Trial of PADN device for PH with left heart disease opens in Europe
Pulnovo Medical reports two patients in Portugal doing well after procedure
A global clinical trial evaluating a pulmonary artery denervation (PADN) device in people with pulmonary hypertension (PH) associated with left heart disease has launched in Europe, with the first two patients enrolled at a hospital in Portugal, Pulnovo Medical, the device’s developer, announced.
These two adults have undergone the PADN procedure in the study, and are reported to be the first patients to receive the surgery outside of China, where Pulnovo Medical is based.
“PADN technology shows great potential in treating pulmonary hypertension associated with left heart disease,” Ruben Ramos, MD, the physician heading the team that performed the surgery at Centro Hospitalar Universitário de Lisboa Central-Hospital de Santa Marta, said in a company press release.
PADN is a surgical approach aiming to treat various forms of PH
“We are delighted to be the first in Europe to participate in this global clinical study,” Ramos added. “Our team is confident in this project and looks forward to bringing more treatment options to European pulmonary hypertension patients through this study.”
PH is characterized by unusually high pressure in the blood vessels of the lungs. Excessive blood vessel constriction, or narrowing, can contribute to this increased pressure.
In PH associated with left heart disease, problems on the left side of the heart, which normally receives oxygenated blood from the lungs and pumps it out to the body, cause pressure to build in surrounding blood vessels.
PADN is a surgical approach being explored for various forms of PH. The procedure aims to destroy nerves surrounding the pulmonary artery — the large vessel carrying blood from the heart to the lungs — that are involved in blood vessel constriction.
In doing so, PADN is expected to help lower pressure in the lungs’ blood vessels, slowing disease progression. Pulnovo’s PADN device includes a small tube, or catheter, that’s inserted into a large vein in the leg. It is connected to a machine that delivers radio waves to ablate, or destroy, the targeted nerve cells.
A previous Phase 2 trial called PADN-5 (NCT02220335) tested the surgical approach in people with combined pre- and post-capillary PH, a type of left heart disease-associated PH. Three-year data showed that PADN was associated with a lower risk of clinical worsening, gains in exercise capacity, and better heart function relative to a sham surgical procedure.
Phase 3 trial is underway in people with PH due to left heart disease
Pulnovo did not release details of the recently launched clinical trial. An ongoing Phase 3 study (NCT05824923) is testing the safety and efficacy of PADN in up to 264 people with PH associated with left heart failure, but its listed sites are all in China. Patients here are being randomly assigned to undergo PADN while continuing with their standard heart failure medications, or to continue only with their medications.
Its main goal is to evaluate patients for clinical worsening events over six months of follow-up.
The procedure went smoothly in the first two patients in Portugal, Pulnovo reported, with results considered to be “excellent.” The device also was reported to be easy to use.
“The PADN global multicenter clinical study is one of our key projects dedicated to innovative treatment technologies in the cardiovascular field,” said Jessie Lian, Pulnovo’s CEO.
A previous clinical study (NCT03282266) tested the PADN procedure in adults with pulmonary arterial hypertension. Results there also showed that PADN was associated with improved exercise capacity and a reduced risk of clinical worsening.
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