Innovative sensor for continuous monitoring of heart function during and after surgery

Información del proyecto

CARDISENSE

Identificador del acuerdo de subvención: 673885

DOI

10.3030/673885

Proyecto cerrado

Fecha de la firma de la CE 27 Abril 2015

Fecha de inicio 1 Mayo 2015

Fecha de finalización 31 Octubre 2015

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

CARDIACCS AS
Norway

Periodic Reporting for period 1 - CARDISENSE (Innovative sensor for continuous monitoring of heart function during and after surgery)

Período documentado: 2015-05-01 hasta 2015-10-31

Resumen del contexto y de los objetivos generales del proyecto

The project aims to develop a commercial product of the sensor “CardiSense” for use in patients undergoing open heart surgery, in order to reduce complications and mortality. The Objectives of the phase 1 Feasibility Study includes:
O1: Analyse existing players’ product portfolio and identify gaps in product lines
O2: Complete functional requirements and identify manufacturing sub-contract partners
O3: Prepare models for supply chain based on business plan modelling. Prepare product development and commercial supply chain for selected business model.
O4: Perform financial risk analysis for each market segment based on the outcome of O1, O2 and O3

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

Cardiaccs has identified suppliers for design and manufacturing and has established plans for realization of the final product. A company quality system conforming to regulatory requirements has been established and Cardiaccs is ready to develop and manufacture CardiSense. Key parameters for pre-clinical as well as clinical validation have been identified to demonstrate that CardiSense is faster at detecting ischemia than electrocardiography. Existing players have been evaluated and technology gaps have been identified. We conclude that current intra- and post-operative heart monitoring techniques lack either sensitivity or specificity in the detection of myocardial ischemia. Cardiaccs has identified Germany as the largest cardiac surgical market in the EU and CardiSense fits well within the German reimbursements system, allowing Cardiaccs to target this market following initial clinical studies in Scandinavia. Cardiaccs has identified companies is both Norway and Germany that are eager to include CardiSense in their existing product portfolio.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

Myocardial ischaemia is caused by severe impairment of coronary blood supply to a given section of the heart muscle, which may result in infarction. Therefore, under all circumstances, the early detection of ischaemia is crucial to avoid the death of vital tissues as the myocardium. With existing monitoring techniques, myocardial ischaemia may escape detection in cardiac surgeries, which may affect appropriate and timely intervention by the physicians. There is a significant potential for continuous monitoring of myocardial contractility in cardiac surgeries intra- and postoperatively to enable the early detection of ischaemia – thereby preventing infarction of the myocardium – safeguarding the well being of patients and avoiding major economic burden to health systems.

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