Annuloplasty

SimuForm™ annuloplasty ring

<p>The SimuForm™ annuloplasty ring has a flexible segment designed to accommodate anterior motion, while the semi-rigid posterior segment enables remodeling.</p>

Features

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.
     

Elevated saddle shape in systole

  • The 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
The SimuForm™ annuloplasty ring has an elevated saddle shape in systole.

Planar “O” shape in diastole

SimuForm™ rings are not fixed into a saddle shape — they are flattened to an “O” shape designed to accommodate diastolic filling dynamics.

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

Watch Dr. Michael Chu’s case presentation using the SimuForm™ ring in endoscopic mitral repair.

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

The SimuForm™ platform demonstrates very low rates of reoperation at midterm follow-up.

Degree of mitral valve regurgitation

SimuForm™ demonstrates very low rates of recurrent mitral regurgitation at midterm follow-up.

Key risks of mitral annuloplasty include recurrent regurgitation, stenosis, and ring/band dehiscence.


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


Accessory enhancements

The SimuForm™ low-profile open holder allows suture placement along the entire ring.

Low-profile,
open holder

Place sutures along the entire semi-rigid ring while fully accessing anatomy.

Easily identify the two cut towers, which enable quick release of the SimuForm™ annuloplasty ring.

Clearly marked
cut towers

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

The SimuForm™ handle-to-holder allows for low-force, single-cut release, and remains securely attached during suturing.

Stable handle-to-holder
connection

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

The SimuForm™ visual chordal reference line provides visual reference of the annular plane when performing chordal repair.

Visual chordal
reference line

Provides visual reference of annular plane when performing chordal repair

Ordering information

A: Inner ring diameter
B: Outer ring diameter
C: Inner stiffener diameter
Item number Ring size (mm) A: Inner ring diameter (mm) B: Outer ring diameter (mm) Orifice area (mm2) C: Stiffener assembly ID (mm)
7800RR24 24 23.1 31.0 290 24.6
7800RR26 26 25.0 32.9 340 26.5
7800RR28 28 26.9 34.9 390 28.5
7800RR30 30 28.9 36.8 460 30.4
7800RR32 32 30.7 38.7 480 32.3
7800RR34 34 32.7 40.6 560 34.2
7800RR36 36 34.6 42.6 640 36.2
7800RR38 38 36.6 44.5 730 38.1
7800RR40 40 38.5 46.4 810 40.0


Components and accessories 

Item number Description
T7800P SimuForm™ accessory tray
7800PS SimuForm™ polysulfone sizer — 9 sizers
7686 Annuloplasty handle — length: 216 mm
7686L Annuloplasty handle — length: 254 mm
7686XL Annuloplasty handle — length: 373 mm

 

  1. Jensen MO, Jensen H, Levine RA, et al. Saddle-shaped mitral valve annuloplasty rings improve leaflet coaptation geometry. J Thorac Cardiovasc Surg. 2011;142(3):697–703.

  1. Ryan LP, Jackson BM, Hamamoto H, et al. The influence of annuloplasty ring geometry on mitral leaflet curvature. Ann Thorac Surg. 2008;86(3):749–760.
  2. Vergnat M, Jackson BM, Cheung AT, et al. Saddle-shape annuloplasty increases mitral leaflet coaptation after repair for flail posterior leaflet. Ann Thorac Surg. 2011;92(3):797–803.
  3. 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. 2007;134(6):1562–1568.
  4. 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. 2009;88(5):1499–1504.
  5. Pierce EL, Bloodworth CH, Imai A, et al. Mitral annuloplasty ring flexibility preferentially reduces posterior suture forces. J Biomech. 2018;75:58–66.
  6. 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. 2022;11(6):1709.