CONVERT II will assess the safety and effectiveness of the device in reducing collateral ventilation in patients with severe COPD or emphysema
Pulmonx treats first patient in the CONVERT II Pivotal Trial with the AeriSeal System. (Credit: Robina Weermeijer from Unsplash)
Pulmonx, a Nasdaq-listed medical technology company, has announced the treatment of the first patient in the CONVERT II Pivotal Trial with the AeriSeal System.
CONVERT II is a multicentre, global study that will assess both the safety and effectiveness of the device in reducing collateral ventilation in patients with severe chronic obstructive pulmonary disease (COPD) or emphysema.
The findings from the six-month study will be utilised to bolster a pre-market approval (PMA) application for the AeriSeal System. The study aims to enroll up to 200 patients across approximately 30 sites located in the US, Australia, and Europe.
According to Pulmonx, collateral ventilation arises from gaps in the lung fissures or partitions separating lung lobes. The AeriSeal System is engineered to seal these inherent gaps within a targeted lobe intended for bronchoscopic lung volume reduction (BLVR) and to inhibit collateral ventilation.
Following treatment with the AeriSeal System, patients undergo treatment with the commercially available Zephyr Valves.
Pulmonx obtained a staged investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.
Pulmonx president and CEO Glen French said: “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.
“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 primary objective of the CONVERT II Pivotal Trial is to ascertain the safety and efficacy of employing the AeriSeal System to address and manage the fissural defects responsible for collateral ventilation between lung lobes. This enables certain severe COPD/emphysema patients to benefit from BLVR with Zephyr Valves.
Individuals diagnosed with severe COPD/emphysema and confirmed collateral ventilation using Pulmonx’s proprietary Chartis Pulmonary Assessment System (Chartis) are eligible for treatment with the AeriSeal System.