aortic.medtronicendovascular.com Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Product Services Support Center Tel:.23.76 Fax: 00.3.3103 CardioVascular LifeLine Customer Support Tel: 77.526.790 Tel: 763.526.790 *Trademarks are the property of their respective owners wherever competitor trademarks are used. UC201202475EN Medtronic, Inc. 2014. All rights reserved. Printed in the USA. For distribution in the USA only. 03/14 Innovating for life.
PROveN & Performance Proven design and performance of the Valiant Captivia System now offers broader options to treat a wide range of patient anatomies. The Valiant Captivia System with proximal FreeFlo tapers continues to deliver the proven performance with additional components for broad patient suitability. 21% of patients in VALOr II trial (N=160) presented tapered aortas. THE Valiant Captivia System with proximal FreeFlo tapers helps you treat more anatomies with confidence. * 1. Proven design with enhanced conformability and kink resistance 2. Additional components to treat a wide range of anatomies 3. Tip capture for accuracy of positioning 4. Consistent clinical performance across a variety of pathologies 2 ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM *Data on file at Medtronic, Inc. 3
confidence in control The Valiant Captivia System features tip capture of the proximal stent. Tip capture provides controlled deployment and placement when navigating the thoracic aorta. CONTROLLED DEPLOYMENT WITH TIP CAPTURE Deployment Captured Released PLACEMENT RELEASE Tip capture provides accurate stent graft placement After tip capture is released, the Valiant Captivia System conforms to the patient s anatomy 4 ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM 5
CONFORMABILITY & OPTIMAL SEAL The Valiant Captivia System is designed to conform to the thoracic aorta. The sinusoidal shape and placement of nitinol springs provide flexibility and conformability to the anatomy. The Valiant is the only device that maintains complete apposition regardless of angulation and oversizing.* LACK OF APPOSITION 3.5 3 2.5 2 1.5 1 0.5 0 Angular flexibility & radial strength give the Valiant Captivia stent optimal seal* 70 0 90 100 110 120 130 140 ANGULATION 0 RELAY TX2 PRO-FORM C-TAG VALIANT 0% Results: The Valiant stent graft remained apposed to the aortic wall at each increment of neck angulation and degree of oversizing in a simulated environment. For the other stent grafts tested, lack of device wall apposition was observed between the proximal anchorage segment and the inferior aortic wall. PRE 3D reconstruction of patient anatomy POST Product Tested Medtronic Valiant Apposition at Different Landing Zone Angulation Body Apposition at Different Landing Zone Angulation Gore C-TAG Lack of apposition above 120 Bolton Relay TM Lack of apposition above 110 Cook Zenith TX2 Pro-Form Test data not indicative of clinical performance Lack of apposition above 110 *Ludovic Canaud, Philipe Cathala, Pierre Alric, Pascal Branchereau, Charles Henri Marty-Ané, (2013) Improvement in conformability of the latest generation of thoracic stent grafts. Journal of Vascular Surgery: April 2013, Vol. 57, No. 4 Fluoro shot of post index procedure result Pre and post-procedure images courtesy of The Heart Hospital Baylor Plano 6 ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM 7
OPTIMIzED ACCESS The Valiant Captivia System features a crossing profile similar to or lower than other thoracic stent grafts. Ease of access means control at every step, across a broad range of anatomies. Hydrophilic coating to facilitate stent graft delivery EASY THREESTEP DEPLOYMENT PROCESS TIP CAPTURE RELEASE HANDLE Simple turn-and-pull motion for tip release Step 1. Slow, controlled deployment for precise stent graft placement Device Profiles Step 2. Medtronic Valiant Bolton Relay Cook Zenith TX2 Pro-Form Gore C-Tag Quick deployment option if desired Crossing Profile (OD)* 24F 24F 26F 27F Hydrophilic Coating Yes Yes No No Sheath Required No No Yes Yes Step 3. Tip capture release System OD for Gore C-TAG & Cook Zenith list the OD of sheath as their IFUs recommend the use of a sheath. The System OD for Medtronic Valiant and Bolton Relay list the OD of the delivery catheter as the use of a sheath is not required per the respective IFUs. * 36 mm diameter graft used for comparison for all manufacturers except Gore. A 37 mm diameter graft used for Gore since no 36 mm diameter graft exists. ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM 9
DURABLE DESIGN The Valiant Captivia System is built on Medtronic s 15 years of thoracic stent graft experience and is proven in more than 50,000 implants. Our advanced design enhances confidence.* 1 2 3 1. -Peak FreeFlo Configuration Evenly distributes radial force over multiple apices 4 2. Figur Markers for Accurate Placement Platinum iridium markers provide high visibility 3. Eenhanced Conformability Absence of longitudinal bar allows for enhanced flexibility and kink resistance * Test data on file at Medtronic, Inc. Bench test results may not be indicative of clinical performance. 4. Broad Selection of Pieces Broad selection of proximal and distal components leads to many combinations to customize for a variety of patients 10 Valiant thoracic STENT graft WITH THE CAPTIVIA DelIVERy SySTEM 11
CLINICAL DATA BUILDING CONFIDENCE Proven performance across a variety of thoracic pathologies U.S. MEDTRONIC DISSECTION TRIAL Prospective, non-randomized, multi-center trial Outcomes of TEVAR in acute, type b aortic dissection: results from the VAliant us ide trial (N=50) 30-day and 1-year results The Valiant Captivia system demonstrates safety and effectiveness in the treatment of acute, complicated Type B aortic dissections. Medtronic U.S. Dissection Trial demonstrates positive aortic remodeling of stented segment the Valiant Captivia System successfully TREATS a broad range of pathologies and anatomies Comprehensive clinical studies and registries now support the use of TEVAR in patients with aortic dissections. CLINICAL TRIAL/STUDY VALOR (The Talent thoracic stent graft*) MEDTRONIC CLINICAL DATA SUPPORTS THE USE OF TEVAR ACROSS MULTIPLE PATHOLOGIES # PATIENTS ENROLLED 195 TRIAL STUDY DESIGN Prospective, non-randomized, multi-center U.S. IDE study conducted to evaluate the safety and effectiveness of the Talent stent graft system in patients with descending thoracic aneurysms 100% of eligible patients 100% 0% 60% 40% 20% 0% Evidence HIghlights 15 % 5% 94% 6 months 12 months False Lumen Volume 6% Decrease 3% 97% 6 months % all-cause mortality at 30D met primary safety endpoint 100% delivery and deployment success at implant 100% coverage of primary entry tear at implant 0% ruptures at 30 days and 12 months 100% 12 months True Lumen Volume Increase Stable INSTEAD-XL (The Talent thoracic stent graft) VALOR II (The Valiant stent graft) VIRTUE (The Valiant stent graft) VALIANT CAPTIVIA REGISTRY (The Valiant Captivia system) RESCUE (The Valiant Captivia system) Medtronic U.S. DISSECTION Trial (The Valiant Captivia system) 140 160 100 100 50 50 *The Talent thoracic stent graft is no longer commercially available in the U.S. Prospective, randomized controlled trial evaluating TEVAR+Optimal Medical Therapy vs Medical Therapy alone in uncomplicated Type B aortic dissections Prospective, non-randomized, multi-center U.S. IDE study conducted to evaluate the safety and effectiveness of the Valiant stent graft system in patients with descending thoracic aneurysms Prospective, non-randomized multi-center European registry evaluating Valiant in Type B aortic dissections Multi-center, non-interventional, single arm registry. Mid to high risk all comer cohort Prospective, non-randomized, multi-center U.S. IDE trial to evaluate device performance in blunt thoracic aortic injury Prospective, non-randomized, multi-center U.S. IDE trial to evaluate device performance in acute, complicated Type B aortic dissections Source: Valiant Captivia Instructions for Use, Summary of Clinical Studies 12 ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM 13
Component placement guide And Product codes ~12 mm Peak FreeFLO Straight ( component) 107 212 mm 22 46 mm Distinct radiopaque markers Figur marker 0 Zer0 marker ~12 mm Peak 0 0 22 46 mm FreeFlo TapeRED ( component) 152167mm 26 46 mm 22 42 mm closed web Straight (distal component) 100 205 mm 22 46 mm 26 46 mm 22 46 mm 0 22 46 mm CLosed web tapered (distal component) 150 160 mm 0 22 42 mm distal BArE SPRING straight (distal component) 107 117 mm 22 46 mm 0 ~12 mm Peak PROXIMAL FREEFLO STRAIGHT VAMF 22 22 C 100 TU 22 112 VAMF 24 24 C 100 TU 22 112 VAMF 26 26 C 100 TU 22 112 VAMF 2 2 C 100 TU 22 117 VAMF 30 30 C 100 TU 22 117 VAMF 32 32 C 100 TU 22 117 VAMF 34 34 C 100 TU 24 107 VAMF 36 36 C 100 TU 24 107 VAMF 3 3 C 100 TU 24 107 VAMF 40 40 C 100 TU 24 107 VAMF 42 42 C 100 TU 25 112 VAMF 44 44 C 100 TU 25 112 VAMF 46 46 C 100 TU 25 112 VAMF 22 22 C 150 TU 22 152 VAMF 24 24 C 150 TU 22 152 VAMF 26 26 C 150 TU 22 152 VAMF 2 2 C 150 TU 22 157 VAMF 30 30 C 150 TU 22 157 VAMF 32 32 C 150 TU 22 157 VAMF 34 34 C 150 TU 24 167 VAMF 36 36 C 150 TU 24 167 VAMF 3 3 C 150 TU 24 167 VAMF 40 40 C 150 TU 24 167 VAMF 42 42 C 150 TU 25 157 VAMF 44 44 C 150 TU 25 157 VAMF 46 46 C 150 TU 25 162 VAMF 30 30 C 200 TU 22 192 VAMF 32 32 C 200 TU 22 192 VAMF 34 34 C 200 TU 24 212 VAMF 36 36 C 200 TU 24 207 VAMF 3 3 C 200 TU 24 207 VAMF 40 40 C 200 TU 24 212 VAMF 42 42 C 200 TU 25 207 VAMF 44 44 C 200 TU 25 212 VAMF 46 46 C 200 TU 25 212 PROXIMAL FREEFLO TAPERED CLosed WEB TAPERED VAMF 26 22 C 150 TU 22 152 VAMF 2 24 C 150 TU 22 157 VAMF 30 26 C 150 TU 22 157 VAMF 32 2 C 150 TU 22 157 VAMF 34 30 C 150 TU 24 167 VAMF 36 32 C 150 TU 24 167 VAMF 3 34 C 150 TU 24 167 VAMF 40 36 C 150 TU 24 167 VAMF 42 3 C 150 TU 25 157 VAMF 44 40 C 150 TU 25 157 VAMF 46 42 C 150 TU 25 162 VAMC 26 22 C 150 TU 22 150 VAMC 2 24 C 150 TU 22 150 VAMC 30 26 C 150 TU 22 150 VAMC 32 2 C 150 TU 22 150 VAMC 34 30 C 150 TU 24 160 VAMC 36 32 C 150 TU 24 160 VAMC 3 34 C 150 TU 24 160 VAMC 40 36 C 150 TU 24 160 VAMC 42 3 C 150 TU 25 150 VAMC 44 40 C 150 TU 25 150 VAMC 46 42 C 150 TU 25 155 CLosed WEB STRAIGHT VAMC 22 22 C 100 TU 22 105 VAMC 24 24 C 100 TU 22 105 VAMC 26 26 C 100 TU 22 105 VAMC 2 2 C 100 TU 22 110 VAMC 30 30 C 100 TU 22 110 VAMC 32 32 C 100 TU 22 110 VAMC 34 34 C 100 TU 24 100 VAMC 36 36 C 100 TU 24 100 VAMC 3 3 C 100 TU 24 100 VAMC 40 40 C 100 TU 24 100 VAMC 42 42 C 100 TU 25 105 VAMC 44 44 C 100 TU 25 105 VAMC 46 46 C 100 TU 25 105 VAMC 22 22 C 150 TU 22 145 VAMC 24 24 C 150 TU 22 145 VAMC 26 26 C 150 TU 22 145 VAMC 2 2 C 150 TU 22 150 VAMC 30 30 C 150 TU 22 150 VAMC 32 32 C 150 TU 22 150 VAMC 34 34 C 150 TU 24 160 VAMC 36 36 C 150 TU 24 160 VAMC 3 3 C 150 TU 24 160 VAMC 40 40 C 150 TU 24 160 VAMC 42 42 C 150 TU 25 150 VAMC 44 44 C 150 TU 25 150 VAMC 46 46 C 150 TU 25 155 VAMC 30 30 C 200 TU 22 15 VAMC 32 32 C 200 TU 22 15 VAMC 34 34 C 200 TU 24 205 VAMC 36 36 C 200 TU 24 200 VAMC 3 3 C 200 TU 24 200 VAMC 40 40 C 200 TU 24 205 VAMC 42 42 C 200 TU 25 200 VAMC 44 44 C 200 TU 25 205 VAMC 46 46 C 200 TU 25 205 DISTAL Bare SPRING STRAIGHT VAMC 22 22 B 100 TU 22 112 VAMC 24 24 B 100 TU 22 112 VAMC 26 26 B 100 TU 22 112 VAMC 2 2 B 100 TU 22 117 VAMC 30 30 B 100 TU 22 117 VAMC 32 32 B 100 TU 22 117 VAMC 34 34 B 100 TU 24 107 VAMC 36 36 B 100 TU 24 107 VAMC 3 3 B 100 TU 24 107 VAMC 40 40 B 100 TU 24 107 VAMC 42 42 B 100 TU 25 112 VAMC 44 44 B 100 TU 25 112 VAMC 46 46 B 100 TU 25 112 14 ValIANT thoracic stent graft WITH THE CAPTIVIA DelIVERy SySTEM 15