In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
The study is a prospective observational study to collect safety information about the IBV Valve
System for the treatment of prolonged air leak. Eligible subjects will be enrolled into the study on the day of valve treatment. The subjects will be monitored after treatment until discharge from the hospital (a minimum of 1 night stay after the procedure). After discharge, the subjects will be seen by the investigator for assessment of air leak status as clinically indicated. Valves will be removed after the air leak is resolved. If the air leak is not resolved, the valves will be removed no longer than 6 weeks after device placement and other options can be considered.
Study Population Description
Patients with prolonged air leaks of the lung, or significant air leaks that are likely
to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS).
32 patients will be enrolled at up to 15 clinical sites.
The safety endpoints include the total number, rate, type, timing, duration, severity and relationship to
device or procedure of adverse events. Probable benefit data includes: 1) A positive response in air leak resolution; 2) Number of days after valve placement.
Followup Visits and Length of Followup
The duration of follow-up is a maximum of 6 weeks.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
100% (32/32 as per protocol)
Final Safety Findings
No unanticipated adverse device effects (UADE) have been reported for the Spiration PAS.
SAE: There have
been a total of two reported adverse events in two of the 32 subjects treated. One was serious and one was moderate. Both AEs are summarized below:
Systolic arrest experienced prior to valve placement (day 0): reported as a serious adverse event (SAE), but deemed “Not related” to the device or the procedure. Notes provided on the CRF indicate that the event was due to acidosis from hypercapnia and resolved the same day.
Atelectasis and thick mucus secretions in the left main stem bronchus experienced on day five. One of the four placed valves was removed to treat and meds were given; the event resolved in one day. The investigator deemed this event moderate and “Possibly” related to the device.
Final Effectiveness Findings
Of the 32 subjects who received valves for treatment of air leak, 30 (94%) showed
a positive response to valve placement. Two subjects (6%) showed no improvement in air leak. Of the 30 responders, eleven (11), or 36.7%, were noted as completely resolved. Nineteen (19), or 63.3%, of the subjects were classified as improvement in the air leak. There were no significant differences in the results between
the single use catheter and reloadable catheter groups.
Study Strengths and Weaknesses
Strength: 100% follow-up
Weaknesses: Limited number of female patients (10), small sample size (32), and no
concomitant control group was included.
If a new enrollment Post-Approval Study is required, FDA recommends considering exploring the possibility of using external registry on post-surgical prolonged air leaks data; for example, registries already established created and maintained by a professional organization, academia, and/or government, available inside or outside US, as potential platforms of existing infrastructure to conduct the PAS study.
Recommendations for Labeling Changes
The PAS study design, methods and results must be included in the labeling. Additionally, it
should be indicated the reason why seven (7) valves could not being implanted.