Symetis / Boston Scientific: ACURATE neo™ & ACURATE TF DS - (CE)

Transcatheter aortic valve devices

The ACURATE neo Aortic Valve with Transfemoral and Transapical Delivery Systems, is a self-expanding, supra-annular valve, offering an intuitive procedure, predictable release, stable positioning, and has demonstrated excellent clinical outcomes.

ACURATE neo™ & ACURATE TF DS Introduction

The Symetis transfemoral TAVI system consists of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transfemoral Delivery System. The self-positioning bioprosthesis is composed of a porcine pericardial tissue valve sewn into a self-expanding nitinol stent covered with an anti-leak porcine pericardial skirt. Its transfemoral delivery system is designed for a simple 3-step deployment and stable positioning within the native annulus. The product is compatible with the 15F Terumo Solopath or 18F Cook sheaths. The product is available in three sizes (S, M, L) to treat patients with aortic annulus diameters from 21mm to 27mm.

The rollout of ACURATE neo will be modeled on the successful commercialization of Symetis's transapical system, ACURATE TA, which has witnessed a remarkably rapid uptake in core European markets. Clinical trials include the use of ACURATE Neo™ AS Aortic Bioprosthesis for implantation using the ACURATE neoTM AS TF Transfemoral Delivery System in patients with severe aortic stenosis.

ACURATE neo Aortic Bioprosthesis

ACURATE neo (annotation): figure 86

Figure 86. ACURATE neo (annotation)

 
1 - Stabalisation arches
2 - Self-expanding Nitinol stent
3 - Upper crown
4 - Supra-annular valve
5 - Innter and outer anti-PVL skirts
6 - Waist
7 - Lower crown

Product information

ACURATE neo dimension: figure 86

Figure 87. ACURATE neo (dimension)

ACURATE neo™ Aortic Bioprosthesis (native annulus diameter)

ACURATE neo™ Aortic Bioprosthesis (native annulus diameter): figure 109

Figure 109. ACURATE neo™ Aortic Bioprosthesis (native annulus diameter)

ACURATE neo

Native annulus diameter

Small

21-23 mm

Medium

23-25 mm

Large

25-27 mm


Native annulus perimeter

Native annulus area

66-72 mm

346-415 mm2

72-79 mm

415-491 mm2

79-85 mm

491-573 mm2

Symetis ACURATE neo™ animation

Symetis ACURATE neo/TF
General characteristics

Design

Self-expanding

Frame

Nitinol

Leaflets

Porcine pericardium

Valve size

S, M, L

[figure=89 chapter=3]Delivery system diameter[/figure]

18 Fr

Implantation access

Transfemoral [video=22 chapter=3]

Repositionable

Partially

Retrievable after being fully deployed

No

Additional cuff to reduce AR

Yes

Anchoring mechanism

By design

Tactile feedback during deployment

Yes

Large stent cell design

Yes

Markers to facilitate deployment

Yes

Motorised delivery system

No

Anticalcification technology

Yes


CE mark status: Yes - 2014

Special features:

  • Compatible with 15 Fr balloon-expandable SoloPath sheath
  • Self-seating, self-sealing design for optimal positioning and sealing and reduced PV leak
  • Unique top-down deployment for stable and controlled valve release movie 28 [video=28 chapter=3].

Product advantages:

  • Intuitive procedure: flexible transfemoral and low-profile transapical delivery systems and self-aligning valve
  • Predictable release: safe two-step, top-down deployment with stable hemodynamics
  • Stable Positioning: effective self-fixationp and self-sealing
  • Superior outcomes: very low gradients and new pacemarker rates

Angiogram implantation:

  • ACURATE neo/TF angiogram implantation [video=102 chapter=4]
  • ACURATE neo/TF phantom model implantation [video=114 chapter=4]
  • ACURATE neo 3D rotational angiogram [video=113 chapter=4]

Find out more

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