A patient in Cincinnati has become the first in the United States to receive an innovative system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
Vectorious Medical Technologies Ltd. developed a miniature pressure sensor that is implanted within the heart via standard minimally invasive transvenous catheterization. The sensor measures Left Atrial Pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status. The system supports a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients can better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly.
The first V-LAP implantation in the United States was performed by Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio. To date, 56 V-LAP implantations have been performed, resulting in more than 40,000 days of LAP monitoring. This study, together with the ongoing clinical program in Europe and Israel, will further inform an upcoming U.S. pivotal trial.
"The successful first U.S. V-LAP implantation represents a pivotal moment in heart failure management. By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalized treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalizations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care. The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward". Said Dr. Sitaramesh Emani.
Initial studies of the V-LAP system, which were recently published in the European Journal of Heart Failure, have shown promising results. During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, with no physician intervention, was sufficient to keep HF patients without congestion and within safe LAP ranges. This resulted in a significant decrease in the rate of HF-related hospitalizations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.
Eyal Orion, MD, co-founder and CEO of Vectorious, said, "We look forward to expanding our clinical activities in the U.S. 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 U.S. 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."
