Mosaic and Mosaic Ultra Bioprostheses for heart valve replacement
The Mosaic™ bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock™ II valve.
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Overview
The Mosaic bioprosthesis — based on more than 30 years of Medtronic tissue-valve design expertise — is a great option for surgeons seeking exceptional long-term durability, excellent hemodynamics, and a smooth implanting experience.
Product details
Undeniably durable
Published clinical experience demonstrates impressive long-term performance, including in patients under 60 years. Additional factors that may contribute to durability are:
- Proprietary AOA™ anti-calcification tissue treatment that mitigates calcification and protects the tissue.†
- 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.
† 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.
Advanced tissue fixation
- Leaflets float at net-zero pressure
- Roots are pressurized at 40 mm Hg with glutaraldehyde
Excellent clinical outcomes
In a prospective, multicenter, long-term follow-up observational study of 1,029 patients, the following outcomes were reported:
- Mitral: 79.7% freedom from explant due to SVD at 16 years1
- Aortic: 81.2% freedom from explant due to SVD at 17 years1
Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet related), leak (transvalvular or paravalvular), myocardial infarction nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, other) thromboembolism, valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death.
Hemodynamics at one year2
As reported in the Mosaic bioprostheis Instructions for Use.
| 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) |
Designed to accommodate ventricular flow
The Mosaic valve reflects the asymmetry of the native porcine valve. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow.
Mosaic 29
The asymmetrical design of Mosaic offers one wider leaflet spaced at 135° with an interstrut distance of 18.4 mm.
Viewed from the inflow aspect, the widest intercommissural space of the Mosaic lies between the green suture marker and the first commissure post in the counterclockwise direction. Orienting the bioprosthesis in the annulus such that the green suture marker is directed approximately toward the right fibrous trigone should position the widest intercommissural space appropriately.
Suitable for future interventions
Valve dimensions and geometry facilitate future ViV procedures.
- Radiopaque stent post eyelets on the Mosaic 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
Image source: Mitral valve-in-valve app.
Ease of implant
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.
Product specifications and 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 |
Mosaic Aortic Valve, Model 305
| Order |
Valve size |
Orifice diameter |
Suture ring |
Valve |
Aortic |
|---|---|---|---|---|---|
|
|
(A) |
(B) |
(C) |
(D) |
(E) |
| 305C219 |
19 |
17.5 |
25.0 |
13.5 |
11.0 |
| 305C221 |
21 |
18.5 |
27.0 |
15.0 |
12.0 |
| 305C223 |
23 |
20.5 |
30.0 |
16.0 |
13.5 |
| 305C225 |
25 |
22.5 |
33.0 |
17.5 |
15.0 |
| 305C227 |
27 |
24.0 |
36.0 |
18.5 |
15.5 |
| 305C229 |
29 |
26.0 |
39.0 |
20.0 |
16.0 |
Mosaic Ultra™ Aortic Valve, Model 305
| Order |
Valve size |
Orifice |
Suture ring |
Valve height |
Aortic |
|---|---|---|---|---|---|
|
|
(A) |
(B) |
(C) |
(D) |
(E) |
| 305U219 |
19 |
17.5 |
24.0 |
13.5 |
11.0 |
| 305U221 |
21 |
18.5 |
26.0 |
15.0 |
12.0 |
| 305U223 |
23 |
20.5 |
28.0 |
16.0 |
13.5 |
| 305U225 |
25 |
22.5 |
30.0 |
17.5 |
15.0 |
| 305U227 |
27 |
24.0 |
32.0 |
18.5 |
15.5 |
| 305U229 |
29 |
26.0 |
34.0 |
20.0 |
16.0 |
‡ Equivalent to annulus diameter.
Accessories
| Order number |
Description |
|---|---|
| T7308C |
Mosaic aortic sizers tray |
| T7615MSM |
Tray, accessory, Mosaic mitral |
| T7308U |
Tray, accessory, Mosaic Ultra aortic |
| 7308U |
Mosaic Ultra aortic sizers |
| 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 |
| 7308C |
Mosaic aortic sizer set |
| 7310 |
Mosaic mitral obturator set (no handles, no tray) |
Additional resources
Medtronic
Mitral Academy
Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.
Register here™*Third-party brands are trademarks of their respective owners.
References
1
Rieß FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Ann Thorac Surg. March 2018;105(3):763-769.
2
Mosaic Porcine Bioprosthesis. Instructions for Use. Medtronic, Inc. 2018. 1220016001 Rev. 1C.
3
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. August 2020;110(2):508-515.