Israeli medical technology firm Vectorious Medical Technologies has announced the first patient implantation in the US with its V-LAP left atrial pressure (LAP) sensor.
V-LAP sensor is a miniature pressure sensor inserted into the heart using standard minimally invasive transvenous catheterisation.
The sensor measures left atrial pressure, which is an indicator of fluid overload and congestion status, in heart failure (HF) patients remotely.
The system supports a scalable, physician-directed patient self-management approach, empowering heart failure patients to manage their condition.
According to Vectorious Medical, the V-LAP system allows patients to gain a deeper understanding of their disease. It also enables adjustments in diuretics, daily activities, and fluid volume as needed.
The first V-LAP implantation in the US was conducted by Sitaramesh Emani, director of heart failure clinical trials at Christ Hospital in Cincinnati, Ohio.
Vectorious Medical said that it has completed 56 V-LAP implantations, facilitating over 40,000 days of monitoring left atrial pressure.
The study, along with ongoing clinical programmes in Europe and Israel, will contribute valuable insights to an upcoming trial in the US.
Vectorious Medical co-founder and CEO Eyal Orion said: “We look forward to expanding our clinical activities in the US and work closely with physicians, nurses, FDA, and our partners towards a pivotal trial.
“Recent data published in JAMA Cardiology suggests recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the US between 1999 and 2021.
“I strongly believe that the technology and Treatment paradigm we develop have the potential to reverse this concerning trend, and our team is fully committed to this mission.”
The Israeli medical technology firm said that the initial studies of the V-LAP system have yielded promising findings.
Over a follow-up period encompassing 85% of the total duration, heart failure patients managed their condition independently without physician intervention using the V-LAP sensor.
The approach effectively maintained patients free from congestion and within safe LAP ranges, said the company.
