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

    nwoodcock@pulmonx.com

  • 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