Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV
Research type
Research Study
Full title
Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures
IRAS ID
262755
Contact name
Nick Woodcock
Contact email
Sponsor organisation
Pulmonx Corporation
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The Pulmonx Zephyr® Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks. The Zephyr Valves come in 4 different sized to accommodate variations in patient anatomy. Sizes 4.0 EBV, 4.0-LP EBV and 5.5 EBV have been available on the European market for many years. The Zephyr Valve size 5.5-LP EBV (catalog no. EBV-TS-5.5-LP) has recently been added to the Zephyr EBV product family as a product line extension. Thus, Pulmonx implemented this Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1632
Date of REC Opinion
2 Dec 2019
REC opinion
Further Information Favourable Opinion