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 bioprosthesis on white background
Alert Indications, Safety, and Warnings

Overview

Design Expertise

The Mosaic bioprosthesis — based on more than 30 years of Medtronic tissue-valve design expertise — is an excellent choice for surgeons looking for long-lasting durability, exceptional performance and implantability for aortic, mitral, and MICS procedures.

Product Details

Undeniably Durable

Published clinical experience demonstrates impressive long-term performance in all age groups. Additional factors that may contribute to durability are:

  • Proprietary AOA™ anti-calcification tissue treatment that mitigates calcification and protects the tissue*
  • Next-generation flexible polymer stent that allows for absorption of stress produced during the cardiac cycle
  • Physiologic Fixation process that minimizes the stress applied to the leaflets during fixation*
AOA anti-calcification tissue treatment illustration

AOA™ anti-calcification tissue treatment

Excellent  Clinical Outcomes

  • Aortic: 81% freedom from explant due to SVD at 17 years1
  • Mitral: 80% freedom from explant due to SVD at 16 years1

 

Ease of Implant

Our innovative Cinch™ implant system further capitalizes on the valve’s flexible stent to facilitate valve implantation, particularly through a tight sinotubular space. It also:

  • Improves overall visualization
  • Has stent posts that deflect to allow for easier knot tying near the posts in aortic replacements
  • Helps prevent suture looping
  • Facilitates minimally invasive procedures
  • Protects tissue from inadvertent damage
Mosaic's Cinch implant system on blue gradient background

Advanced Tissue Fixation

Our exclusive Physiologic Fixation* process mitigates biomechanical failures and promotes 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
  
  1. Leaflets float at net zero pressure
  2. Roots are pressured at 40 mm Hg with glutaraldehyde
Valve tissue fixation design illustration

Suitable for Future Interventions

Valve dimensions and geometry facilitate future TAV-in-SAV replacements. This includes:

  • Radiopaque stent post eyelets, which provide visible coaxial markers during TAV-in-SAV procedures
  • MR conditional, nonmetallic frame mitigates risk of corrosion between SAV and TAV stent materials
  • Interior-mounted leaflets mitigate potential risk of coronary obstruction
Mosaic heart valve, quarter top view

Product Specifications and Ordering Information

Mosaic Aortic Valve, Model 305

Mosaic Model 305 configuration with sizing detail illustration

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 Mitral Valve, Model 310

Mosaic Model 310 configuration with sizing detail illustration

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)

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 Ultra Aortic Valve, Model 305

Mosaic Ultra Model 305 configuration with sizing detail illustration

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

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)
Download Brochure

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
*

No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients.

†

Equivalent to annulus diameter.

Reference

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.