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AXONE SIGNED

Commercial multiple electrode lead technology for cardiac disease

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

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

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 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.	FR (CLAMART)	coordinator	1˙373˙312.00
2	HERAEUS DEUTSCHLAND GMBH & CO KG HERAEUS DEUTSCHLAND GMBH & CO KG Organization address address: HERAEUSSTRASSE 12-14 city: HANAU postcode: 63450 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HANAU)	participant	537˙687.00
3	CENTRE HOSPITALIER UNIVERSITAIRE DE ROUEN CENTRE HOSPITALIER UNIVERSITAIRE DE ROUEN Organization address address: RUE DE GERMONT 1 city: ROUEN postcode: 76031 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (ROUEN)	participant	425˙062.00
4	UNIVERSITEIT MAASTRICHT UNIVERSITEIT MAASTRICHT Organization address address: Minderbroedersberg 4-6 city: MAASTRICHT postcode: 6200 MD website: http://www.maastrichtuniversity.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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.