Pulnovo’s PADN Device Yields Improved Outcomes in PAH Trial

Patients saw improved exercise capacity, blood flow dynamics, clinical outcomes

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with Pulnovo Medical‘s pulmonary artery denervation (PADN) device improved exercise capacity, blood flow dynamics, and clinical outcomes for pulmonary arterial hypertension (PAH) patients in a clinical trial called PADN-CFDA, the company announced.

“The PADN-CFDA results are very important because this was an adequately powered randomized controlled trial, and what we clearly saw was that there was lower rates of clinical worsening and a better satisfactory clinical response,” Gregg Stone, MD, a member of the Pulnovo’s scientific advisory board, said in a press release. Stone is chairman of the steering committee for an upcoming global clinical trial to test the PADN device.

Results from the trial were presented at this year’s Transcatheter Cardiovascular Therapy conference (TCT 2022). A study detailing the findings has been accepted for publication in JACC: Cardiovascular Interventions.

Pulnovo’s PADN device uses radio waves to block nerve activity around the pulmonary artery, the main blood vessel connecting the heart to the lungs. By blocking these nerves, blood pressure drops in the pulmonary artery, ultimately slowing disease progression. The device consists of a special looped catheter that’s inserted through a large blood vessel in the leg.

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The PADN-CFDA clinical trial (NCT03282266) enrolled 128 adults with PAH. Participants underwent either PADN treatment or a pretend procedure. All were also treated with a phosphodiesterase-5 inhibitor, which includes Revatio (sildenafil) and Adcirca (tadalafil).

The study’s main goal was to see if PADN could improve the distance participants could walk in six minutes (6MWD), a common measure of exercise capacity in ambulatory people.

Earlier data supported the PADN procedure’s potential in meeting this goal. Specifically, while 6MWD improved in both groups, the average improvement was significantly higher for patients given the PADN procedure compared with the pretend procedure: 56.9 m (187 feet) versus 26.7 m (88 feet), respectively. The group-corrected mean difference was 33.8 m (111 feet), favoring PADN.

The proportion of patients who saw any 6MWD improvement was higher in the PADN group compared to the pretend procedure group (81.4% vs. 61.5%).

Pulmonary vascular resistance (PVR), a measure of how difficult it is to pump blood through the lung’s blood vessels, decreased after six months in both groups, but the decrease was significantly larger in the PADN group compared to the pretend group (3 vs. 1.9 Wood units).

Measures of the function of the right ventricle (the part of the heart that pumps blood to the lungs) also favored the PADN group, as did levels of a marker of heart damage called NT-proBNP.

Satisfactory clinical response rates were higher in the PADN group (57.1% vs. 32.3%), while rates of clinical worsening were lower (1.6% vs. 313.8%).

Pulnovo said it successfully concluded talks about trial design with the U.S. Food and Drug Administration (FDA) earlier this year.