A medical device for patients with heart failure is part of a first-in-human (FIH) clinical trial, Vectorious Medical Technologies has announced.
The trial uses the V-LAP monitoring device and will enrol up to 30 patients in six cities across Germany, Israel, Italy and the UK as its safety is assessed ahead of the device receiving its CE Mark.
V-LAP is a digital, wireless, battery-less device that is able to communicate from deep within the body using high-resolution waveform morphology. Since the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, the feedback provided by the V-LAP will enable a significant improvement in ongoing management of heart failure patients. Once patients are implanted with the V-LAP, they will be able to measure left atrial pressure (LAP) daily at home via a non-invasive method using a portable external unit.
Implantation sees the device 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 anaesthetic.
Professor Horst Sievert, director of the CardioVascular Center Frankfurt, who performed the first implantation, said: “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.”
Left atrial pressure has been scientifically established as the most specific physiological indication for heart failure exacerbation. Approximately 90% of patients admitted to the hospital for heart failure have pulmonary congestion related to elevated left atrial filling pressure (LAP). The increase of LAP is the earliest sign of impending heart failure exacerbation – long before clinical symptoms occur.
Oren Goldshtein, chief executive officer and co-founder of Vectorious said: “Implanting our first patient in the VECTOR-HF trial is a significant achievement that moves us closer to our goal of enabling optimal management for heart failure patients. This is very advanced technology that we hope will improve the future of chronic cardiac disease treatment.”
The V-LAP system was designed and developed by Vectorious Medical Technology to provide better treatment for heart failure.