eferences: 1. sheath to Femoral Artery atio (SFA) greater than 1.05 predicted higher rates of VAC major vascular complications. Hayashida K, et al. Transfemoral aortic valve implantation. JACC Intv 2011;4(8):851-8. 2. Genereux P, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PATN (Placement of Aortic Transcatheter Valve) trial. JACC 2012;60(12):1043-52. 3. Tchetche D, et al. Update on the need for a permanent pacemaker after transcatheter valve implantation using the CoreValve AccuTrak system. urointervention 2012 Sep; 8(5):556-62. 4. Medtronic data on file, comparison of CoreValve to CoreValve volut. 5. 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. CoreValve volut Transcatheter Aortic Valve Implantation (TAVI) System INTNATIONAL CAUTION: For distribution only in markets where CoreValve volut has been approved. Non destiné au marché français. efer to Instructions for Use for a complete list of warnings, precautions and contraindications. Conf idence. Delivered. medtronic.eu // CoreValvevolut.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) urope Medtronic International Trading Sàrl oute 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 oad 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 enquiryap@medtronic.com 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 -mail: rs.cstechsupport@medtronic.com CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. volut, nveo, InLine, AOA, AccuTrak, and Confida are trademarks of Medtronic, Inc. UC201501116 2014 Medtronic, Inc. All rights reserved. INTNATIONAL CAUTION: For distribution only in markets where CoreValve volut has been approved. Non destiné au marché français. Conf idence. Delivered.
Built on the Proven Foundation of the CoreValve Platform t s tal C Pivo ADVANC US Piv otal xtrem e is k oun the F g n i d n e xt US P ivota l Hi gh isk 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. Japan SUTAVI d at ion v of ide r e f nc om >1 1, 0 00 Pa l eva Cor e ti n ut vol ve S U lut C o v e v CoreVal CoreValve volut System
A c c e s s w i t h C o n f i d e n c e Lowest Delivery Profile, 14Fr-quivalent System with InLine Sheath Larger sheath size has been shown to increase the rate of major vascular complications 1 and mortality. 2 Improves Access and educes isk of Major Vascular Complications 1 The nveo with InLine Sheath is a14fr-equivalent delivery system the lowest profile on the market for transarterial delivery. 4Fr eduction in Delivery Profile CoreValve with 18Fr Cook Sheath volut with 14Fr-quivalent InLine Sheath 18Fr 22 Fr (OD) 18Fr True 18Fr (OD) Drawn to scale. Not actual French sizes.
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 esponse and Self-Centering Option to Fully ecapture and eposition * Positioning accuracy is associated with reduced procedural complications, including reduced rates of PVL and conduction disturbances. 3 1:1 esponse esponse between the catheter handle and the deployment of the valve clearly demonstrates no lag in the delivery system. Valve positioned too deep ecapture begins Partially recaptured Valve fully recaptured Self-Centering capsule flare and flexible catheter design enable uniform and controlled valve expansion and self-centering of the valve in the annulus. *Up to ~80% deployment. Medtronic Data on File. For added assurance of accurate placement, the nveo delivery system provides the option to fully recapture and reposition the valve.
P e r f o r m a n c e w i t h C o n f i d e n c e xceptional Valve Performance and educed PVL 4 With Optimized Cover Index and Consistent adial Force eduction in significant paravalvular leakage is associated with increased survival. 5 Inflow adial Force CoreValve volut Supraannular Valve Annulus Optimizes coaptation in non-circular anatomy with supra-annular valve position Annulus Diameter ange (mm) Conforms to the native annulus Optimized Cover Index Sizing optimized for annulus diameter range and implant depth. More Consistent adial Force Across the Annulus Diameter The volut valve features a self-expanding Nitinol frame that provides consistent radial force for improved sealing and PVL performance, and anchoring of the valve. volut 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. Images courtesy of Drs. de Jaegere and Schultz, rasmus MC, otterdam, The Netherlands.
Building the future of TAVI with over 1,000 hours of physician collaboration in designing and testing the volut System Conf idence. Delivered.