Questions for the Panel to consider: Devices for treatment of Emphysema
- What is the appropriate control group for a
clinical evaluation of these devices?
For example, for which patients would LVRS be an appropriate
control group, and for which patients would medical management be an
appropriate control group?
- Clinical trials for these devices will be
required to demonstrate safety.
Please comment on what you believe to be the most important safety
parameters to be evaluated in clinical trials of these devices (e.g.,
rehospitalization, COPD exacerbation, air leak, pneumonia, infection,
hemoptysis, respiratory failure, death).
- Clinical trials for these devices will also be
required to demonstrate effectiveness.
Please discuss the merits of each of the parameters below as well
as any other parameters that you believe to be important to demonstrating
device effectiveness. When
possible, please discuss the degree of improvement or decline that would
be clinically significant for these or other parameters (e.g., an increase
in how many feet in the 6MWT is a significant improvement).
- Pulmonary function (FEV1)
- 6 minute walk test
- Maximum exercise capacity
- Quality of Life (SF-36)
- Dyspnea questionnaires
- Length of hospital stay
- The duration of follow-up should allow FDA to
adequately assess the safety and effectiveness of these permanently
implanted devices in a chronically ill population. Please comment on what you believe to
be the appropriate duration of follow-up for a pivotal clinical study for