Zenith Alpha System™, Designed for Easy and Durable repairs

Prof. Elixène JEAN-BAPTISTE

(Nice)

Aortic Disease Can Progress AFTER Repair

• Resulting in:

– Stent migration

– Endoleaks

– Sac enlargement

– Secondary interventions

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

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.”

Better patient selectionShort neck Angulated Thrombus laden

Large diameter aorta Inverted funnel

①Seal in Healthy Tissue

Advances in concept & endograft technology

①Seal in Healthy Tissue

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

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

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

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

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

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.

Planning and Sizing

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

New Gold markers on the Zenith Alpha Spiral-Z Endovascular Leg

Optimum overlap in the contralateral side

Optimum overlap in the ipsilateral side

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

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

• 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

Zenith Alpha™ Thoracic Endovascular Graft

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

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)

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™

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