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Evolut™ R system Transcatheter Aortic Valve Replacement (TAVI)

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

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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 gemodynamics

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 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.

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

Lowest delivery profile
The 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 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 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. 

*

Broadest annulus range based on CT derived diameters.

Measurement is for TAV-in-SAV only.

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.