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AXONE SIGNED

Commercial multiple electrode lead technology for cardiac disease

Total Cost €

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EC-Contrib. €

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Partnership

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 AXONE project word cloud

Explore the words cloud of the AXONE project. It provides you a very rough idea of what is the project "AXONE" about.

25    commercial    placed    validation    positive    class    sales    manufacture    confirm    single    projected    efficiency    spaced    left    plan    14    impressive    chronic    is4    million    cardiac    reducing    2020    device    considerably    axone    leaving    rate    compete    initiated    heart    previously    advantages    times    place    performance    vary    selling    population    decrease    70    acute    implantation    perform    direct    resynchronization    therapy    industrialization    launch    procedure    leads    market    stimulate    coronary    time    marketing    finalise    generates    individual    give    responder    pacing    yearly    50    finalize    definition    combines    medical    pacemaker    commercialization    global    dominated    people    prepare    diameter    marking    ce    start    2026    effect    vein    file    sites    capability    site    revenues    82    clinical    crt    healthcare    patients    companies    smaller    ventricle    commercialisation    depending    generation    benefits    opportunity   

Project "AXONE" data sheet

The following table provides information about the project.

Coordinator
SORIN CRM SAS 

Organization address
address: AVENUE REAUMUR 4
city: CLAMART
postcode: 92140
website: www.sorin-crm.com

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Project website http://www.crm.microport.com/
 Total cost 3˙513˙187 €
 EC max contribution 2˙694˙187 € (77%)
 Programme 1. H2020-EU.3. (PRIORITY 'Societal challenges)
2. H2020-EU.2. (PRIORITY 'Industrial leadership')
 Code Call H2020-FTIPilot-2016-1
 Funding Scheme IA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2019-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    SORIN CRM SAS FR (CLAMART) coordinator 1˙373˙312.00
2    HERAEUS DEUTSCHLAND GMBH & CO KG DE (HANAU) participant 537˙687.00
3    CENTRE HOSPITALIER UNIVERSITAIRE DE ROUEN FR (ROUEN) participant 425˙062.00
4    UNIVERSITEIT MAASTRICHT NL (MAASTRICHT) participant 358˙125.00

Map

 Project objective

Heart failure affects more than 14 million people in Europe, and is projected to affect about 30 million people by 2020. While the effects of Cardiac Resynchronization Therapy on the wider heart failure population are impressive, benefits at the individual level vary considerably. Depending on the definition, the responder rate CRT is positive in 50-70% of patients, leaving 30-50% without any significant effect. This project will finalise the development of a pacemaker cardiac lead that is 5 times smaller diameter than the state-of-the-art, and start the commercialisation of the product. The project will directly improve the efficiency of Cardiac Resynchronization Therapy (CRT) by reducing the time required for the implantation procedure by 25%, and decrease the yearly healthcare costs by 82 M€/year in Europe. In addition, the project will help European companies to compete in the pacemaker market currently dominated by US companies. Axone IS4 lead combines the advantages of a single lead, which is easy to place in any coronary vein, with the capability to stimulate the left ventricle at 2 widely spaced sites for a more global resynchronization – this has previously required 2 leads to be placed in the heart. The objective of the AXONE project is to: • Finalize product industrialization. • Confirm chronic pre-clinical performance with large scale studies. • Perform an acute clinical study and a chronic clinical validation. • Manufacture clinical and commercial products. • Build the marketing plan and prepare the product launch. • File CE marking of the class III medical device system. • Launch the commercialization of AXONE system and start selling the system in Europe. This novel approach of multi-site pacing has the potential to become the next CRT therapy device generation, initiated in Europe. This project will give an opportunity to generates 90 M€ direct revenues sales in 2026.

 Deliverables

List of deliverables.
Final acute clinical study report Documents, reports 2019-05-31 10:02:15
AXONE benefit over standard CRT report Documents, reports 2019-05-31 10:02:12
Preclinical safety performance report Documents, reports 2019-05-31 10:02:12

Take a look to the deliverables list in detail:  detailed list of AXONE deliverables.

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The information about "AXONE" are provided by the European Opendata Portal: CORDIS opendata.

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