CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema
The reported data suggest that patients with collateral ventilation may be able to undergo successful treatment with Zephyr Endobronchial Valves following closure of collateral air channels with the AeriSeal System
The AeriSeal System is used to close collateral air channels in a target lung lobe of a patient with severe COPD/emphysema, making the patient eligible to then undergo Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves. Patients whose lungs have untreated collateral ventilation (CV+) are currently ineligible for treatment with Zephyr Valves and have limited options once medical management alone does not control symptoms. Once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves, which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.1
The CONVERT study uses the AeriSeal System to close collateral air flow. Once the treated lobe tests negative for collateral ventilation (CV-), Zephyr Valves are implanted to address hyperinflation of that target lobe to ease emphysema symptoms without major surgery. Successfully converted patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction (TLVR) with a mean reduction of greater than one (1) liter. The CONVERT trial is ongoing and full clinical outcomes of BLVR with Zephyr Valves were not reported at this time. However, results recently published from a single-center feasibility study at
- Lung function (FEV1 increase of 19.7%, Residual Volume decrease of 16.2%)
- Quality of life (SGRQ score decrease of 15.1 points)
- Exercise capacity (Six-Minute Walk Distance increase of 77.2 meters)
There were no serious adverse reactions experienced by patients in the Australian feasibility study; 20% of patients in the CONVERT Study experienced an inflammatory response following AeriSeal treatment - all were transient, medically managed, and resolved. The available data suggest that patients with collateral ventilation can undergo successful BLVR with Zephyr Valves following closure of the fissure gap with the AeriSeal System.
“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,” explains Dr.
“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,” states
About the CONVERT Study
CONVERT is a prospective, open-label, multi-center, single-arm study being conducted at up to 20 investigational sites. The study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System, which uses a synthetic polymer foam to occlude (close) collateral air channels in a target lung lobe and convert the target lung lobe to having little to no collateral ventilation (CV-). Patients will then undergo Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves. Zephyr Valves are not effective if collateral ventilation (CV+) is present but once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.1 See https://clinicaltrials.gov/ct2/show/NCT04559464 for more details on the CONVERT Study.
The AeriSeal System is not approved by the FDA or approved for commercial sale in
About Zephyr Valves
The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema. Zephyr Valves are placed via bronchoscopy to 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. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life.1 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. More than 25,000 patients have been treated with the Zephyr Valve worldwide.
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1Criner G et al. Am J Respir Crit Care Med. 2018; 198 (9): 1151–1164.
2Ing AJ et al. Respirology. 2022. https://doi.org/10.1111/resp.14338.