Breakthrough Designated CorVista® System with Pulmonary Hypertension Add-On Cleared by FDA; Enabling Advanced Cardiovascular Testing at Point-of-Care

2024-04-05

临床结果

The Pulmonary Hypertension indication is the second FDA clearance for the CorVista System, amplifying its suite of diagnostic capabilities empowered by a proprietary algorithm derived from machine learning, to swiftly and accurately assess cardiovascular conditions at point-of-care The Pulmonary Hypertension (PH) Add-On will seamlessly integrate into the existing CorVista System currently marketed in the US which is designed to aid in the diagnosis of coronary artery disease (CAD) The addition of the PH Add-On to the CorVista System will expand clinicians' point-of-care diagnostic capabilities to more efficiently identify CAD and PH cardiovascular conditions which often present with overlapping symptoms TORONTO & BETHESDA, Md.--(BUSINESS WIRE)-- Analytics for Life, Inc. and CorVista Health Inc. announced the FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module. The CorVista® System is the first FDA-cleared, machine learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension (PH). This press release features multimedia. View the full release here: Pulmonary hypertension is a progressive disorder that affects the blood vessels in the lungs, causing the heart to work harder to deliver blood to the area. PH affects approximately 1% of the global population, and over half of patients with heart failure may be affected – the vast majority of whom (80%) live in areas with limited access to advanced cardiovascular medical and surgical care. Despite advances in diagnostic technologies, PH is still often difficult to diagnose due to overlapping symptoms with other heart and lung conditions. Limited early detection and existing treatment options have contributed to increasing mortality rates for people living with PH, highlighting the need for continued diagnostic innovation. The CorVista System with PH Add-On responds to this need, positioned to enable earlier diagnosis and better patient experiences in the detection and treatment of PH. The non-invasive CorVista System was recently cleared for use in evaluating the presence of significant coronary artery disease. In 2022 the FDA designated the CorVista System with PH Add-On as a Breakthrough Device for its potential to improve the diagnosis of PH. The breakthrough designation followed FDA’s review of a pilot performance study which demonstrated a reasonable expectation for the device to provide more effective diagnosis of PH in the standard of care. Results of the extensive clinical validation study supporting the market application (IDENTIFY PH) showed algorithm performance in identifying patients with elevated mPAP with sensitivity of 82% and specificity of 92% with a negative predictive value (NPV) of >99%. Introduction of the PH indication to the CorVista System will allow healthcare providers the ability to test symptomatic patients for multiple significant cardiovascular conditions in a single non-invasive procedure at the initial point-of-care. Having now successfully received market clearance, the CorVista System with PH Add-On joins a small cohort of under 100 breakthrough-designated devices to enter the US market. "As we continue to expand the CorVista System, we are proud to deliver meaningful advancements in diagnostics that support the earlier-stage detection of serious conditions, such as PH and CAD," said Ian Shadforth, Vice President and General Manager at CorVista Health. "Through CorVista, we are seeing how the power of machine learning can revolutionize care pathways, enabling earlier-stage detection and diagnosis, and ultimately empowering clinicians to deliver improved care and long-term outcomes." "Through the CorVista System, we have harnessed the potential of machine learning to develop our cutting-edge detection algorithms and deliver precise and reliable diagnostic tools,” said Jonathan Woodward, Chief Technology Officer and General Manager at Analytics for Life. “The Pulmonary Hypertension Add-On underscores our unwavering dedication to advancing novel solutions that make a tangible difference in patients' lives.” "I can't emphasize the importance of early diagnosis enough,” said Vallerie V McLaughlin, M.D. Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director Pulmonary Hypertension at the University of Michigan Ann Arbor and CorVista Health Medical Advisory Board member. “This technology has the potential to really improve the time from symptoms to diagnosis." Analytics For Life will continue to partner with CorVista Health to commercialize the CorVista System within the US. For more information regarding the CorVista System, please visit: About Pulmonary Hypertension Pulmonary hypertension is challenging to diagnose, affecting an estimated 1% of the world population and up to 10% of people greater than 65 years of age as well as 50% of patients with heart failure. The vast majority of those persons with this disorder (80%) live in areas with limited access to appropriate medical and surgical care. Pulmonary arterial hypertension is an aggressive disease resulting in right ventricular pressure/volume overload, right ventricular failure, and, in many cases, early death. About CorVista® System CorVista System is an Rx only, non-invasive point-of-care solution that is intended to synchronously collect and apply machine learning to a symptomatic 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 and PH Add-Ons has been cleared by FDA to market within the US. CorVista System is developed and manufactured by Analytics For Life, Inc. and licensed to CorVista Health, Inc. About Analytics For Life Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize point-of-care diagnostics . Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System®. The innovative CorVista System offers a non-invasive, point-of-care solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. Spearheading its introduction in the United States is our exclusive commercial partner, CorVista Health. For more information on Analytics For Life and the CorVista System, please visit: About CorVista Health CorVista Health, Inc. is applying machine learning to deliver novel cardiac disease detection algorithms using the proprietary CorVista System platform to transform cardiovascular care and the patient experience. CorVista Health is dedicated to enabling 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. For more information, visit: