Zenith Alpha System, Designed for Easy and Durable repairs. Prof. Elixène JEAN-BAPTISTE (Nice)
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1 Zenith Alpha System, Designed for Easy and Durable repairs Prof. Elixène JEAN-BAPTISTE (Nice)
2 Aortic Disease Can Progress AFTER Repair Resulting in: Stent migration Endoleaks Sac enlargement Secondary interventions
3 Keys to a Durable Repair? 1 A Seal in Healthy Tissue 2 Resistance to Endoleaks and Migration 3 Personalized Solutions 4 Precise and Controlled Deployment
4 1Seal in Healthy Tissue A durable EVAR requires a stable proximal aortic segment that is not wide, angulated, thrombus lined, calcified, conical-shaped or a combination of these features.
5 1Seal in Healthy Tissue Better patient selection Short neck Angulated Thrombus laden Large diameter aorta Inverted funnel
6 1Seal in Healthy Tissue Advances in concept & endograft technology
7 Keys to a Durable Repair? 1 A Seal in Healthy Tissue 2 Resistance to Endoleaks and Migration 3 Personalized Solutions Device-related 4 Precise and Controlled Deployment
8 Zenith Alpha Abdominal Low-profile main body device: Gold marker at the flow divider for increased visualization under fluoroscopy Completely new low-profile leg featuring nitinol Spiral- Z technology
9 2 Endoleak and Migration Resistance Resistance is based on three components Active fixation: barbs to anchor securely in healthy tissue Radial force: stents that help support the aorta and provide graft-to-vessel apposition Columnar strength: a balance of length, stability and flexibility The Zenith, a modular 3-piece bifurcated device with suprarenal support and 3 mm long fixation barbs, displayed the maximum proximal fixation capability Zenith alpha Based on the proven Zenith platform
10 Improvements: Migration Resistance(Pullout Force) Fixation barbs at two levels Zenith Alpha AAA Migration resistance 41.4N (Range ) Source MED TS080117, PMA submission Zenith Flex N Zenith PMA Submission
11 Keys to a Durable Repair? 1 A Seal in Healthy Tissue 2 Resistance to Endoleaks and Migration 3 Personalized Solutions 4 Precise and Controlled Deployment
12 3Personalized Solutions Devices need to adapt to the patient s individual vasculature to help ensure the best seal. Modularity and range of sizes allows for patient specific device configuration.
13 Planning and Sizing
14 ZISL: SPECIAL FEATURES For total ZISL length add 28 mm to the working length 3mm to the length of ZSLE (42, 59, 77, 93, 110, 125) Lower profile introducer system (12 Fr) Spiral-Z stent design (nitinol) with improved performance characteristics
15 New Gold markers on the Zenith Alpha Spiral-Z Endovascular Leg
16 Optimum overlap in the contralateral side
17 Optimum overlap in the ipsilateral side
18 Keys to a Durable Repair? 1 A Seal in Healthy Tissue 2 Resistance to Endoleaks and Migration 3 Personalized Solutions 4 Precise and Controlled Deployment
19 4Precise and Controlled Delivery Zenith alpha Features: Simplified Deployment More intuitive system New rotation handle Controlled, simple & precise deployment New Captor Sleeve Minimized deployment forces
20 4Precise and Controlled Delivery No top cap to retrieve Improved trackability No trigger wires to manually remove Trigger wires now remain contained within the new rotational handle
21 Zenith Alpha Thoracic Endovascular Graft
22 Device Overview Zenith Alpha Thoracic Endovascular Graft Indication: Aneurysms/ulcers of descending thoracic aorta Two-piece modular system Proximal and distal anchoring barbs Nitinol stents Graft diameters: mm Fr (ID) low profile introduction system
23 Notable Features: Highly Flexible Inner Nitinol Cannula Designed to improve deliverability and ensure proximal conformance Pre-curved introduction system cannula has candy cane shape that hugs the inner curve Bare proximal stent optimizes apposition Utilizes Pro-Form on mm diameters (not required on smaller sizes)
24 Notable Features: Intuitive Introduction System Rotation handle Kink-resistant Flexor sheath with hydrophilic coating Sheath length: 85 cm (10 cm longer than TX2 ) Introducer sheath mm, 16 Fr (19 Fr OD) mm, 18 Fr (21 Fr OD) mm, 20 Fr (23 Fr OD)* *40 46 mm sizes utilize Pro-Form
25 CONCLUSIONS Zenith Alpha Makes Durable Repair Easier Proven Design Based on the proven Zenith platform Designed to minimize endoleaks and reinterventions Intuitive Introduction System 3 simple steps to deployment Precise, controlled delivery The Right Device for the Right Patient A low profile Enables Improved Access and is Designed to Enhance Trackability An Extensive Range of Sizes to Suit Many Patient Types
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