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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-IBV Valve


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General
Application Number H060002 / PAS001
Current Plan Approved 12/16/2014
Study Name OSB Lead-IBV Valve
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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).
Sample Size 32 patients will be enrolled at up to 15 clinical sites.
Data Collection 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.
Follow-up Visits and Length of Follow-up The duration of follow-up is a maximum of 6 weeks.
Final Study Results
Interim Safety Information The study is pending. No patients have been enrolled.
Number of Patients 39
Number of Sites 11
Follow-up Rate 100% (32/32 as per protocol)
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.

Effect 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.

Strengths & 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.

Label 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.


OSB Lead-IBV Valve Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/01/2009 04/23/2009 On Time
1 year report 11/01/2009 10/21/2009 On Time
18 month report 04/25/2010 04/23/2010 On Time
2 year report 11/01/2010 10/25/2010 On Time
30 month report 04/25/2011 04/25/2011 On Time
36 month report 10/26/2011 10/26/2011 On Time
4 year report 10/23/2012 10/26/2012 Overdue/Received
five year report 10/23/2013 10/28/2013 Overdue/Received
6 year report 11/24/2014 12/02/2014 Overdue/Received
Final Report 02/29/2016 03/01/2016 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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