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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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.
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.
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.
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.
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
*
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
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.
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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