A MINIMALLY INVASIVE NEEDLE FREE DEVICE TO SAFELY ACCESS THE PERICARDIUM SPACE

Informazioni relative al progetto

ViaOne

ID dell’accordo di sovvenzione: 868213

DOI

10.3030/868213

Progetto chiuso

Data della firma CE 17 Aprile 2019

Data di avvio 1 Maggio 2019

Data di completamento 30 Settembre 2019

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

CARDIOVIA LTD.
Israel

Periodic Reporting for period 1 - ViaOne (A MINIMALLY INVASIVE NEEDLE FREE DEVICE TO SAFELY ACCESS THE PERICARDIUM SPACE)

Periodo di rendicontazione: 2019-05-01 al 2019-09-30

Sintesi del contesto e degli obiettivi generali del progetto

ViaOne is a minimally invasive, cost-effective medical device that allows safe, needle free exposure access to the outer surface of the heart (epicardium) via the pericardium and facilitates the insertion of a guide wire in the pericardial space for further treatments. It employs a unique gripping element that utilizes the physiological differences between the pericardial tissue and the heart muscle tissue in order to access the pericardial space without puncturing the heart and monitor in real-time when the pericardial space is reached. Its clever design eliminates the risk of puncturing the heart or surrounding organs/vessels and creates a continuous workspace for additional treatments (ablation tools, pacemaker placement, etc.). It increases the physician’s confidence and provides safety and assurance to the patient.
The feasibility study served us to assess the technical, commercial and financial aspect to ensure market uptake; study IP protection and research our freedom to operate in the target market; and identify potential risks we may encounter during development, commercialisation and scale-up, as well as design mitigation measures.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

Bench, ex-vivo and tests on dead animals have already proved ViaOne’s safety and efficacy in gaining pericardial access without any apparent damage or bleeding from the heart. To obtain regulatory compliance in our target markets (initially Europe and the US) we need to perform a clinical study in humans, and we need to further improve the design and performance capabilities of our prototype. Before testing in humans we need to perform a validation and verification process and test it in a pre-clinical trial in living pigs. To cover all these tests, we will need to scale-up the manufacturing process to obtain at least 350 units of ViaOne.
The results of the clinical study with humans will be used to obtain regulatory approval (CE mark class IIb and FDA clearance), as well as for the commercialisation and dissemination of results.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

Current tools for pericardial access imply the use of a handheld needle against the heart. ViaOne is the first pericardial access tool that does not expose any sharp elements, eliminating the risk of puncture of the heart and surrounding organs. By reducing the risks to zero, we expect high levels of adoption in the cardiology and electrophysiology fields, making pericardial access safer and easily achievable in more hospitals, and such more patients can be treated in a minimally invasive way.

ViaOne is a needle-free exposure to access the pericardium

ViaOne´s unique handle