FDA clears noninvasive tool to spot heart failure in PH patients

The U.S. Food and Drug Administration (FDA) has cleared a noninvasive add-on feature for a test that detects heart patterns in people with pulmonary hypertension (PH).

The new tool in the Corvista-PH test estimates the likelihood of elevated pulmonary capillary wedge pressure (PCWP), a key marker of heart failure.

The add-on feature, from Corvista Health and Analytics For Life, analyzes signals collected during a brief resting test, offering doctors an alternative to invasive right heart catheterization in patients with symptoms such as chest pain, shortness of breath (dyspnea), or fatigue.

“This FDA clearance is a testament to the dedication of our team to pushing the boundaries of cardiopulmonary diagnostics,” Charles R. Bridges, MD, executive vice president and chief scientific officer of Corvista Health, said in a company press release. “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.”

PH is a group of progressive diseases characterized by elevated pressure in the pulmonary arteries, the blood vessels that carry blood through the lungs. This means the heart must work harder to pump blood, which leads to heart strain or right heart failure.

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System uses AI to identify disease patterns

The Corvista-PH test, part of the Corvista System, detects patterns in blood flow and the heart’s electrical activity. These patterns are analyzed using machine learning, a type of artificial intelligence that uses computer algorithms trained on large datasets to identify disease-associated patterns.

The test is done in a doctor’s office, and it does not involve injections, fasting, radiation, exercise, or contrast dyes that make internal structures more visible on imaging scans.

In 2024, the FDA cleared the Corvista System to help detect PH, supported by data from two clinical studies: IDENTIFY-PH (NCT04031989) and IDENTIFY (NCT03864081). The system is also cleared to help detect coronary artery disease (CAD), a common heart condition caused by atherosclerosis (plaque buildup), leading to chest pain (angina) and heart attack.

Elevated PCWP reflects the pressure inside the left side of the heart. When this pressure is too high, it’s a sign of heart failure — either heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF). Ejection fraction refers to the percentage of blood pumped out of the heart with each heartbeat.

Traditionally, PCWP has been measured through right heart catheterization. In this invasive procedure, a doctor threads a thin, flexible tube through a vein in the neck, groin, or arm into the right side of the heart to directly measure pulmonary artery pressure.

HFpEF makes up about half of all heart failure cases but is often underdiagnosed, which can delay treatment and raise costs for patients and the healthcare system.

The add-on feature of the Corvista System operates via a device called Capture, which collects electrical and blood-flow signals during a resting session lasting about 3.5 minutes. The system then processes these signals and produces a binary (yes-or-no) result indicating the likelihood of elevated PCWP.

The test is designed for healthcare providers to use alongside their own clinical judgment and the patient’s symptoms and history, rather than as a stand-alone diagnosis.

“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,” Bridges said.

In 2022, the system received FDA breakthrough device designation, a status meant to speed development and review of certain medical devices, for PH. A new U..S. billing code is set to take effect Jan. 1, 1017, supporting billing for use of the Corvista System across PH, CAD, and PCWP assessments.

The company is also collaborating with Mayo Clinic to evaluate whether the Corvista-PH test, used alongside standard diagnostic procedures, can improve the detection, risk stratification, and referral accuracy for people with suspected PH.

Adrian Lam, president and CEO of Corvista Health, said the system now “supports assessment across conditions that account for up to 75% of people with symptomatic cardiovascular disease.”