In the CONVERT clinical trial, the AeriSeal system shows early success in changing the collateral ventilation status in patients with Advanced COPD/Emphysema, making them eligible for BLVR therapy with Zephyr Valves
Pulmonx, a US-based developer of minimally invasive lung disease treatments, has unveiled positive interim results for its AeriSeal System, from the CONVERT Study.
CONVERT is an open-label, multi-centre, single-arm study, planned to enrol 140 subjects with severe emphysema and collateral ventilation in the target lobe, at up to 20 sites.
The study protocol is designed to evaluate the utility of AeriSeal System in closing the collateral air channels in lung lobe of a patient with severe COPD/emphysema.
In the study, interim data from the first 40 patients showed that the AeriSeal System was successful in 78% of patients, who were subsequently treated with Zephyr Valves.
Pulmonx president and chief executive officer Glen French said: “This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life.
“These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.”
The AeriSeal System uses a synthetic polymer foam to close the collateral air channels, converting the target lung lobe to having little to no collateral ventilation (CV-).
The patients with untreated collateral ventilation (CV+) in lungs are not eligible for Bronchoscopic Lung Volume Reduction (BLVR) therapy with Zephyr Valves.
Zephyr Valve is a minimally invasive treatment option intended for patients with severe COPD/emphysema.
The valves are placed via bronchoscopy to block a diseased portion of the lung, to release the air trapped inside and reduce hyperinflation.
After converted to CV-, patients are eligible be treated with Zephyr Valves, which could improve lung function, quality of life, and exercise capacity for patients.
The patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction (TLVR) with a mean reduction of greater than one litre, said Pulmonx.
University Hospital, Brescia, Italy interventional pulmonology department head Michela Bezzi said: “This is very promising news for patients with advanced COPD.
“We know that treatment with Zephyr Valves can provide long-term improvements in lung function, breathing, and quality of life, but for patients with collateral ventilation, this minimally invasive treatment has not been available as an option.
“Having a technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide a treatment to patients who currently have very few options.”