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TAVI ALLEGRA:

ÚLTIMOS RESULTADOS CLÍNICOS Y NUEVOS PROYECTOS

Dr. Muñoz García

H.C.U. Virgen de la Victoria. Málaga

Sin conflictos que declarar

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Cardiovasc Interv. 2021;98:365–370.

TAVI ALLEGRA: ÚLTIMOS RESULTADOS CLÍNICOS

CONSOLIDACIÓN EN EL VALVE- IN-VALVE

EuroIntervention 2020;15:e1335-e1342

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TAVI ALLEGRA: ÚLTIMOS RESULTADOS CLÍNICOS

CONSOLIDACIÓN EN EL VALVE- IN-VALVE

None/trace

Mild

Schäffer U, et al.. EuroIntervention 2019;15:e757-e763.

ALLEGRA VIV PROCEDURES: VIVALL STUDY

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Occlusion free Permaflow
3-step deployment technique
Fully-retrievable

New ergonomic handle design
Self-locking function of safety locker
Re-sheathable, repositionable and fully-retrievable

Next generation delivery system for ALLEGRA^TM Transcatheter Heart Valve

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Ergonomic design with low profile according to new corporate design

Release Handle for unsheathing and re-sheathing

Lock-Unlock Selector as safety mechanism

New product tray

18 Fr catheter system with reinforced integrated sheath

Key features of IMPERIA^TM Delivery System

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New generation of ALLEGRA^TM transcatheter heart valve: optimized valve design with outer sealing mechanism

Sealing

Unique outer sealing mechanism for improving sealing capability

Implementation of web cut design on the valve inflow aspect

Stent frame

Latest generation of nitinol used

Valve design optimized for re-sheathing

Increased stent frame cells to further ease coronary access

Optimized T-bars for less footprint

Optimized 31mm valve with new inflow aspect

ALLEGRA^TM Plus Transcatheter Heart Valve

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Unique V-shaped sealing improves sealing capability of the valve by folding outward and hindering the blood flow

ALLEGRA^TM Plus Transcatheter Heart Valve: Unique outer sealing

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Clinical investigation of IMPERIA^TM DS to allow full repositioning of ALLEGRA^TM THV

Multi-national single arm study for regulatory approval

107 patients for CE mark under EU-MDR

Primary outcome at 30 days – safety and efficacy

FPI - Jan 2023

13 Sites in United Kingdom (4), Germany (3), Spain (3), Netherlands (3)

EMPIRE 1 – Clinical Study

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Allegra Plus (valves made in Germany, DS in Singapore)

Multi-national single arm study for regulatory approval in Europe (CE mark)

Up to 20 centres in Europe

PEP: All cause mortality/stroke at 1 year

Sub-studies

Bicuspid valves

ViV

FPI May 2023

Minimum 400 patient-years follow-up

EMPIRE 2 – Imperia + Allegra Plus

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EMPIRE China – Imperia + Allegra Plus

Allegra Plus (valves made in Shanghai; DS in Singapore)

13 centres in China

Single arm study for regulatory approval in China (CFDA)

PEP: All cause mortality at 1 year

Sample size 126 patients

Bicuspid valves included (50% of patients in China)

FPI March 2023