2024;117(1):120–126. doi: 10.1016/j.athoracsur.2023.08.032.