Healthcare Professionals

Evolut™ PRO System

Transcatheter Aortic Valve Implantation (TAVI)

Overview

The Evolut^TM PRO system is the next-generation, self-expanding transcatheter aortic valve with exceptional design and advanced sealing capability. The Evolut^TM PRO system 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.

PRODUCT DETAILS

EXCEPTIONAL DESIGN

The Evolut^TM PRO valve features an external porcine pericardial 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.

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

THE HEMODYNAMIC ADVANTAGE OF THE EVOLUT^TM TAVI PLATFORM

The Evolut^TM TAVI 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^TM 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

Topview of the Evolut R Transcatheter Aortic Valve

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

CONTROL AND ACCESS

Features of the EnVeo^TM 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 PRO Transcatheter Aortic Valve

*Broadest annulus range based on CT derived diameters.

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

EnVeo PRO Delivery System

Recapture and reposition
The EnVeo^TM 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^TM PRO delivery system provides you the option to recapture and reposition⁴ for more accurate placement.

Image of the EnVeo PRO delivery system featuring accurate positioning

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.

MANUALS AND TECHNICAL GUIDES

pdf Evolut^TM PRO System Product Brochure (.pdf)

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

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

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.