Novel Catheter for the Diagnosis of Cardiovascular Disease

Informations projet

Wirecath

N° de convention de subvention: 878216

DOI

10.3030/878216

Projet clôturé

Date de signature de la CE 11 Juillet 2019

Date de début 1 Août 2019

Date de fin 31 Janvier 2020

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

CAVIS TECHNOLOGIES AB
Sweden

Periodic Reporting for period 1 - Wirecath (Novel Catheter for the Diagnosis of Cardiovascular Disease)

Période du rapport: 2019-08-01 au 2020-01-31

Résumé du contexte et des objectifs généraux du projet

Cavis Technologies has an objective to clinically validate and commercialise Wirecath® – its novel medical device for assessing the severity of narrowing in the coronary arteries. It has the potential to substantially reduce management costs in coronary artery disease by improving its diagnosis, and thus, increasing opportunity for timely prevention of disease progression and its severe complications, such as angina, shortness of breath and heart attack. Wirecath® has several premium features over competing solutions. These are high accuracy, superior manoeuvrability and cost-effectiveness. It’s simple and robust design is based on a unique position of the pressure sensor and resistance to hydrostatic error, that standard pressure wires are liable to.
With this project, Cavis intends to plan further product development and large-scale clinical evaluation studies that will follow the first-in-man study. Cavis’ current research and development activities are supported by investment from shareholders and numerous innovation grants.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

The concluded SME Instrument Phase I project highlighted a strong technical and commercial viability of the product. Cavis conducted numerous interviews with cardiologists from Sweden, the Netherlands and the UK in order to gather feedback on Wirecath®. The overall response was very positive and concerned mostly with the device’s superior wire manoeuvrability as well as measurement accuracy.
The company has also confirmed that its further clinical strategy will consist of three serial studies. In this respect, the team together with KOLS and cardiologist have developed two large-scale clinical study synopsis.

The strategic business review allowed for further study of the competitive landscape and led to strengthening Cavis strategy for market entry. Cavis have identified several important partners and distributors. The established strategy on how to engage with external partners will support the product’s international expansion and the company’s growth.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

With 1.9 million deaths a year, cardiovascular diseases are the leading cause of death in the EU and place a considerable burden on healthcare systems and government budgets. As the prevention and treatment of various cardiovascular diseases, including coronary artery disease, is of a high strategic priority across the EU, Cavis foresees the enormous potential for Wirecath to improve the diagnosis of this condition and contribute to the prevention and management of cardiovascular disease problem. Cavis’ vision is that all patients should receive a diagnosis of their problems that will enable them to be treated effectively. Wirecath® will contribute to improvement in the CAD diagnosis, optimising appropriate treatment. It will bring long-lasting benefits to medical professionals and patients with coronary artery disease. It will also contribute to substantial cost savings in the healthcare budgets.

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