FDA Clears Noninvasive Test for Elevated Pulmonary Capillary Wedge Pressure

Heart failure affects an estimated 7.7 million U.S. adults and was the underlying cause of nearly 90,000 deaths in 2023, while heart failure with preserved ejection fraction remains frequently underdiagnosed. Elevated pulmonary capillary wedge pressure (PCWP) is a key indicator of both preserved- and reduced-ejection fraction heart failure and can help guide evaluation of patients presenting with dyspnea, chest pain, or fatigue. Clinicians therefore need rapid point-of-care tools to flag likely elevation without delay. A new add-on now provides a noninvasive test to indicate the likelihood of elevated PCWP at the point of care.

The CorVista System with Pulmonary Capillary Wedge Pressure (PCWP) Add-On has received U.S. Food and Drug Administration (FDA) clearance as an integrated, noninvasive test to indicate the likelihood of elevated PCWP. The PCWP Add-On represents the third FDA-cleared component of the CorVista point-of-care cardiopulmonary platform. It integrates with the existing system, which is marketed in the U.S. as an aid in diagnosis for pulmonary hypertension (PH) and coronary artery disease (CAD).

The CorVista System Capture device noninvasively records electrical and hemodynamic signals during a 3.5-minute resting acquisition. An artificial intelligence–based algorithm analyzes physiological signals from patients with no history of elevated PCWP or prior right heart catheterization who present with cardiovascular symptoms such as chest pain, dyspnea, and fatigue. The system provides a binary output indicating the likelihood of elevated PCWP for interpretation alongside clinical judgment, signs, symptoms, and patient history.

Regulatory milestones for the platform include FDA clearance for significant coronary artery disease in September 2023 and for elevated mean pulmonary arterial pressure associated with pulmonary hypertension in April 2024, with the elevated PCWP indication cleared in July 2026. The pulmonary hypertension indication received Breakthrough Device Designation in 2022. A Category III Current Procedural Terminology (CPT) code, 1104T, becomes effective January 1, 2027, to support reporting of augmentative algorithmic analysis using orthogonal voltage gradient and photoplethysmography signals across CAD, PH, and PCWP assessments.

“This FDA clearance is a testament to the dedication of our team to pushing the boundaries of cardiopulmonary diagnostics. By delivering a noninvasive assessment of PCWP, we can help patients with HFpEF, HFrEF and PH subtypes reach an earlier, more accurate diagnosis — and get to the appropriate treatment sooner. With this clearance, patients being evaluated for heart failure or pulmonary hypertension may avoid unnecessary invasive testing and benefit from faster, more confident care decisions and effective treatment,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health and Analytics For Life.

“For millions of people with suspected heart failure, the path to a clear answer is still too long — HFpEF, one of the most common forms, remains difficult to identify without invasive testing. With this clearance, the CorVista System supports assessment across conditions that account for up to 75% of people with symptomatic cardiovascular disease — advancing our mission to improve access to lifesaving care,” added Adrian Lam, President and Chief Executive Officer, CorVista Health.

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