Vectorious starts trial of implantable wireless heart monitor

Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device. Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. The prospective, multicenter, single-arm clinical trial was designed to assess the safety and performance of the V-LAP system in preparation for receiving the CE Mark. Vectorious said its V-LAP sensory device is the world’s first digital, wireless, battery-less device that can communicate from deep within the body using high-resolution waveform morphology. Because the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, company officials believe the feedback provided by the V-LAP will enable a significant improvement in heart failure management. Patients implanted with the V-LAP will be able to measure left atrial pressure at home via a non-invasive method using a small, portable, external unit. Horst Sievert, M.D., director of the CardioVascular Center in Frankfurt, Germany, performed the first implantation, completing it in just six minutes, the company said. Sievert fixated V-LAP within the interatrial septum of the patient’s heart using a standard, minimally-invasive percutaneous procedure under fluoroscopy and echocar...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Cardiac Assist Devices Cardiac Implants Clinical Trials Featured News Well Patient Monitoring Research & Development Vectorious Medical Technologies Source Type: news