Alert Indications, Safety, and Warnings

EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR)

The Evolut™ PRO system combines exceptional valve design and advanced sealing with an excellent safety profile.

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Image showing the outer wrap of the Evolut PRO Transcatheter Aortic Valve
Alert Indications, Safety, and Warnings

Overview

Meet the Evolut PRO System

The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance.

See how the external tissue wrap on the Evolut PRO TAV performs.

   

PRODUCT DETAILS

EXCEPTIONAL DESIGN

The Evolut PRO valve features an external tissue wrap added to the proven platform design. These legacy and new design features provide the following sealing mechanisms: 

  • The external wrap increases surface contact with native anatomy, providing advanced sealing.
  • The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range.

Image of a Evolut PRO Transcatheter Aortic Valve showing how its design facilitates advanced sealing

Image of Evolut PRO Transcatheter Aortic Valve showing how the oversizing facilitates consistent radial force

THE HEMODYNAMIC ADVANTAGE OF THE EVOLUT TAVR PLATFORM

The Evolut TAVR platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients.

The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA).  Benefits of a large EOA may include:

  • Less workload for the ventricle1
  • Fewer instances of prosthesis-patient mismatch (PPM), which has been correlated to improved long-term survival2
  • A large EOA provides improved flow, less resistance, and better long-term durability3

Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs.

Topview of the Evolut R Transcatheter Aortic Valve

Control and Access

Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately.

Broadest annulus range*
More patients have access to the minimally invasive TAVR procedure because of the expanded annulus range.

Evolut PRO valves in sizes from 23mm to 34mm valves and 17 to 30 mm annulus sizes

Lowest delivery profile
The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus.

Recapture and reposition
The EnVeo PRO delivery system assists in accurate positioning of the valve. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule.

Image of the EnVeo PRO delivery system featuring accurate positioning

In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition4 for more accurate placement.

The Confida™ Brecker guidewire (CBG) was specifically designed for TAVR procedures.

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Confida Brecker Guidewire

RESOURCES

MANUALS AND TECHNICAL GUIDES

Access instructions for use and other technical manuals in the Medtronic Manual Library. Search by the product name (e.g., Evolut) or model number. You may also call 800-961-9055 for a copy of a manual.

Evolut PRO Platform Resources

pdf Evolut PRO System Product Brochure (.pdf)

919KB

Evolut PRO Product Brochure

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EDUCATION & RESOURCES

Find additional feature information, educational resources, and tools.

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*

Broadest annulus range based on CT derived diameters.

†

Measurement is for TAV-in-SAV only.

1

Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Curr Treat Options Cardiovasc Med. November 2016;18(11):67.

2

Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart. August 2006;92(8);1022-1029.

3

Flameng, W, et al. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Circulation. 2010; 121:2123-2129.

4

Up to 80% deployment. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. Third attempt must be a complete recapture and retrieval from patient.

The Confida™ Brecker guidewire (CBG) is specifically designed for TAVR procedures. To minimize risk of ventricular perforation, the CBG features a continuous tapered core. The guidewire curve is pre-shaped to help with anchoring during valve deployment.