Gradient’s PH ultrasound device accepted into FDA’s TAP program
Pilot advisory program to help accelerate development of medical devices
The U.S. Food and Drug Administration (FDA) has accepted Gradient Denervation Technologies, a company that makes an ultrasound-based catheter to treat pulmonary hypertension (PH), into a program to facilitate development of medical devices.
Acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot will give the company more opportunities to interact with regulatory authorities. It comes after the company’s Gradient Denervation System was granted breakthrough device designation by the FDA. Through TAP, Gradient will also be able to strategize with providers, associations, and patient organizations.
Streamlining collaboration with FDA
“We’re excited to be included in the TAP Pilot as the program will help streamline collaboration with FDA — from initiating our pivotal clinical study to accelerating access to this breakthrough therapy upon approval,” Martin Grasse, Gradient’s CEO, said in a company press release.
PH is characterized by high blood pressure in the pulmonary arteries, which carry oxygen-poor blood from the right side of the heart to the lungs. Failure of the left side of the heart, which pumps oxygen-rich blood to the body, may cause PH. If the left side weakens, circulation may back up, increasing pulmonary artery pressure. The right side of the heart then needs to work harder to pump blood to the lungs, which may cause additional strain.
The World Health Organization categorizes PH caused by left heart failure as group 2 PH. “There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, which reinforces the need to expedite access to new innovative therapies,” Grasse said.
Gradient designed its device to treat people with group 2 PH. With a minimally invasive procedure, the device delivers therapeutic ultrasound waves to suppress the nerve activity that promotes narrowing of the arteries around the pulmonary artery. This is expected to decrease resistance to blood flow and lower blood pressure, according to Gradient.
Currently, the company is evaluating the device in the PreVail-PH2 clinical trial (NCT06052072). The study will document side effects of the device and measure change in pulmonary vascular resistance (PVR), a metric of how difficult it is for the heart to pump blood to the lungs.
PreVail-PH2 will enroll approximately 30 people, ages 22 to 85, with group 2 PH. Participants need to meet minimum criteria for PVR and pulmonary artery pressure. Adults who meet these criteria may be eligible to enroll at sites in the U.S.
Gradient’s recently announced breakthrough status was granted based on its potential to treat an irreversibly debilitating or life-threatening condition. The designation helps speed up the regulatory review process to enable earlier access.
TAP has 75 devices enrolled across five divisions and offices of the FDA. Gradient hopes to leverage its acceptance in the program to increase treatment options for people with group 2 PH.
“We expect that guidance from TAP Pilot advisors will be immensely valuable in developing a targeted therapy intended to improve outcomes and quality of life for these underserved patients,” Grasse said.
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