Medtronic: CoreValve®, CoreValve® Evolut™ and CoreValve® Evolut™ R

Medtronic

The Medtronic CoreValve™, CoreValve® Evolut™ and CoreValve® Evolut™ R system. The CoreValve Platform was designed specifically to meet the clinical needs of your TAVI patients.

Table of content

CoreValve® Introduction

Over the last 10 years, the majority of surgically implanted aortic valves have been bioprosthetic. With a life expectancy of 10-20 years, the number of patients requiring redo surgery for failed bioprostheses is expected to increase. CoreValve and CoreValve Evolut provide options for heart teams who treat patients at high operative risk for redo surgery.

The Medtronic CoreValve™ system consists of 3 components: the transcatheter aortic valve (bioprosthesis), the delivery catheter system (catheter), and the compression loading system (CLS).

Figure 9. Medtronic CoreValve Transcatheter Aortic Valve

Figure 9. Medtronic CoreValve Transcatheter Aortic Valve

 

Figure 9. Medtronic CoreValve Transcatheter Aortic Valve

Figure 9. Medtronic CoreValve Transcatheter Aortic Valve

 

Figure 10. Medtronic CoreValve Transcatheter Aortic Valve Dimensions

Figure 10. Medtronic CoreValve Transcatheter Aortic Valve Dimensions

 

Figure 11. Medtronic CoreValve Transcatheter Aortic Valve native annulus diameter

Figure 11. Medtronic CoreValve Transcatheter Aortic Valve native annulus diameter

CoreValve

Native annulus diameter

26 mm

20-23 mm

29 mm

23-27 mm

31 mm

26-29 mm


 

General characteristics:

Design

Self-expanding

Frame

Nitinol

Leaflets

Porcine pericardium

Valve size (mm)

26 mm, 29 mm, 31 mm

Delivery system diameter - [figure=12 chapter=3]1[/figure] / [figure=13 chapter=3]2[/figure]

18 Fr

Implantation access

Transfemoral[video=2 chapter=3], Subclavian, Direct Aortic

Repositionable

Partially

Retrievable after being fully deployed

No

Additional cuff to reduce AR

No

Anchoring mechanism

No

Tactile feedback during deployment

No

Large stent cell design

Yes

Markers to facilitate deployment

Yes

Motorised delivery system

No

Anticalcification technology

Yes


CE mark status: Yes - 16/05/2007

 
Special features:

  • Preserves circularity and optimises leaflet coaptation at the level of valve function with supra-annular valve design
  • Approved for use in degenerative surgical bioprostheses
  • CoreValve angiogram implantation [Link=4.6.7.1]
  • CoreValve phantom model implantation [video=123 chapter=4]
  • CoreValve 3D rotational angiogram [video=111 chapter=4]

CAUTION: Implantation of the Medtronic CoreValve™ system should be performed only by physicians who have received Medtronic CoreValve™ training.

 
Medtronic CoreValve™ system animation

Medtronic CoreValve™ system animation

 

CoreValve® Evolut™ Introduction

Medtronic CoreValve Evolut transcatheter aortic valve

Medtronic CoreValve Evolut transcatheter aortic valve

Medtronic CoreValve Evolut

Native annulus diameter

23 mm

18-20 mm


 

Figure 25. Medtronic CoreValve Evolut transcatheter aortic valve dimensions

Figure 25. Medtronic CoreValve Evolut transcatheter aortic valve dimensions

 

General characteristic:

Design

Self-expanding

Frame

Nitinol

Leaflets

Porcine pericardium

Valve size (mm)

23 mm

Delivery system diameter - [figure=12 chapter=3]1[/figure] / [figure=13 chapter=3]2[/figure]

18 Fr

Implantation access

Transfemoral, Subclavian, Direct Aortic

Repositionable

Partially

Retrievable after being fully deployed

No

Additional cuff to reduce AR

No

Anchoring mechanism

No

Tactile feedback during deployment

No

Large stent cell design

Yes

Markers to facilitate deployment

Yes

Motorised delivery system

No

Anticalcification technology

Yes


CE mark status: Yes - 26/09/2012

 
Special features:

  • Customises anatomical fit via a tailored height and shape
  • Conforms to the anatomy and promotes sealing with optimised cover index and radial force
  • Preserves circularity and optimises leaflet coaptation at the level of valve function with supra-annular valve design
  • Approved for use in degenerative surgical bioprostheses
     

CoreValve® Evolut™ R Introduction

The new recapturable, self-expanding CoreValve™ Evolut™ R System for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis patients who are at high or extreme risk for surgery. The CoreValve™ Evolut™ R recapturable and repositionable heart valve improves positioning accuracy and control during deployment.

Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Designed to treat patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body, the CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 75,000 patients in 60 countries.

CoreValve Evolut R TAVI system has received CE approval to expand the indication to include patients who are at high or greater risk for surgical aortic valve replacement OR are ≥75 years of age and at intermediate risk for surgical AVR (Society of Thoracic Surgeons operative risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team).

Figure 110. Medtronic CoreValve Evolut R transcatheter aortic valve

Figure 110. Medtronic CoreValve Evolut R transcatheter aortic valve

Medtronic CoreValve Evolut R

Native annulus diameter

23mm

18-20mm

26mm*

20-23mm

29mm*

23-26mm

3Xmm*

26-30mm


 

Figure 111. Medtronic CoreValve Evolut R transcatheter aortic valve

Figure 111. Medtronic CoreValve Evolut R transcatheter aortic valve

 
General characteristics:

Design

Self-expanding

Frame

Nitinol

Leaflets

Porcine pericardium

Valve size (mm)

23 mm (CE), 26 mm*, 29 mm*, 3X mm*

[figure=112 chapter=3]Delivery system diameter[/figure]

14 Fr equivalent

Implantation access

Transfemoral, Subclavian, Direct Aortic

Repositionable

Yes

Retrievable after being fully deployed

No

Additional cuff to reduce AR

No

Anchoring mechanism

No

Tactile feedback during deployment

No

Large stent cell design

Yes

Markers to facilitate deployment

Yes

Motorised delivery system

No

Anticalcification technology

Yes


CE mark status: Yes - 03/09/2014 for 23 mm

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