26 Oct 2017
Boston Scientific: ACURATE neo™ Transfemoral and ACURATE neo™ Transapical Aortic Valve Systems
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.
Boston Scientific Corporation has finished the acquisition of Symetis SA. Boston Scientific now sells the ACURATE neo™ Transfemoral and ACURATE neo™ Transapical Aortic Valve Systems. The LOTUS™ Valve System is a registered trademark of Boston Scientific.
ACURATE neo™ and ACURATE TF™ Delivery System Introduction
The Boston Scientific 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 2-step deployment and stable positioning within the native annulus. The product is compatible with the 18F LOTUS Introducer Sheath. 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 has witnessed a remarkably rapid uptake in core European markets. Clinical trials include the SAVI-TF 1000 patients’ registry1, the comparative, propensity-matched MORENA study by Husser et al.2 comparing it to SAPIEN 3 and the propensity-matched comparative study published by Mauri et al. comparing its performance in small annuli3, as well as two ongoing randomized trials (SCOPE I and SCOPE II) comparing against SAPIEN 3 and the Corevalve Evolut valve family, respectively.
References:
- Eurointervention 2017; Jaa-273 2017, doi: 10.4244/EIJ-D-17.00628
- Husser, O. et al.; JACC: Cardiovascular Interventions. 10. 2078-2087. 10.1016/j.jcin.2017.06.026.
- Mauri, V. et al.: Circ Cardiovasc Interv. 2017;10:e005013
ACURATE neo™ Aortic Bioprosthesis
Figure 86. ACURATE neo™
1 - STABILISATION ARCHES
Axial self-alignment of the bioprosthesis
2 - SELF-EXPANDING NITINOL STENT
Anatomic conformability to the native annular shape
3 - UPPER CROWN
Supra-annular anchoring minimises risk of coronary occlusion
4 - SUPRA-ANNULAR VALVE
Low gradient
Porcine pericardial leaflets
BioFix™ anticalcification process
5 - INNER AND OUTER ANTI-PVL SKIRTS
Sealing against paravalvular leak
6 - WAIST
Captures calcified leaflets
7 - LOWER CROWN
Low risk of conduction system interference
Product information
Figure 87. ACURATE neo™
ACURATE neo™ Aortic Bioprosthesis (native annulus diameter)
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 |
ACURATE TA™ animation
ACURATE neo™ animation
General characteristics
Design | Self-expanding |
Frame | Nitinol |
Leaflets | Porcine pericardium |
Valve size | S, M, L |
Delivery system diameter - 1 (Figure 89) | 18 Fr |
Implantation access | Transfemoral (Movie 22) |
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 18 Fr LOTUS Introducer 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).
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-fixation and self-sealing
- Superior outcomes: very low gradients and new pacemaker rates
