Saving millions of lives by enabling an effective treatment for Heart Failure patients; V-LAP, a revolutionary, miniaturized implant and its dedicated wearable device.

Informazioni relative al progetto

V-LAP

ID dell’accordo di sovvenzione: 774831

DOI

10.3030/774831

Progetto chiuso

Data della firma CE 15 Maggio 2017

Data di avvio 1 Maggio 2017

Data di completamento 30 Settembre 2017

Finanziato da

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

VECTORIOUS MEDICAL TECHNOLOGIES LTD
Israel

Periodic Reporting for period 1 - V-LAP (Saving millions of lives by enabling an effective treatment for Heart Failure patients; V-LAP, a revolutionary, miniaturized implant and its dedicated wearable device.)

Periodo di rendicontazione: 2017-05-01 al 2017-09-30

Sintesi del contesto e degli obiettivi generali del progetto

Heart Failure (HF) is a life-threatening chronic condition affecting 26 million people worldwide, in which inefficient heart pumping causes body fluid retention, impacting patients’ quality of life with shortness of breath, fatigue, insomnia, leg swelling among other symptoms. There is still no physiological indicator for increase in body fluid retention and the patient remains asymptomatic for weeks until a sudden, life-threatening condition, Acute Decompensate Heart Failure, arises, resulting in immediate hospitalization. The filling pressure of the left chambers of the heart (Left Atrium Pressure, LAP) increases gradually throughout the process, and is the earliest, most objective marker way to detect ADHF. Vectorious has developed the V-LAP system, the world’s first miniature implant for left-atrial monitoring. The system includes a simple, minimally-invasive implanted device, easy-to-access data and user-friendly wearable device. The V-LAP system helps physicians to help patients help themselves and both reduces hospitalisation and increases CHF patient quality of life. The system has been through preclinical development and is now ready to finalise the engineering of the wearable device and upgrade the software before advancing to clinical testing. The clinical validation will include 20 patients and anticipated to be held in Germany, Italy and the UK.

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

Vectorious undertook a full analysis of both the technical and business potential of the V-LAP system. Vectorious reviewed results from the preclinical studies and identified the system components that require additional optimisation. Vectorious reviewed results from the preclinical trials and defined the product development plan to achieve clinical validation. Vectorious also explored in detail regulatory requirements, and defined the commercialisation strategy accordingly. Vectorious also scouted and initiated discussions with various key stakeholders including hospitals, CROs, suppliers etc.

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)

The expected outcome of the project is to successfully execute the clinical trial and demonstrate the safety and performance of the V-LAP system. The results will be used to apply for the CE Mark certification and enable commercialisation in Europe. The V-LAP development will boost economic growth and create jobs within Vectorious and indirectly with medical device distributors, manufacturers and component suppliers.

V-LAP implant