November 15, 2023 — Ventric Health, a healthcare technology company and medical device provider focused on cardiovascular health, has announced data presented Saturday, November 11, at the American Heart Association (AHA) Scientific Symposium highlighting a pivotal study demonstrating validation of a noninvasive brachial cuff-ECG system for estimation of elevated left ventricular end diastolic pressure (LVEDP). The study outcomes were presented during the symposium's Exciting Developments in Heart Failure Diagnosis and Evaluation session.
The measurement of LVEDP is an established diagnostic method to evaluate all types of heart failure (HF), but it is invasive, requiring an in-hospital procedure that limits widespread accessibility. The Vivio System used in the study consists of a modified blood pressure cuff, a single-lead Bluetooth-enabled ECG, and an algorithm to identify patients with elevated LVEDP (>18mmHg) non-invasively.
In this multicenter, prospective U.S. study, 728 patients referred for left heart catheterization for routine clinical indications were enrolled. Measurements from a high-fidelity Millar catheter were compared with paired recordings from the Vivio® System. Data from the study met the efficacy endpoints, with the hold-out validation dataset showing a sensitivity of 0.80 [95% CI: 0.64 – 0.91] and a specificity of 0.83 [95% CI: 0.75 – 0.90].
"Data from this study provide the physician community with evidence that the Vivio® device plays an important role in improving the ability to accurately and non-invasively detect elevated LVEDP," said David M. Shavelle, MD, FACC, FASCAI, medical director, cardiology of MemorialCare Long Beach Medical Center and study principal investigator.
"These results highlight the vast potential of this novel technology to significantly improve clinicians' ability to diagnose HF in the outpatient clinic or home setting," said Derek Rinderknecht, Ph.D., Chief Technological Officer at Ventric Health. "We are pleased with the outcome of this work and look forward to positively impacting access in the communities that need it most through advancing health equity."
The Vivio System received FDA 510(k) clearance in October 2023.
For more information: www.ventrichealth.com
November 13, 2023 
