Alert Indications, Safety, and Warnings

EVOLUT R SYSTEM Transcatheter Aortic Valve Replacement (TAVI)

The EvolutTM R valve was built on the proven design of our CoreValveTM system.  The Evolut R valve features a supra-annular design and low delivery profile.

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Evolut R 29mm
Alert Indications, Safety, and Warnings

Overview

Meet the Evolut R System

The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus.

Sideview of the Evolut R Transcatheter Aortic Valve

PRODUCT DETAILS

Proven Platform

The Evolut R valve is built on a proven platform, which continues to demonstrate exceptional outcomes.

  • The valve is made from strong and pliable porcine pericardial tissue, making it durable and allowing for a low-profile delivery.
  • The self-expanding nitinol frame conforms and adapts to the annulus and provides consistent, outward radial force.
  • The supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large effective orifice areas (EOAs).

   

Industry-Leading Hemodynamics

The supra-annular valve design of the nitinol frame maximizes the valve orifice and leaflet coaptation.1

The Evolut R valve design promotes single-digit gradients and large effective orifice areas (EOAs): The supra-annular valve optimizes coaptation in noncircular anatomy with supra-annular valve position and conforms to the native annulus.

FPO

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 TAVI procedure because of the expanded annulus range.

Image showing the annulus range of the Evolut R Transcatheter Aortic Valve

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.

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

Image of the EnVeo PRO delivery system featuring accurate positioning

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. 

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EDUCATION & RESOURCES

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*

Broadest annulus range based on CT derived diameters.

†

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.

1

Popma JJ, Reardon MJ, Khabbaz K, et al. Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study. JACC Cardiovasc Interv. February 13, 2017;10(3):268-275.

DISCLAIMER

See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO and the Evolut™ PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 

For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser. 

The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut™ PRO System, and the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System.

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