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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.

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

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

Leaflet | Map data © OpenStreetMap contributors, CC-BY-SA, Imagery © Mapbox

 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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