First Clinical Trial Patient Treated With Pulmonx’s AeriSeal System

Pulmonx Corporation has treated the first patient in its CONVERT II Pivotal Trial, a multicenter, international study evaluating the safety and effectiveness of the AeriSeal System in limiting collateral ventilation in severe COPD/emphysema patients.

Collateral ventilation is caused by openings in the lung fissures, or walls between the lung lobes. The AeriSeal System is designed to occlude these naturally occurring openings in a lobe targeted for bronchoscopic lung volume reduction (BLVR) and block collateral ventilation. Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr Valves. Pulmonx received a staged IDE approval by the U.S. Food and Drug Administration (FDA) to commence the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.

“Pulmonx is developing and testing new medical technologies to help patients with severe lung disease breathe easier and have a better quality of life,” Pulmonx President/CEO Glen French said. “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 CONVERT II Pivotal Trial aims to establish the safety and effectiveness of using the AeriSeal System to target and treat the fissural defects that allow collateral ventilation between lung lobes, which preclude some severe COPD/emphysema patients from benefiting from BLVR with Zephyr Valves. Severe COPD/emphysema patients with collateral ventilation confirmed with Pulmonx’s proprietary Chartis Pulmonary Assessment System (Chartis) undergo the AeriSeal System treatment. For those patients who experience conversion (as assessed with the Chartis System 45 days later), Zephyr Valves are implanted per current standard of care for lung volume reduction. Procedural success (lung volume reduction) and other clinical parameters including lung function, quality of life and exercise capacity, will be evaluated at six months post-valve treatment. The six-month results will be used to support a Pre-Market Approval (PMA) application to the FDA. Up to 200 patients will be enrolled at up to 30 sites in the United States, Australia, and Europe. The study will complement the positive experience the company has gained with the CONVERT Trial.¹
 
Endobronchial Valves are small, one-way valves used to reduce lung hyperinflation, the primary cause of breathlessness in patients with severe COPD/emphysema. If collateral ventilation is present, the treated lobe will not deflate, and the valves are not effective. AeriSeal Foam is designed to block gaps in lung fissures so that patients may then benefit from treatment with endobronchial valves like the Zephyr Valve, which have been clinically proven to improve breathing, lung function, and quality of life for patients with advanced disease.²
 
“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,” explained Dr. Michela Bezzi, director of Interventional Pulmonology – ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology to seal openings in fissures means we can improve the lives of many more patients using minimally invasive procedures.”
 
The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema, a chronic, progressive, and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lung’s natural elasticity and the collapse of airways cause air to become trapped in the lung. This makes breathing inefficient, and patients are always short of breath, making the most nominal physical activities difficult. Placed via bronchoscopy, the valves block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves, with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) giving valves an ‘Evidence A’ rating.
 
Pulmonx Corporation develops minimally invasive treatments for chronic obstructive pulmonary disease (COPD). Pulmonx’s Zephyr Endobronchial Valve, Chartis Pulmonary Assessment System, and StratX Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who despite medical management are still profoundly symptomatic. Pulmonx received FDA pre-market approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, is included in global treatment guidelines and is widely considered a standard of care treatment option for improving breathing, activity, and quality of life in patients with severe emphysema. 

References
¹ Eur Respir J 2022; 60: Suppl. 66, 1231.
² Criner et al. Am J Respir Crit Care Med. 2018; 198 (9): 1151-1164.