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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.

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

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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