references: evolut r - share your case€¦ · medtronic data on file, ... case postale ch-1131...

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REFERENCES: 1. Medtronic, Inc. IFU M054712T001. 2. Sheath to Femoral Artery Ratio (SFAR) greater than 1.05 predicted higher rates of VARC major vascular complications. Hayashida K, et al. Transfemoral aortic valve implantation. JACC Intv 2011;4(8):851-8. 3. Genereux P, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of Aortic Transcatheter Valve) trial. JACC 2012;60(12):1043-52. 4. Tchetche D, et al. Update on the need for a permanent pacemaker after transcatheter valve implantation using the CoreValve ® AccuTrak system. EuroIntervention 2012 Sep; 8(5):556-62. 5. Medtronic data on file, comparison of CoreValve to CoreValve Evolut/Evolut R. Significant PVL defined as ≥ moderate PVL. 6. Popma J, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. JACC 2014;63(19):1972-81. medtronic.eu // CoreValveEvolutR.com World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals) Europe Medtronic International Trading Sàrl Route du Molliau 31 Case postale CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900 Canada Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Canada Tel: (905) 826-6020 Fax: (905) 826-6620 Toll-free: 1 (800) 268-5346 Asia Pacific Medtronic International, Ltd. 16/F Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel: (852) 2891 4456 Fax: (852) 2891 6830 [email protected] Latin America Medtronic USA, Inc. Doral Corporate Center II 3750 NW 87th Avenue Suite 700 Miami, FL 33178 USA Tel: (305) 500-9328 Fax: (786) 709-4244 LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 E-mail: [email protected] UC201501116a EE ©2015 Medtronic, Inc. All rights reserved. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. Evolut, EnVeo, InLine, AOA, AccuTrak, and Confida are trademarks of Medtronic, Inc. INTERNATIONAL CAUTION: For distribution only in markets where CoreValve Evolut R has been approved. Non destiné au marché français. Refer to Instructions for Use for a complete list of warnings, precautions and contraindications. Evolut R CoreValve ® TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) SYSTEM INTERNATIONAL CAUTION: For distribution only in markets where CoreValve Evolut R has been approved. Non destiné au marché français. Confidence. Delivered. Confidence. Delivered.

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RefeRences: 1. Medtronic, Inc. IfU M054712T001.2. sheath to femoral Artery Ratio (sfAR) greater than 1.05 predicted higher rates

of VARc major vascular complications. Hayashida K, et al. Transfemoral aortic valve implantation. JAcc Intv 2011;4(8):851-8.

3. Genereux P, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTneR (Placement of Aortic Transcatheter Valve) trial. JAcc 2012;60(12):1043-52.

4. Tchetche D, et al. Update on the need for a permanent pacemaker after transcatheter valve implantation using the coreValve® AccuTrak™ system. euroIntervention 2012 sep; 8(5):556-62.

5. Medtronic data on file, comparison of coreValve to coreValve evolut/evolut R. significant PVL defined as ≥ moderate PVL.

6. Popma J, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. JAcc 2014;63(19):1972-81.

medtronic.eu // CoreValveEvolutR.com

World HeadquartersMedtronic, Inc.710 Medtronic ParkwayMinneapolis, Mn 55432-5604UsATel: (763) 514-4000fax: (763) 514-4879

Medtronic UsA, Inc.Toll-free: 1 (800) 328-2518(24-hour technical support forphysicians and medical professionals)

EuropeMedtronic International Trading SàrlRoute du Molliau 31case postalecH-1131 TolochenazswitzerlandTel: 41.21.802.7000fax: 41.21.802.7900

CanadaMedtronic of canada Ltd.6733 Kitimat RoadMississauga, Ontario L5n 1W3canadaTel: (905) 826-6020fax: (905) 826-6620Toll-free: 1 (800) 268-5346

Asia PacificMedtronic International, Ltd.16/f Manulife PlazaThe Lee Gardens, 33 Hysan Avenuecauseway BayHong KongTel: (852) 2891 4456fax: (852) 2891 [email protected]

Latin AmericaMedtronic UsA, Inc.Doral corporate center II3750 nW 87th Avenue suite 700Miami, fL 33178UsATel: (305) 500-9328fax: (786) 709-4244

LifeLineCardioVascular Technical Support Tel: (877) 526-7890Tel: (763) 526-7890fax: (763) 526-7888e-mail: [email protected]

UC201501116a EE ©2015 Medtronic, Inc. All rights reserved.

coreValve is a registered trademark of Medtronic cV Luxembourg s.a.r.l. evolut, enVeo, InLine, AOA, AccuTrak, and confida are trademarks of Medtronic, Inc.

InTeRnATIOnALcAUTIOn: for distribution only in markets where coreValve evolut R has been approved. non destiné au marché français.

Refer to Instructions for Use for a complete list of warnings, precautions and contraindications.

Evolut™ RCoreValve®

TRAnsCAThETER AoRTIC VAlVE IMplAnTATIon (TAVI) sysTEM

InTeRnATIOnALcAUTIOn: for distribution only in markets where coreValve evolut R has been approved. non destiné au marché français.

Conf idence. Delivered.

Conf idence. Delivered.

Built on the proven Foundation of the CoreValve® platform

As TAVI therapy offers more patients hope for the treatment of severe aortic stenosis, our responsibility as an industry leader grows.

Medtronic is committed to advancing technology and evidence to further optimize patient outcomes and enhance TAVI therapy.

CE Pivotal ADVANCE

US Pivotal • Extreme Risk

US Pivotal • High Risk

Japan

Conf idence. Delivered.

coreValve® evolut™ R system

R

CE Pivotal ADVANCE

US Pivotal • Extreme Risk

US Pivotal • High Risk

Japan SURTAVI CoreValve Evolut R CE

CoreValve Evolut R US

E x t E n d i n g t h E F o u n d a t i o n o F E v i d E n c E F r o m > 11 , 0 0 0 P a t i E n t s

lowest Delivery profile Across All Valve sizes 14Fr-Equivalent system with Inline™ sheath Improves Access1 and Reduces Risk of Major Vascular Complications2

Larger sheath size has been shown to increase the rate of major vascular

complications2 and mortality.3

drawn to scale. not actual French sizes.

RA c c e s s W I T H c O n f I D e n c e

now indicated for transarterial access vessel

diameters ≥ 5.0mm.1

CoreValve®

22 Fr (OD)

with 14Fr-EquivalentInLine™ Sheath

Evolut™ Rwith 18Fr

Cook Sheath

True 18Fr (OD)

18Fr 18Fr

4fr Reduction in Delivery Profile

1:1 Response

Response between the catheter handle and the deployment of the valve clearly demonstrates no lag in the delivery system.

Self-Centering

capsule flare and flexible catheter design enable uniform and controlled valve expansion and self-centering of the valve in the annulus.

option to Fully Recapture and Reposition*

*Up to ~80% deployment. Medtronic Data on File.

R

For added assurance of accurate placement, the EnVeo™ R delivery system provides the option

to fully recapture and reposition the valve.

Valve positioned too deep

Recapture begins Partially recaptured Valve fully recaptured

P O s I T I O n W I T H c O n f I D e n c e

Designed for 1st Time positioning Accuracy With 1:1 Response and self-Centering

Positioning accuracy is associated with reduced procedural complications, including reduced

rates of PVL and conduction disturbances.4

Exceptional Valve performance and Reduced significant pVl5

Reduction in significant paravalvular leakage is associated

with increased survival.6

Evolut™ R valve maintains the supra-annular valve design of the CoreValve® platform. The frame properties allow for a good seal

in the annulus and contribute to reduced paravalvular leak.

RP e R f O R M A n c e W I T H c O n f I D e n c e

With optimized oversizing, Consistent Radial Force, and Extended sealing skirt*supra-

annular Valve

Optimizes coaptation in non-circular anatomy with supra-annular valve position

conforms to the native annulus

CT Image Source: PPT de Jaegere, C.J. Schultz, Thoraxcenter, Erasmus University, Rotterdam, The Netherlands.

Annulus

More Consistent Radial Force Across the Annulus Diameter

evolut™ R nitinol frame provides consistent radial force for improved sealing and PVL performance.

Optimized Oversizing

sizing optimized for annulus diameter range and implant depth.

* Available on 26 and 29 mm valve sizes. ** Based on combined radial force curve for CoreValve 26, 29 and 31 mm transcatheter valves.

In�o

w R

adia

l For

ceAnnulus Diameter Range (mm)

CoreValve**Evolut R FamilyDesign Target Range

Annulus Diameter Range (mm)

Ove

rsizi

ng (%

)

Evolut R FamilyDesign Target (Min)

Building the future of TAVI with over 1,000 hours of physician collaboration in designing and testing the Evolut™ R system