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.”
