11/14/2018

Post-Approval Studies (PAS)

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FDA Home3 Medical Devices4 Databases5

Post­Approval Studies (PAS)
The FDA has the authority to require sponsors to perform a post­approval study (or studies) at the time of approval of a premarket
approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post­approval 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) of approved medical devices. This database allows you to search
Post­Approval Study information by applicant or device information.
Learn more...6
 
 

         

   

   

   

Synchromed II
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General
Study Status
Completed
Application
P860004 S056/ PAS001
Number
Date Current
09/12/2003
Protocol Accepted
Study Name
Synchromed II
General Study Protocol Parameters
Study Design
Prospective Cohort Study
Data Source
Sponsor Registry
Comparison
Historical Control
Group
Analysis Type
Analytical
Study Population Transit. Adolescent B (as adults) : 18­21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design
The post­approval study is a 12­month, multi­center, single arm prospective cohort study. All subjects in the study receive the device.
Description
Study Population Study population: Patients at least 18 years old receiving the infusion system for the treatment of chronic, intractable pain or severe spasticity
Description
of spinal or cerebral origin and those receiving an initial pump or replacement pump. Indication for use: The SynchroMed II infusion system is
an implantable, programmable drug delivery system used to treat pain, spasticity, and cancer. It is indicated for: 1) Chronic intraspinal
(intrathecal or epidural) infusion of sterile, preservative­free morphine sulfate for chronic, intractable pain of malignant and/or benign origin; 2)
Chronic intrathecal infusion of preservative­free ziconotide sterile solution for the management of severe chronic pain; 3) Chronic intrathecal
infusion of Lioresa Intrathecal (baclofen injection) for severe spasticity of spinal or cerebral origin; and 4) Chronic intravascular infusion of
methotrexate and floxuridine for the treatment of cancer (not included in this study).
Sample Size
100 subjects, 13 sites
Data Collection
Primary endpoint: comparison of observed refill measurements to calculated volume dispensed for patients with at least 2 refills during the first
six months. Secondary endpoint: descriptive evaluation of all adverse events and technical observations through 12 months post­implant.
Follow­up Visits Data were to be collected at the following visits: baseline evaluation, system implant, 1, 6, and 12 months post­implant, interim refill visits, and
and Length of
visits for adverse events.
Follow­up
Interim or Final Data Summary
Interim Safety
Study completed, see final results.
Information
Actual Number of 82 patients enrolled, 80 implanted
Patients Enrolled
Actual Number of 9
Sites Enrolled
Patient Follow­up 85%
Rate
Final Safety
All the subjects included in the primary analysis had accuracy ratios within the prespecified interval. Thirty­eight subjects experienced 58
Findings
device­related events, the most frequent were: implant site effusion (n=16 events), lumbar puncture headache (n=8), catheter dislodgement
(n=5), and implant site inflammation (n=4). Three events were treated with device explant. The probability of pump survival at 12 months was
95.8%.
Study Strengths & Strengths: The study assessed known potential serious adverse event through capturing dispensing. Weaknesses: The study did not capture
Weaknesses
over­ and under­infusions resulting in toxicity/overdose or decreased therapeutic responses as potentially device­related events. The study did
not account for differences in pump function with approved, non­approved, or compounded drugs. The pre­specified interval was wide and
included both very high and very low values. Thus the data may not be clinically meaningful.

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Recommendations There were no recomendations were made for labeling changes.
for Labeling
Changes

Synchromed II Schedule
Report
 
Date Due
Final report
03/12/2007
30 month report
11/14/2007
36­Month Interim Report 05/01/2008
Final Report
05/31/2009
Report Schedule

FDA Receipt
Applicant's
  Reporting Status
Date
05/15/2007 Overdue/Received
11/14/2007
On Time
05/01/2008
On Time
05/04/2009
On Time

Contact Us
Julie Unger
 
Project Manager, Post­Approval Studies Program 
 
Food and Drug Administration 
10903 New Hampshire Ave   
 
WO66­4206v Silver Spring, MD 
 
20993­0002 
 
 
Phone: (301) 796­6134 
Fax: (301) 847­8140   
 
julie.unger@fda.hhs.gov 
 
 

Related Links
Guidance Document: "Procedures for Handling Post­Approval Studies Imposed by PMA Order" ­ June 15, 20097
PAS Database Background8
PAS FAQs9
 

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5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
6. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostApprovaStudies/default.htm
7. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070974.htm
8. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostApprovaStudies/default.htm
9. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostApprovaStudies/ucm135263.htm
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36. http://www.fda.gov
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45. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
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