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Zenith Alpha System™, Designed for Easy and Durable repairs
Prof. Elixène JEAN-BAPTISTE
(Nice)
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Aortic Disease Can Progress AFTER Repair
• Resulting in:
– Stent migration
– Endoleaks
– Sac enlargement
– Secondary interventions
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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
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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.”
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Better patient selectionShort neck Angulated Thrombus laden
Large diameter aorta Inverted funnel
①Seal in Healthy Tissue
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Advances in concept & endograft technology
①Seal in Healthy Tissue
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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
Device-related
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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
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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
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Improvements: Migration Resistance(Pullout Force)
Migration resistance
Source
Zenith Alpha AAA
41.4N (Range 34.3-48.8)
MED TS080117, PMA submission
Zenith Flex 36.6 +2.4N Zenith PMA Submission
Fixation barbs at two levels
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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
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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.
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Planning and Sizing
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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
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New Gold markers on the Zenith Alpha Spiral-Z Endovascular Leg
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Optimum overlap in the contralateral side
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Optimum overlap in the ipsilateral side
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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
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Zenith alpha Features: Simplified Deployment
• More intuitive system
• New rotation handle– Controlled, simple & precise deployment
• New Captor Sleeve– Minimized deployment forces
④Precise and Controlled Delivery
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• No top cap to retrieve– Improved trackability
• No trigger wires to manually remove– Trigger wires now remain contained within the new rotational handle
④Precise and Controlled Delivery
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Zenith Alpha™ Thoracic Endovascular Graft
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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: 18-46 mm
• 16-20 Fr (ID) low profile introduction system
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Notable Features: Highly Flexible Inner Nitinol Cannula
Designed to improve deliverability and ensure proximalconformance
• Pre-curved introduction system—cannula has “candy cane” shape thathugs the inner curve
• Bare proximal stent optimizes apposition
• Utilizes Pro-Form™ on 40–46 mm diameters (not required on smaller sizes)
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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– 18–30 mm, 16 Fr (19 Fr OD)– 32–38 mm, 18 Fr (21 Fr OD)– 40–46 mm, 20 Fr (23 Fr OD)*
*40–46 mm sizes utilize Pro-Form™
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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 EnhanceTrackability
• An Extensive Range of Sizes to Suit Many Patient Types