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 echocardiographic guidance, under local anesthesia.
“This technology will really change the way we manage patients with severe heart failure,” Sievert said in a prepared statement. “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.”
“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,” said Vectorious CEO and co-founder Oren Goldshtein. “This is very advanced technology that we hope will improve the future of chronic cardiac disease treatment.”
Investors in Vectorious include Fresenius Medical Care, Broadview Ventures, GoCapital, and China’s GEOC. The company has also received a $2.2 million grant from the European Union’s Horizon 2020 R&D program and the Israel Innovation Authority.