Pulnovo, FDA Discuss Plans for Trial of PADN Device in PAH Patients
Pulnovo Medical reported that it “successfully concluded” a first meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a pivotal clinical trial of its pulmonary artery denervation (PADN) device in people with pulmonary arterial hypertension (PAH).
PADN aims to lower pulmonary artery pressure by targeting and blocking nerves — in this case, via focused radio waves — around the main pulmonary artery trunk and its bifurcation. The device consists of a special looped catheter that is inserted into a patient’s femoral vein, a large blood vessel in the thigh.
Lower pulmonary artery pressure is expected to delay disease progression.
“We consider this meeting one of the last few steps we needed to take before we formally file our application seeking the FDA’s approval for us to begin the PADN Global Clinical Trial,” Cynthia Chen, Pulnovo’s chief strategy officer, said in a press release.
“Numerous key opinion leaders, including well-respected cardiologists and pulmonary hypertension physicians across the United States and Europe, have expressed strong interest in participating in the PADN Global Clinical Trial and serving on the trial’s Steering Committee,” Chen added.
Global trial planned of device as PAH treatment
In its pre-submission FDA meeting, Pulnovo discussed the design of the planned PADN global trial, including measures to evaluate the device’s safety and effectiveness, as well as criteria for patient selection, biocompatibility (device properties that make it compatible with living tissue), and planned statistical analyses. Both preclinical and clinical data, including long-term efficacy studies in over 400 people, were also presented.
Trial design is expected to be similar to the PADN-CFDA clinical trial (NCT03282266) in China, which compared the safety and efficacy of Pulnovo’s device to that of a sham operation in 128 adults with PAH.
The PADN-CFDA study that concluded in 2021 reached its main efficacy goal, that of a significant improvement in patients’ exercise capacity from the study’s start as assessed in the six-minute walk distance test, Pulnovo reported.
Patients also experienced significant improvements across other measures of physical function, as well as in blood flow dynamics. No device-related adverse events were reported.
“Over a decade of clinical evidence provides to FDA an excellent roadmap for what we hope will be a successful pivotal trial and we look forward to filing our IDE [investigational device exemption] application and working with the FDA to obtain IDE approval to begin patient enrollment,” said Jessie Lian, Pulnovo’s CEO.
“We will provide periodic updates … related to the proposed global trial as Pulnovo progresses through the IDE approval process,” Lian added.
Pulnovo’s PADN device has been designated a breakthrough device by the FDA, a status that facilitates communication with the agency and grants manufacturers prioritized review of a submission.
“We are leveraging an accelerated regulatory pathway that is enabled by our FDA Breakthrough Device Designation. This first Pre-Sub meeting with the FDA allowed us to showcase our technological and clinical strengths,” Chen said.
Shaoliang Chen, chair of Pulnovo’s scientific advisory board, and Gregg W. Stone, steering committee chair for the PADN Global Trial and an advisory board member, also took part in the FDA pre-submission meeting.