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Results from multiple clinical trials enabled the Hem-Avert® Perianal Stabilizer device to receive the following indications for use:

The Hem-Avert® Perianal Stabilizer provides counter-pressure to the anus during vaginal childbirth. This counter pressure force, applied at 8-10 cm of dilation, is intended to help reduce the likelihood of Cesarean Delivery. Additionally, this counter-pressure force helps prevent the occurrence of external hemorrhoids during vaginal childbirth.

The Hem-Avert® Perianal Stabilizer was granted de novo status on Feb. 1, 2011 and again on December 19, 2016. Copies are available here.

Per classification 21 CFR of the Federal Register the device is described as: A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery. FDA Registration.

Instructions For Use available here.