Ventric Health Receives FDA 510(k) Clearance for Vivio®

Non-invasive medical device developed to quickly deliver the cardiovascular insights value-based care organizations need to reduce costs and improve patient lives

PASADENA, Calif., Oct. 25, 2023 /PRNewswire/ -- Ventric Health, a healthcare technology company and medical device provider focused on cardiovascular health, today announced that its medical device, the Vivio System™, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). As a result, Vivio empowers clinicians to non-invasively diagnose heart failure within clinical and home health care environments. 

Heart failure affects approximately 6.5 million people in the U.S., with an additional 550,000 newly diagnosed each year. It is defined as the result of the heart not pumping enough blood to meet the body's needs or doing so only at the expense of elevated filling pressure, also known as elevated left ventricular end diastolic pressure (LVEDP).^1,2 Ventric Health's Vivio System is a mobile, tech-enabled device aiding in heart failure diagnosis that is unmatched in the industry. Simple to use but sophisticated in function, Vivio uses advanced algorithms to quickly detect elevated LVEDP non-invasively.

"Up to 50% of heart failure patients are undiagnosed, and diagnosis can lag up to 30 months following the initial onset of symptoms," said Sean Brady, co-founder and CEO at Ventric Health. "Early diagnosis is crucial for treating and managing heart failure in our most vulnerable populations, those that are 65 years or older. Now with the introduction of Vivio, clinicians can detect the gold standard measurement of heart failure, elevated LVEDP, in less than five minutes––and can do so in any care setting."

Vivio represents a unique quantum step forward in enabling the diagnosis of this costly and deadly condition within Medicare populations. Because of the lag in diagnosis, clinical research has shown 65% of Medicare patients are first diagnosed with heart failure in the ER or inpatient setting, and this number increases to 75% for patients with lower socioeconomic status. The economic impact of heart failure is profound –– making early detection and diagnosis even more critical. Heart failure is predicted to account for $70 billion of U.S. healthcare expenditures by 2030.

Ventric Health co-founder Mory Gharib emphasized, "This is an indispensable clinical insight for clinicians in any care setting. It fortifies our commitment to provide transformational clinical interventions in cardiovascular health, enabling clinicians and value-based care organizations to expand the site of care for diagnoses, grow the number of patients that can be reached, and change the timeline for treatment."

An innovative aid in heart failure diagnosis, Vivio is designed to reduce the impact of heart failure and delay its progression, allowing for value-based care organizations to improve clinical and health outcomes. Its mobility and simplicity help overcome social determinants of health (SDOH) barriers to diagnosis, like transportation limitations, by enabling trained clinicians to test for elevated LVEDP in the home or in the clinic.

Beneficial for both patients and clinicians, Vivio is designed for mobility and ease-of-use, making it an attractive alternative choice of traditional methods like catheterization or echocardiograms. Its adaptability across care settings and real-time results elevates clinical workflow efficiency while enabling patient-centric care. A recent survey of patients showcased that all respondents found the Vivio test easy to have clinicians perform on them and 95% preferred it to receiving an echocardiogram.

To learn more about Vivio and how Ventric Health is driving the tech-enabled revolution in detecting heart failure, visit the Vivio resource page.

About Ventric

Ventric Health is a healthcare technology company and medical device provider transforming clinical interventions in cardiovascular health. We are the first and only company to enable non-invasive diagnosis of heart failure within a clinical and home health care environment, which has reshaped the diagnostic pathway for at-risk populations and set a new standard for the industry. Through our academic origins, we were able to capture unprecedented scientific data on the human heart and, today, are using that insight to develop a suite of innovations that reduces the impact of cardiovascular disease, enabling value-based care organizations and healthcare teams to lower costs and improve patient lives. To learn more visit https://www.ventrichealth.com/.

Sources:

1. Braunwald E. Heart Disease: A Textbook of Cardiovascular Medicine. 4th edition. Philadelphia: W.B. Saunders, 1992.
2. Leon-Chisen, Nelly. ICD-10-CM and ICD-10-PCS Coding Handbook, with Answers 2023. HEALTH FORUM, 2023

Media Contact
Janet Mordecai
Amendola Communications for Ventric Health
[email protected]

SOURCE Ventric Health