Ultrasound device for PH nets FDA breakthrough device designation
PreVail-PH2 study plans to enroll up to 30 adults with left-sided heart failure
The U.S. Food and Drug Administration (FDA) has granted breakthrough device status to the Gradient Denervation System, an ultrasound-based catheter for treating pulmonary hypertension (PH).
A breakthrough designation is given to medical devices that may offer significant advantages over existing treatments for irreversibly debilitating or life-threatening conditions. It’s intended to accelerate development and regulatory review so patients might access innovative therapies sooner.
“We are thrilled with this positive feedback from FDA. The granting of breakthrough device designation marks another important milestone for our pulmonary denervation clinical development program,” Martin Grasse, CEO of Gradient Denervation Technologies, said in a company press release.
In PH, abnormally high blood pressure in the pulmonary arteries forces the right side of the heart to work harder to pump blood through the lungs, which can lead to right heart enlargement and weakening over time.
Left heart failure, when the left side of the heart cannot pump blood as effectively as it should, is a frequent cause of PH. Normally, oxygen-poor blood flows from the right side of the heart to the lungs to receive oxygen, then returns to the left side to be pumped through the body. But when the left side is weakened, pressure builds up and backs up into the lungs and pulmonary arteries, causing PH.
As many as two-thirds of people with heart failure worldwide have increased pulmonary vascular resistance (PVR), a measure of how hard the heart has to work to push blood through the lungs, according to Gradient. High PVR is linked to increased risk of mortality and hospitalization.
Preventing pulmonary artery narrowing
There are no approved drug or device therapies in the U.S. for this subgroup of PH patients.
The Gradient Denervation System delivers therapeutic ultrasound energy to suppress sympathetic nerve activity that promotes the narrowing of the pulmonary arteries, which carry blood from the heart to the lungs. By lowering pulmonary blood pressure, the device should help ease PH symptoms. Sympathetic nerve activity plays a role in constricting blood vessels during stress.
The device is being evaluated in the PreVail-PH2 (NCT06052072) study, an early feasibility trial enrolling patients with PH due to left heart disease at multiple sites across the U.S.
The trial is designed to evaluate the safety and potential benefit of the Gradient Denervation System, and plans to enroll up to 30 adults, ages 22 to 85, who have left-sided heart failure and meet specific criteria, such as a mean pulmonary artery pressure (mPAP) greater than 20 mmHg and a PVR of at least 3 Wood units at rest.
The study’s main goal is to evaluate safety by assessing the rate of device- and procedure-related serious adverse events within 30 days after treatment. Changes in PVR will be measured six months after the procedure.
“We remain focused on completion of our early feasibility study as a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients,” Grasse said.
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