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Healthcare Professionals

Evolut™ R System

Transcatheter Aortic Valve Implantation (TAVI)

Overview

The Evolut™ R Transcatheter Aortic Heart Valve, built on the proven foundation of the CoreValve™ platform, 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 EvolutTM 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 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 and oversizing feature of the nitinol frame maximize the valve orifice and leaflet coaptation.1

Image of a the Evolut TAVI Circularity Leaflet Coaptation

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

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

*Broadest annulus range based on CT derived diameters.

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

Profile image of the EnVeo PRO delivery system

EnVeo PRO Delivery System

Recapture and reposition
The EnVeoTM 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 EnVeoTM PRO delivery system provides you the option to recapture and reposition2 for more accurate placement.

Fluoroscopic image of the EnVeo PRO two-thirds deployed

The Confida Brecker Guidewire (CBG) is specifically designed for TAVI 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.

The Confida Brecker Guidewire (CBG) is specifically designed for TAVI 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.

Confida Brecker Guidewire
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.

2

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.