Discover how the FDA-cleared Vivio System by Ventric Health is reshaping heart failure diagnosis and management. With advanced algorithms for noninvasive diagnosis, this innovative cardiac device brings timely interventions to home and outpatient settings. CEO Sean Brady discusses the technology, study results, and the potential of a hybrid care-at-home model. The Vivio System’s mobility, simplicity, and real-time results overcome barriers associated with social determinants of health. The study, presented at the 2023 American Heart Association Scientific Symposium, demonstrates the system’s efficacy, highlighting its potential to improve clinicians’ ability to diagnose heart failure in outpatient settings.
In a breakthrough for heart failure care, Ventric Health’s Vivio System, recently FDA-cleared, marks a paradigm shift in diagnosis and management. Developed by CEO Sean Brady and his team, this innovative cardiac device employs advanced algorithms to offer a noninvasive alternative to conventional methods. The Vivio System facilitates quick and efficient tests for elevated left ventricular end-diastolic pressure (LVEDP), transforming diagnosis from a time-consuming process to a five-minute endeavor. The technology’s mobility and real-time results not only streamline clinical workflows but also extend care beyond hospital walls, addressing social determinants of health barriers. In a recent interview with Ventric Health CEO and Co-founder Sean Brady, we delve into the technology, study results, and the potential impact of a hybrid care-at-home model on overcoming health barriers.
Q. Please describe your newly FDA-cleared cardiac device for heart failure and discuss how it works.
A. The Vivio System is designed to mitigate the impact of heart failure and delay its progression, empowering value-based care organizations to enhance clinical and health outcomes. It is the first medical device to enable noninvasive diagnosis of heart failure within clinical or home healthcare environments. Utilizing advanced algorithms, the system detects elevated left ventricular end-diastolic pressure (LVEDP) noninvasively, providing a simple yet sophisticated solution. The Vivio application, accessible on mobile tablets, facilitates a quick and easy test, delivering real-time results for clinicians.
Q. Your effort focuses on advanced algorithms for noninvasive diagnosis, enabling treatment in the home and outpatient settings that previously could only be done in the hospital. Please elaborate.
A. Vivio addresses the time-consuming and challenging nature of heart failure diagnosis. Traditional methods, such as echocardiograms, often require specialized equipment, technicians, and extended exam times. In contrast, Vivio’s adaptability across care settings, coupled with its real-time results, streamlines clinical workflows. Its mobility and ease of use make it an attractive alternative to invasive procedures, offering a patient-centric approach to care.
Q. What were the results of the study you did on the device results you presented at the 2023 American Heart Association Scientific Symposium?
A. In a pivotal study presented at the American Heart Association Scientific Symposium, the Vivio System demonstrated promising results. The study enrolled 728 patients across seven sites, utilizing a modified blood pressure cuff, Bluetooth-enabled ECG, and an algorithm for noninvasive diagnosis. Results showcased a sensitivity of 0.80 and specificity of 0.83, affirming the system’s potential to significantly improve clinicians’ ability to diagnose heart failure in outpatient settings.
Q. How can this technology and a hybrid care-at-home model help overcome social determinants of health barriers?
A. Vivio’s mobility and simplicity address barriers to diagnosis associated with social determinants of health. Trained clinicians can perform tests for elevated LVEDP in-home or clinical settings, overcoming transportation limitations. Real-time results facilitate immediate discussions between clinicians and patients, positively impacting healthcare literacy and patient understanding following a diagnosis.
Q. You suggest the device and the at-home care enable lower cost of care and improve patient experience – crucial for value-based care goals. How does technology achieve these goals?
A. Early diagnosis is crucial for managing heart failure effectively. Vivio’s ability to shift the point of diagnosis to more accessible locations, coupled with its ease of use, empowers at-risk organizations to reduce costs and improve outcomes through earlier interventions. By integrating smoothly into existing medical workflows, the technology supports a proactive approach to healthcare management, ultimately enhancing patient experiences and lowering overall healthcare expenditures related to heart failure.
Overall, the Vivio System emerges as a game-changer in the landscape of heart failure diagnosis and care. The study results, presented at the 2023 American Heart Association Scientific Symposium, underscore the system’s efficacy in noninvasive diagnosis, setting a new standard for outpatient settings. Its ability to overcome social determinants of health barriers, coupled with its cost-effective and patient-centric approach, positions Vivio as a catalyst for improved outcomes. By shifting the point of diagnosis upstream and empowering a hybrid care-at-home model, Ventric Health’s innovation not only enhances healthcare literacy but also signifies a crucial step toward reducing the economic burden of heart failure on the healthcare system.
