Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Emphysema.

Current treatment of emphysema (COPD gold III-IV) generally is limited to
palliative measures that include supplemental oxygen, bronchodilators,
anti-inflammatory drugs and pulmonary rehabilitation or to lung
transplantation. A small subset of patients with a heterogeneous pattern of
emphysema might be benefited by lung volume reduction surgery, but this
procedure is highly invasive and often results in high morbidity and mortality.
A minimally invasive treatment with the potential to improve pulmonary function
and reduce dyspnea in patients with homogeneous emphysema would provide
meaningful clinical benefit.

To evaluate the safety and effecacy of the Lung Volume Reduction Coil to
improve QOL pulmonary function for emphysema subjects with severe
hyperinflation.

Non randomized, multicenter, uncontrolled trial

Nitinol Lung Volume Ruduction Coils will be placed in both lungs during two
bronchoscopic procedures, with an interval of 3 months because of safety
follow-up, aiming to induce a volume reduction and therefore aiming to improve
the clinical status of emphysema patients with severe hyperinflation by
improving pulmonary mechanics.

The patients that will be screened for potential participation will recieve
pulmonary function testing, thoracic HRCT scanning (both are often already
available) and an outpatient visit. The patients that will be included will
have to come to our outpatient clinic, perform pulmonary function testing, a 6
min walking test, thoracic x-ray and testing of blood samples and arterial
bloodgas. For the actual treatment with bronchoscopy under general anesthesia
the patients will stay two times two days in our hospital. For the follow-up, 2
HRCT scans, 6 pulmonary function tests, six 6 min walking tests and 6
outpatient clinic visits will be needed

The included patients will have to put large effort in the study, but is in
balance with the expected outcome and very limited compared 'alternative'
treatments like highly invasive surgery: Lung volume reduction surgery or Lung
transplantation. All included patients have a severe limitation of their
activities of daily living. With the development and validation of the use of
the airway bypass procedure does it seem possible to give -at least
temporarily- relieve of shortness of breath and improvement in expercise
performance. Furthermore can this technique be used as a 'bridge' to
lungtransplantation in future, or will be the only possible therapeutic tool
available by then. The risks are not bigger than the risks any individual has
for the investigations described. The actual treatment with the LVR-Coils can
cause: airway bleeding, airway infections and fever, pneumothorax, cough (that
might result in an additional bronchoscopy to remove the coils), or death as a
result of one of these complications.