Multicenter Validation of the Novel Vivio® System for Non-Invasive Estimation of Elevated Left Ventricular End Diastolic Pressure
Multicenter Validation of the Novel Vivio® System for Non-Invasive Estimation of Elevated Left Ventricular End Diastolic Pressure
Findings presented at the 2023 American Heart Association Scientific Symposium
PASADENA, Calif., Nov. 13, 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.
More information on the AHA abstract and study is available here: https://www.ahajournals.org/doi/10.1161/circ.148.suppl_1.16544
About Ventric Health:
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/.
About MemorialCare Long Beach Medical Center:
MemorialCare Long Beach Medical Center is a member of MemorialCare, a not-for-profit, integrated health care system. Long Beach Medical Center has been providing the regional community with compassionate, quality health care for more than 100 years. While leading in specialized care, research and education, Long Beach Medical Center constantly re-invests itself to be on par with major academic institutions. Acquiring advanced technologies, along with specialists proficient and skilled with these technologies – give South Bay, Long Beach and Orange County residents access to the most minimally invasive procedures possible. With leading centers for cancer, heart, rehabilitation, orthopedics, neurology, research, and trauma, physicians and surrounding hospitals continually refer to Long Beach Medical Center and its accredited programs. For more information, visit memorialcare.org/LongBeach.
###
Media Contact
Janet Mordecai
Amendola Communications for Ventric Health