Alert Indications, Safety, and Warnings

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.

Download product brochure
Mosaic heart valve, quarter bottom view
Alert Indications, Safety, and Warnings

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.

Lifetime patient management wheel visual for Mosaic bioprosthesis

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.

View details

Advanced tissue fixation

  1. Leaflets float at net-zero pressure
  2. Roots are pressurized at 40 mm Hg with glutaraldehyde
Valve tissue fixation design illustration

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
See more

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.

Illustration of asymmetrical design of Mosaic bioprosthesis shown from the top, side, and within the heart

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.

Learn more

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

Radiopaque Sapien device deployed inside the Mosaic mitral bioprosthesis

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.
Find out more
Cinch implant system attached Mosaic bioprosthesis showing open and shut

Product specifications and ordering information

Mosaic Mitral Valve, Model 310

Outlined illustration of Mosaic mitral valve model 310 with sizing callouts on white background

Order
number

Valve size
(stent O.D.‡)
(± 0.5 mm)

Orifice
diameter
(stent I.D.)
(± 0.5 mm)

Suture ring
diameter
(± 1 mm)

Valve height
(± 0.5 mm)

 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

Outlined illustration of the Mosaic aortic valve model 305 with sizing callouts on white background

Order
number

Valve size
(stent O.D.‡)
(± 0.5 mm)

Orifice diameter
(stent I.D.)
(± 0.5 mm)

Suture ring
diameter
(± 1 mm)

Valve
height
(± 0.5 mm)

Aortic
protrusion
(± 0.5 mm)

 

(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

Outlined illustration of the Mosaic Ultra aortic valve model 305 with sizing callouts on white background

Order
number

Valve size
(stent O.D.‡)
(± 0.5 mm)

Orifice
diameter
(stent I.D.)
(± 0.5 mm)

Suture ring
diameter
(± 1 mm)

Valve height
(± 0.5 mm)

Aortic
protrusion
(± 0.5 mm)

 

(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

Contact information

LifeLine Cardiovascular
Technical Support

877-526-7890

Send us an email

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.