Treatment starts in trial of system for form of severe emphysema
First emphysema patient with collateral ventilation begins using AeriSeal System
A first patient has been treated in a pivotal clinical trial of Pulmonx’s AeriSeal System, testing its ability to limit collateral ventilation in people with severe emphysema, a form of chronic obstructive pulmonary disease (COPD).
These patients currently are precluded from using the company’s minimally invasive Zephyr Endobronchial Valve, a medical device approved in the U.S. for people with severe emphysema who have difficulty breathing.
It has been shown that Zephyr Valve use can lead to sustained improvements in lung function, exercise capacity, and quality of life in people with homogeneous emphysema, meaning those with no major differences between regions of the lung.
Collateral ventilation refers to ventilation of the lung’s tiny air sacs through pathways that bypass normal airways. It is caused by openings in the lung fissures, or walls between the lung’s lobes.
Goal is to stop collateral ventilation, so patients can move to Zephyr Valve
The CONVERT II trial (NCT06035120) is recruiting up to 200 adults, ages 22-80, with heterogeneous emphysema and collateral ventilation across 30 sites in the U.S., Australia, and Europe. Collateral ventilation will be assessed with Pulmonx’s Chartis pulmonary assessment system.
Its main goal is to assess the safety and effectiveness of the AeriSeal System in closing collateral ventilation, and allowing more patients to use the Zephyr Valve. Lung volume reduction, lung function, quality of life, and exercise capacity also will be evaluated six months after patients showing benefit move to the Zephyr Valve.
According to Pulmonx, these findings could help to confirm early positive data from the ongoing CONVERT Trial (NCT04559464) and possibly support an approval application for the AeriSeal System.
Results from the first 40 CONVERT patients showed that treatment with that system successfully turned 78% of patients negative for collateral ventilation. These people subsequently were treated with the Zephyr Valve system.
“Pulmonx remains at the forefront in developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life,” Glen French, president and CEO of Pulmonx, said in a company press release. “We hope the CONVERT II Trial will move us closer to the goal of helping patients with collateral ventilation to also receive benefit from our Zephyr Valves.”
The Zephyr Valve consists of tiny, one-way valves places in areas of lung disease where air is trapped. It works to let the trapped air escape, improving breathing and easing shortness of breath.
“This is very promising news for patients with severe COPD/emphysema because as the diseases progresses, medications alone often do not control symptoms sufficiently. We know Zephyr Valves can provide durable improvements in lung function, breathing, and quality of life, but for patients with incomplete fissures the treatment does not work effectively,” said Michela Bezzi, MD, with ASST Spedali Civili, University Hospital in Brescia, Italy, one of the clinical sites recruiting patients for CONVERT II.
“Having a technology to seal openings in fissures means we can improve the lives of many more patients using minimally invasive procedures,” Bezzi said.
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