WASHINGTON–(BUSINESS WIRE)–#ML—CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.
The CorVista® System is a non-invasive medical device system comprised of hardware and software components that are designed to work together to allow a physician to evaluate the patient at point-of-care for cardiac disease using a static machine-learned detection algorithm. The CAD Add-On is the first of the company’s anticipated suite of cardiac detection algorithms to receive market clearance.
“From all of us at CorVista Health, we are thrilled to announce we have obtained FDA clearance of the CorVista System,” said Don Crawford, President and CEO of CorVista Health. “Our point-of-care, non-invasive solution rules out significant CAD with a negative predictive value (NPV) of 99%. Furthermore, it requires no fasting, radiation, or significant capital investment. The ability to obtain a result within minutes will be a game changer in aiding physicians to detect the potential presence of cardiac disease.”
The CorVista System is indicated to analyze sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.
The clearance was based on an extensive blinded clinical validation dataset (N=1,816), collected through the IDENTIFY study, showing performance in identifying significant CAD with sensitivity of 88% and specificity of 51%. These results are comparable to the rule out performance of coronary computed tomography angiography (CCTA)1. Additionally, this performance is maintained in the currently underserved female population. This milestone follows the announcement of receiving FDA Breakthrough Designation for the company’s second disease specific Add-On module in development focused on pulmonary hypertension.
“We believe CorVista Health has the ability to transform the way cardiovascular disease is diagnosed, particularly in underserved low-resource settings where there is the greatest need,” said Charles Bridges, M.D., ScD., Executive Vice President, Chief Scientific Officer of CorVista Health. “CorVista Health’s innovative solution has the potential to make a tremendous impact to our healthcare system and enable more equitable care.”
1. Knuuti, Ballo, et al; (2018) The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability, European Heart Journal, Volume 39, Issue 35, 14 September 2018, Pages 3322–3330, https://doi.org/10.1093/eurheartj/ehy267
About CorVista® Health
CorVista Health, Inc. is applying machine learning to develop novel cardiac detection algorithms to enhance the CorVista System platform over time, with the aim of transforming cardiovascular care and the patient experience. For more information, visit corvista.com. CorVista Health is dedicated to addressing the FDA’s call to action for leveraging health technologies to advance health equity, as presented by FDA Commissioner, Dr. Robert Califf. Particularly, the decline in life expectancy in rural areas has been cited as key evidence of disparate health outcomes. CorVista System has the potential to enable more equitable care by providing access to immediately actionable, high-quality cardiovascular status results in low-resource settings, where access to capital-intensive equipment and the qualified specialists needed to operate them may not be available. In this way, the CorVista System is uniquely positioned to advance the quality of care in rural and low-resource settings.
About CorVista® System
CorVista System is a non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a patient’s cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting or exercise. Within minutes of the test, the CorVista® Analysis is available in a secure web portal to aid physicians in rapidly diagnosing and treating patients with suspected cardiovascular disease, answering important clinical questions to guide better treatment decisions. The CorVista® System with CAD add-on has been cleared to market as a 510(k) device. Additional CorVista System Add-ons for Pulmonary Hypertension and LV Filling Pressure are currently investigational devices limited by federal law (or United States) law to investigational use and are not available for commercial distribution.
Chris Bing Ernst