CorVista System with PH Add-On

The CorVista® System with PH Add-On is a non-invasive diagnostic aid that employs a machine learning algorithm to analyze synchronously acquired cardiac electrical (VCG) and hemodynamic (PPG) signals, along with patient demographics, to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure. This system is intended for use by healthcare providers to assist in the evaluation of adult patients presenting with cardiovascular symptoms suggestive of pulmonary hypertension, complementing their overall clinical assessment.

The CorVista® System with PH Add-On is a non-invasive medical device system comprising hardware (including a Seven-Channel Lead Set, PPG Sensor, and a Capture Device/Tablet) and software components, designed to aid healthcare providers in assessing patients with cardiovascular symptoms for the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. The system functions by synchronously acquiring cardiac electrical signals through vectorcardiography (VCG) and hemodynamic signals via photoplethysmography (PPG). These physiological signals, along with patient demographics, are analyzed by a proprietary machine learning-based algorithm within the PH Add-On module, which then generates a binary output. This output is presented to the healthcare provider via a tablet, mobile app, or a secure web-based portal, serving as an adjunctive tool to be used in conjunction with clinical judgment, patient signs, symptoms, and history. The clinical performance of the CorVista System with PH Add-On was evaluated in a prospective, multicenter study involving 386 symptomatic adult subjects. The device's output was compared against established clinical outcomes: elevated mPAP (≥ 25mmHg confirmed by invasive right heart catheterization) for sensitivity testing, and non-elevated mPAP (determined by core lab adjudicated Transthoracic Echocardiogram) for specificity testing. The study demonstrated 82% sensitivity and 92% specificity, with a negative predictive value (NPV) greater than 99% and an area under the receiver operating characteristic curve (AUC-ROC) of 0.95. A secondary endpoint analysis at an mPAP threshold of ≥ 21 mmHg showed an AUC-ROC of 0.93 and 78% sensitivity. Additional studies confirmed the repeatability and reproducibility of the PH score generated by the system.

AI Regulatory Concerns

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• Q1. What is the performance of the CorVista System with PH Add-On in diverse patient populations, particularly those with comorbidities that might also present with similar cardiovascular symptoms (e.g., COPD, left heart disease)?; How does the algorithm's reliance on patient demographics influence its predictive accuracy, and are there specific demographic profiles where its performance varies significantly?; Can the system provide a continuous or multi-level likelihood score rather than a binary output, potentially offering more nuanced information for clinical decision-making?; What are the specific VCG and PPG features identified by the machine learning algorithm as most indicative of elevated mean pulmonary arterial pressure?; How was the core lab adjudication of Transthoracic Echocardiograms (TTE) standardized to ensure consistency in determining non-elevated mPAP for the specificity analysis, and what was the inter-observer variability?