A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System

Exclusion Criteria

• •1. Invasive mechanical ventilation \>90 days.
• •2. Currently on extracorporeal membrane oxygenation (ECMO).
• •3. Weaning failure due to hypervolemia.
• •4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
• •5. Clinically overt congestive heart failure that is preventing weaning.
• •6. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction.
• •7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
• •8. Pre-existing severe chronic pulmonary fibrosis.
• •9. Known pleural effusions occupying greater than one third of the pleural space on either side.
• •10. BMI \>70 kg/m2.
• •11. Known or suspected phrenic nerve paralysis.
• •12. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators.
• •13. Current hemodynamic instability
• •14. Uncontrolled sepsis or septic shock.
• •15. Current or untreated bacteremia.
• •16. Expecting withdrawal of life support and/or shift to palliation as the goal of care.
• •17. Known or suspected to be pregnant or lactating.
• •18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.