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

Project Information

V-LAP

Grant agreement ID: 774831

DOI

10.3030/774831

Project closed

EC signature date 15 May 2017

Start date 1 May 2017

End date 30 September 2017

Funded under

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

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

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.)

Reporting period: 2017-05-01 to 2017-09-30

Summary of the context and overall objectives of the project

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.

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

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.

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)

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