TEL
AVIV, Israel, July 16,
2024 /PRNewswire/ -- 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."
About Vectorious Medical Technologies Ltd.
Vectorious is a Tel
Aviv-based, privately held company, founded in 2011. The
company's V-LAP System enables heart failure patients to better
control their disease by remotely monitoring the heart's Left
Atrial Pressure (LAP) and detecting fluid accumulation in the
earliest stages of the disease, prior to physiological symptoms. A
patient app further empowers the patient to self-titrate medication
in real-time based on data extracted from the heart. For more
information, please visit the company website.
Contact:
Lili Arbely-Elbaz
Vectorious Medical Technologies.
+972-(0)525909192
lili@vectoriousmedtech.com
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SOURCE Vectorious Medical Technologies Ltd.