Pulmonx (Nasdaq:LUNG) announced today that it treated the first patient in a pivotal trial evaluating its AeriSeal system.
The CONVERT II evaluates AeriSeal in limiting collateral ventilation in severe chronic obstructive pulmonary disease (COPD)/emphysema patients. Pulmonx received a staged FDA investigational device exemption (IDE) to conduct this trial late last year.
Collateral ventilation occurs when openings appear in the lung fissures or walls between the lung lobes. Pulmonx designed AeriSeal to occlude these naturally occurring openings in a lobe targeted for bronchoscopic lung volume reduction (BLVR) and block collateral ventilation. AeriSeal foam blocks gaps in lung fissures to allow patients to benefit from eventual valve treatment.
If successful, AeriSeal treatment leads to treatment with the commercially available Pulmonx Zephyr valves. Placed via bronchoscopy, the minimally invasive valves block off a diseased portion of the lung. They aim to prevent air from getting trapped and reduce hyperinflation. This allows the healthier lung tissue to expand and take in more air. Zephyr was named one of the most innovative medical devices of 2021.
With CONVERT II, Pulmonx plans to evaluate procedural success (lung volume reduction) and other parameters including lung function, quality of life and exercise capacity at six months post-valve treatment. The company then plans to use the six-month results to support an FDA premarket (PMA) approval. It plans to enroll up to 200 patients across 30 sites in the U.S., Australia and Europe.
“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,” said Glen French, president and CEO of Pulmonx. “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.”