Analytics for Life and CorVista Health announced U.S. FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module. The CorVista System is an 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).
Diagnosing Pulmonary Hypertension
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 CorVista System with PH Add-On
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.
“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,” says 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.”
Further reading: Novel Blood Test Evaluates Severity in Pulmonary Arterial Hypertension
CorVista Clinical Validation Study
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, the company says. 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.
“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,” says 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.”
