A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
• Signed Informed Consent
• Diagnosis of COPD/emphysema
• At least 22-years of age
• 18 ≤ BMI ≤ 32
• 6-minute walk Distance of between 100 - and 400 meters
• Stable disease with less than 10-mg prednisone (or equivalent) daily
• Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
• FEV1 between 15% and 45% of predicted value at baseline exam
• FEV1/FVC \<70%
⁃ Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
⁃ Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
⁃ RV \> 175% of predicted value.
⁃ mMRC score ≥ 2