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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Synchromed II


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General
Study Status Completed
Application Number P860004 S056/ PAS001
Date Current Protocol Accepted 09/12/2003
Study Name Synchromed II
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a 12-month, multi-center, single arm prospective cohort study. All subjects in the study receive the device.
Study Population Description Study population: Patients at least 18 years old receiving the infusion system for the treatment of chronic, intractable pain or severe spasticity 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, preservative-free morphine sulfate for chronic, intractable pain of malignant and/or benign origin; 2) Chronic intrathecal infusion of preservative-free 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 post-implant.
Follow-up Visits and Length of Follow-up Data were to be collected at the following visits: baseline evaluation, system implant, 1, 6, and 12 months post-implant, interim refill visits, and visits for adverse events.
Interim or Final Data Summary
Actual Number of Patients Enrolled 82 patients enrolled, 80 implanted
Actual Number of Sites Enrolled 9
Patient Follow-up Rate 85%
Final Safety Findings All the subjects included in the primary analysis had accuracy ratios within the prespecified interval. Thirty-eight subjects experienced 58 device-related 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 & Weaknesses Strengths: The study assessed known potential serious adverse event through capturing dispensing. Weaknesses: The study did not capture over- and under-infusions resulting in toxicity/overdose or decreased therapeutic responses as potentially device-related events. The study did not account for differences in pump function with approved, non-approved, or compounded drugs. The pre-specified interval was wide and included both very high and very low values.
Recommendations for Labeling Changes There were no recomendations were made for labeling changes.


Synchromed II Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final report 03/12/2007 05/15/2007 Overdue/Received
30 month report 11/14/2007 11/14/2007 On Time
36-Month Interim Report 05/01/2008 05/01/2008 On Time
Final Report 05/31/2009 05/04/2009 On Time


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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