SimuForm™ Annuloplasty Ring for surgical valve repair

The SimuForm ring is elevating mitral repair — its flexible anterior part accommodates anterior motion, while the semi-rigid posterior part enables remodeling.

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Overview

Hybrid shape

  • The mitral valve annulus changes shape in the cardiac cycle. SimuForm rings do not have a fixed saddle shape; instead, they change shape in systole and diastole.
  • SimuForm rings are available in a full size range of 24–40 mm.

Product details

SimuForm annuloplasty ring shown with systole saddle shape

Elevated saddle shape in Systole

  • Flexible anterior portion accommodates natural motion.
  • The saddle has been shown to increase leaflet coaptation and curvature,1-3 and reduce leaflet and chordal stresses.4-6
SimuForm annuloplasty ring shown with diastole "O" shape

Planar "O" Shape in Diastole

SimuForm rings are not fixed into a saddle shape — they are flattened to an "O" shape to accommodate diastolic filing dynamics.

Clinical evidence

Results from a single-center, retrospective analysis show that the SimuForm platform7:

  • Demonstrates excellent survival rates — 99.7% ± 0.2% at one year and 90.8% ± 4.6% at five years.
  • Shows high repair success rate with very low rates of reoperation at midterm follow-up with conventional and minimally invasive access.
  • Effectively reduces the risk of recurrent mitral valve regurgitation.
  • Reduces the risk of Systolic Anterior Motion (SAM) — zero cases reported after mitral repair at midterm follow-up.

Cumulative incidence of reoperation

Graph showing very low rates of reoperation with SimuForm at midterm follow up

Degree of mitral valve regurgitation

Graph showing very low rates of recurrent mitral regurgitation with SimuForm at midterm follow-up

Watch Professor Lange's presentation on the SimuForm platform's clinical performance at the EACTS 2021 annual meeting.

Key risks of mitral valve repair include recurrent regurgitation, stenosis, and ring dehiscence.

Accessory enhancements

Blue handle-to-holder connection site at top of SimuForm holder

Low-profile, open holder

Place sutures along the entire flexible ring while fully accessing anatomy.

 

Two cut towers on top of the SimuForm holder – one septal, one lateral

Clearly marked cut towers 

Easily identify the two cut towers on the holder, which enables quick release of the ring.

Blue handle-to-holder connection site at top of the holder, connected with the handle

Stable handle-to-holder connection

Allows for low-force, single-cut release, and remains securely attached during suturing.

Green chordal reference line across the horizontal length of SimuForm

Visual chordal reference line

Provides visual reference of annular plane when performing chordal repair.

Specifications and ordering information

SimuForm ring product information

Illustration of SimuForm ring with callouts

A: Inner ring diameter

B: Outer ring diameter

C: Inner stiffener diameter

Size
(mm)

Product
codes

“A”
(mm)

“B”
(mm)

Orifice area
(mm2)

Stiffener assembly
inner diameter (mm)

24

7800RR24

23.1

31.0

290

24.6

26

7800RR26

25.0

32.9

340

26.5

28

7800RR28

26.9

34.9

390

28.5

30

7800RR30

28.9

36.8

460

30.4

32

7800RR32

30.7

38.7

480

32.3

34

7800RR34

32.7

40.6

560

34.2

36

7800RR36

34.6

42.6

640

36.2

38

7800RR38

36.6

44.5

730

38.1

40

7800RR40

38.5

46.4

810

40.0

 

SimuForm ring ordering information

SimuForm accessory tray on white background

Order number

Components and accessories

T7800P

SimuForm accessory tray

7800PS

Set of 9 SimuForm polysulfone sizers

7686

Annuloplasty handle (216 mm length)

7686L

Annuloplasty handle (254 mm length)
7686XL Annuloplasty handle (373 mm length)

Contact information

LifeLine Cardiovascular
Technical Support

877-526-7890

Medtronic Mitral Academy

Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.

References

1

Jensen MO, Jensen H, Levine RA, et al. Saddle-shaped Mitral Valve Annuloplasty Rings Improve Leaflet Coaptation Geometry. J Thorac Cardiovasc Surg. September 2011;142(3):697-703.

2

Ryan LP, Jackson BM, Hamamoto H, et al. The Influence of Annuloplasty Ring Geometry on Mitral Leaflet Curvature. Ann Thorac Surg. September 2008;86(3):749-760.

3

Vergnat M, Jackson BM, Cheung AT, et al. Saddle-shape Annuloplasty Increases Mitral Leaflet Coaptation After Repair for Flail Posterior Leaflet. Ann Thorac Surg. September 2011;92(3):797-803.

4

Jimenez JH, Liou SW, Padala M, et al. A Saddle-Shaped Annulus Reduces Systolic Strain on the Central Region of the Mitral Valve Anterior Leaflet. J Thorac Cardiovasc Surg. December 2007;134(6):1562-1568.

5

Padala M, Hutchison RA, Croft LR, et al. Saddle shape of the mitral annulus reduces systolic strains on the P2 segment of the posterior mitral leaflet. Ann Thorac Surg. November 2009;88(5):1499-1504.

6

Pierce EL, Bloodworth CH, Imai A, et al. Mitral Annuloplasty Ring Flexibility Preferentially Reduces Posterior Suture Forces. J Biomech. June 25, 2018;75:58-66.

7

Sideris K, Burri M, Bordne J, et al. Repair of Mitral Valves with Severe Annular Dilatation and Abundant Leaflet Tissue Using a Prosthetic Ring with a Large Anterior-Posterior Diameter. J Clin Med. March 19, 2022;11(6):1709.