Vectorious Medical Technologies Ltd., an innovator in implantable hemodynamic monitoring in heart failure (HF), today announced results of VECTOR-HF I, a first-in-man clinical study demonstrating the robust safety, ease of use, and accuracy of its pioneering V-LAP novel wireless system. The V-LAP system is implanted permanently in the left atrial wall of the heart to remotely calculate left atrial pressure (LAP).
The VECTOR-HF I data was presented on May 22 during a prestigious late-breaking science forum at the European Society of Cardiology (ESC) Heart Failure 2022 and is the first clinical data from this study to be made public. Late-breaking sessions highlight the most innovative and promising advances in heart failure research and offer special recognition for studies likely to have a significant impact on clinical care of patients.
The V-LAP system is the first device to directly measure pressure data generated from the left atrium, the most specific and comprehensive indication for fluid accumulation and the culmination of a decade of work by Vectorious Medical Technologies. By enabling physicians to have direct access to LA pressure readings remotely, heart failure treatment has the potential to be more personalized, accurate and timely, beginning even before physiological symptoms appear.
In this prospective, multisite, open label, single-arm study, V-LAP intracardiac sensors were implanted in 30 patients with moderate to severe HF. The study showed that implantation and positioning of the sensor in the intra-atrial wall are simple-to-master and safe procedures. Further, it confirmed that the sensor transmitted accurate LAP measurements, as measured at 3 months post procedure and compared to pulmonary capillary wedge pressure (PCWP) data.
The VECTOR-HF I study also provided early indications of clinical benefit of direct LAP measurement, based on improvement in well-established quality-of-life metrics.
Eyal Orion, Co-founder and CEO, Vectorious Medical Technologies: “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.”
Professor Filippo Crea, Director of the Department of Cardiovascular and Pneumological Sciences of the University Hospital Agostino Gemelli in Rome and a principal investigator for the VECTOR-HF studies: “The increase of left atrial pressure is a specific and early sign of impending heart failure exacerbation – long before clinical symptoms occur. Its non-invasive monitoring might substantially improve the management of patients with chronic heart failure. Although the VECTOR-HF I trial was not powered to evaluate efficacy or impact on patient outcomes, preliminary data demonstrated how early diuretics change, based on increased LA pressure, helps to stabilize patients.”
Given the success of VECTOR-HF I in meeting its endpoints, a second prospective, multi-center study, VECTOR-HF II, started enrolling patients in Europe in January 2022, with goals of achieving a cohort of 20 patients. This ongoing study aims to assess a patient app that is designed as part of the V-LAP system to enable heart failure patients to take an active role in managing their disease for the first time.
Lessons learned from VECTOR-HF II will be incorporated into VECTOR-HF III, a larger pivotal study which is scheduled to begin in the US in 2023 with the goal of achieving FDA approval.