Periodic Reporting for period 2 - V-LAP (A revolutionary direct, daily heart monitoring platform for long-term tailored treatment of Heart Disease patients.)
Période du rapport: 2019-04-01 au 2020-03-31
Every year, millions throughout the world are diagnosed with heart failure (HF), a progressive disease requiring chronic management. Vectorious’ V-LAP, the world's first in-heart microcomputer, provides accurate measurements of heart function, allowing physicians to manage the disease effectively on a non-emergency basis, improving quality and length of life while minimizing hospitalizations.
Using cutting-edge technology, the V-LAP monitors the pressure in the heart's left atrium (LAP). This allows physicians to make informed decisions and to provide their patients with better treatment based on real-time clinical data and powerful AI algorithms. Vectorious' V-LAP empowers physicians by providing them with a practical solution for direct daily measurement of left atrial pressure. The real-time tracking method introduces remote heart failure care, whereby physicians can provide specific instructions, modify dosing regimens and make better decisions based on artificial intelligence (AI).
The V-LAP monitors the patient’s in-heart pressure on a daily basis. Daily monitoring with the Vectorious V-LAP takes only one minute, enabling physicians to curb heart failure progress by adjusting a medication regimen more precisely. Monitoring can take place anywhere, enabling the patient to maintain a normal life.
The V-LAP creates better clinical outcomes by achieving early detection, higher engagement, holistic monitoring and harnessing AI. The system offers the highest standard of treatment for patients through optimal treatment, self-management of the disease, quick procedure, and 24/7 remote monitoring.
Using cutting-edge technology, the V-LAP monitors the pressure in the heart's left atrium (LAP). This allows physicians to make informed decisions and to provide their patients with better treatment based on real-time clinical data and powerful AI algorithms. Vectorious' V-LAP empowers physicians by providing them with a practical solution for direct daily measurement of left atrial pressure. The real-time tracking method introduces remote heart failure care, whereby physicians can provide specific instructions, modify dosing regimens and make better decisions based on artificial intelligence (AI).
The V-LAP monitors the patient’s in-heart pressure on a daily basis. Daily monitoring with the Vectorious V-LAP takes only one minute, enabling physicians to curb heart failure progress by adjusting a medication regimen more precisely. Monitoring can take place anywhere, enabling the patient to maintain a normal life.
The V-LAP creates better clinical outcomes by achieving early detection, higher engagement, holistic monitoring and harnessing AI. The system offers the highest standard of treatment for patients through optimal treatment, self-management of the disease, quick procedure, and 24/7 remote monitoring.
Within the first period, Vectorious successfully optimised the V-LAP system including the implant, the wearable device, and the data display software. The company also installed assembly facilities in-house to enable production of the implants and initiated production for use in the clinical trials. In January 2019, Vectorious initiated the VECTOR-HF first-in-human (FIH) clinical trial, and performed the successful first “in-human” implantation of the V-LAP monitoring device. Implantation of the device in this first “in-human” trial was completed in just six minutes. It was fixated within the patient’s interatrial septum of the heart using a standard minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, with the application of local anaesthesia. By the end of the project, Vectorious successfully enrolled 13 patients in the trial across Germany, Italy, UK and Israel. The trial will continue after the project to ensure the collection of sufficient data for CE Marking.
William T Abraham (Ohio State University, Columbus, USA) commented: “The increase of left atrial pressure is the most specific and earliest sign of impending heart failure exacerbation—long before clinical symptoms occur. V-LAP’s unmet clinical need has been evident for years, and the cardiology profession will benefit greatly from the availability of technology that can provide this valuable indication non-invasively on a daily basis.”
Horst Sievert (CardioVascular Center Frankfurt, Germany), who performed the first implantation, stated: “This technology will really change the way we manage patients with severe heart failure. This is the first device that specifically enables us to monitor pressure within the left side of the heart – and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications and overall quality of life consistently and remotely.”
William T Abraham (Ohio State University, Columbus, USA) commented: “The increase of left atrial pressure is the most specific and earliest sign of impending heart failure exacerbation—long before clinical symptoms occur. V-LAP’s unmet clinical need has been evident for years, and the cardiology profession will benefit greatly from the availability of technology that can provide this valuable indication non-invasively on a daily basis.”
Horst Sievert (CardioVascular Center Frankfurt, Germany), who performed the first implantation, stated: “This technology will really change the way we manage patients with severe heart failure. This is the first device that specifically enables us to monitor pressure within the left side of the heart – and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications and overall quality of life consistently and remotely.”
Vectorious will continue the clinical trial, activating all sites and enrolling up to 30 patients in sites across Germany, Israel, Italy and the UK. The aim of the clinical trial is to assess the safety and performance of the V-LAP system in preparation for receiving the CE mark.
This project has enabled Vectorious to advance through the clinical trial and gain evidence for the CE marking and launch the V-LAP technology into the market. This project marks a major stepping stone in the development of the company, and for the development of the Heart Failure treatment market as a whole.
This project has enabled Vectorious to advance through the clinical trial and gain evidence for the CE marking and launch the V-LAP technology into the market. This project marks a major stepping stone in the development of the company, and for the development of the Heart Failure treatment market as a whole.