1st U.S. Implant of Vectorious’ V-LAP Left Atrial Pressure Sensor

Vectorious Medical Technologies has achieved the first U.S. patient implanted with its V-LAP left atrial pressure (LAP) sensor.

The first V-LAP implantation procedure was performed by Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio.

The sensor measures LAP, which is the earliest and most accurate indicator of fluid overload and congestion status in the heart. Vectorious said the system supports a scalable, physician-directed patient self-management strategy. This means heart failure patients can take an active role in their disease’s management.

The Tel Aviv, Israel-based company said using V-LAP can help patients better understand their disease and adjust diuretics, daily activities, and fluid volume.

Initial V-LAP system studies were published in the European Journal of Heart Failure last month.During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, without physician intervention, was enough to keep heart failure patients without congestion and within safe LAP ranges.

This resulted in a significant decrease in the rate of heart failure-related hospitalizations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.

To date, 56 V-LAP implantations have been performed, resulting in over 40,000 days of LAP monitoring. This study, together with an ongoing clinical program in Europe and Israel, will further inform an upcoming U.S. pivotal trial.

“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,” said Vectorious co-founder and CEO Eyal Orion, MD. “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.”