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A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
Full description
A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:
A minimum of 4 sites in the United States will perform chart review and enter 116 study records in the database for data collection. The 116 subject records will be comprised of 76 for the inguinal/femoral indication, and 40 for the ventral indication.
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Inclusion criteria
Exclusion criteria
Institutional Review Board (IRB) consent requirement cannot be met:
Subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window
Subject was pregnant at the time of procedure
Subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant
Subject was treated with any other implantable mechanical fixation device, other than sutures
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Data sourced from clinicaltrials.gov
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