The first clinical data of an implantable heart sensor with remote measurement capacity was presented at the prestigious ESC Heart Failure 2022 Late-Breaking Science event
Israel-based Vectorious Medical Technologies announced the positive results from the VECTOR-HF I study of its V-LAP novel wireless system.
The first-in-man clinical study was intended to check the safety, ease of use, and accuracy of the V-LAP system, which is implanted permanently in the left atrial wall of the heart to remotely measure left atrial pressure (LAP).
According to the firm, the V-LAP system is the first device to directly assess pressure data generated from the left atrial, the most specific and complete indication for fluid buildup.
In the prospective, multisite, open label, single-arm study, the V-LAP intracardiac sensors were implanted in 30 patients with moderate to severe heart failure.
The results demonstrated that the implanting and placing the sensor in the intra-atrial wall are easy and safe operations. It also confirmed that the sensor sent correct LAP values.
Vectorious Medical Technologies co-founder and CEO Eyal Orion said: “The promising results of the VECTOR-HF I study are a major step in confirming our long-held belief that the V-LAP system is safe, durable, and accurate.
“Remote, real-time access to LAP changes is key to providing optimal treatment to heart failure patients and keeping these patients out of the hospital, living longer, better lives.
“Implanting a sensor in the heart is a challenging mission we took on ourselves a decade ago. Our results show that the V-LAP technology provides valuable long-term information from the patient’s heart, not just data.
“This will enable us to create a scalable platform to treat millions of heart failure patients and efficiently address a variety of comorbidities inside and outside the heart.”
Following the achievement of end points in VECTOR-HF I, the company has started patients in Europe for the VECTOR-HF II trial in January this year.
VECTOR-HF II’s findings will be incorporated into VECTOR-HF III, a larger pivotal study set to commence in the US in 2023 with the goal of obtaining FDA clearance.