A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications: 1. inguinal/femoral hernia 2. ventral hernia 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.
Study Type
OBSERVATIONAL
Enrollment
116
ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks
Hudson Valley Surgical Group
Sleepy Hollow, New York, United States
To confirm the safety for this device during inguinal/ femoral and ventral hernia repair procedures by assessing the proportion of subjects with SADE's/AEs
Safety will be assessed as the proportion of subjects with SADE's/AEs
Time frame: 30 days (+3 days) post procedure
The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures
The rate of device-related malfunctions affecting performance of the device will be captured
Time frame: 30 days (+3 days) post procedure
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