Vectorious Medical Technologies has announced the initiation of the VECTOR-HF first-in-human (FIH) clinical trial, and the successful first “in-human” implantation of the V-LAPTM monitoring device. A press release reports that the trial will enrol up to 30 patients six European sites across Germany, Israel, Italy and the UK. It adds that VECTOR-HF is a prospective, multicentre, single-arm, clinical trial designed to assess the safety and performance of the V-LAP system in preparation for receiving the CE mark.
According to the press release, V-LAPTM sensory device is the world’s first 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 actionable 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 daily at home via an easy, non-invasive method using a small, portable external unit.
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
William T Abraham (Ohio State University, Columbus, USA) comments: “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, states: “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.”
The press release states that the V-LAP system was designed and developed by Vectorious Medical Technology to provide better treatment for heart failure. It is a simple, minimally-invasive device implanted into the left atrial to monitor pressure, enabling easy-to-access data through a Cloud-based system. The Vectorious system intend to increase chronic heart failure patient quality of life and reduces readmission rates. With its user-friendly external home-unit, physicians can get daily ‘push button’ readings of patient haemodynamic pressure to provide early, accurate physiological indication of cardiac decompensation. This not only helps physicians save lives and cut healthcare and hospital costs, but also enables patients to enjoy ongoing, personalised care with an improved quality of life.