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

Project Information

CARDISENSE

Grant agreement ID: 673885

DOI

10.3030/673885

Project closed

EC signature date 27 April 2015

Start date 1 May 2015

End date 31 October 2015

Funded under

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

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

CARDIACCS AS
Norway

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

Reporting period: 2015-05-01 to 2015-10-31

Summary of the context and overall objectives of the project

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

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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