Mosaic Mitral Bioprosthesis
for heart valve replacement
The Mosaic™ mitral bioprosthesis allows leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue.
Overview
Built for a life. Time tested.
The Mosaic mitral bioprosthesis — based on more than 50 years of Medtronic tissue-valve design expertise — is a great option for surgeons seeking unsurpassed long-term durability, excellent hemodynamics, and a smooth implanting experience.
Product features
Published clinical experience demonstrates industry-leading long-term performance.
Features that may contribute to durability are:
- Proprietary AOA™ anti-calcification tissue treatment with clinical use in more than half a million patients for over 30 years.†
- High-performance stent that allows for absorption of stress produced during the cardiac cycle.
- 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 valve.
- Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue.
Watch the video to learn more about Mosaic mitral's unsurpassed durability.
AOA anti-calcification treatment
The Medtronic-patented AOA tissue treatment mitigates calcification and protects the tissue.†
- AOA covalently bonds with free aldehydes and washes lipids away.
- Large AOA molecules slow diffusion of calcium into tissue matrix.
Physiologic tissue fixation
- Leaflets float at net-zero pressure.
- Roots are pressurized at 40 mmHg with glutaraldehyde.
Long-term outcomes of mitral valve replacements
Mosaic mitral versus Perimount™*
This retrospective, single-center study compared the long-term outcomes of Mosaic porcine mitral valves 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
- 13.2% for CE Perimount or Magna mitral
On average, the time before reoperation for SVD was 4.3 years longer with Mosaic porcine valves than Edwards pericardial valves.
Time to reoperation for SVD
The Mosaic mitral bioprosthesis 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 bioprosthesis instructions for use, hemodynamic results at one year2:
| Mosaic mitral 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 EOA (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) |
Native design offers one wider leaflet.
The asymmetrical design of Mosaic offers one wider leaflet spaced at 135° with an interstrut distance of 18.4 mm in size 29, for example.
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.
Sapien™* device deployed inside Mosaic mitral
Implantability
The Cinch™ implant system capitalizes on the flexible stent to facilitate valve implantation, particularly through tight patient anatomy:
- Aids minimally invasive procedures
- Helps prevent suture looping
- Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus
- Assists implantation with clear markings for proper orientation
- Offers smooth needle penetration and suture placement with a fluffy, conformable cuff
- Provides improved visibility for proper implant orientation, which may reduce the risk of complications
Ordering information
Mosaic mitral valve, Model 310
| Order |
Valve size |
Orifice |
Suture ring |
Valve height |
Ventricular protrusion (± 0.5 mm) |
|---|---|---|---|---|---|
|
|
(A) |
(B) |
(C) |
(D) |
(E) |
| 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
| Order 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
*
™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.
‡
Equivalent to annulus diameter.
References
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.
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.
4
Data on file at Medtronic. Report #D00807486_A, July 28, 2022.