Plexus Biomedical has been granted a new classification and approval from the Food and Drug Administration (FDA) to market Hem-Avert Perianal Stabilizer device to prevent external hemorrhoids during vaginal childbirth.
The patented Hem-Avert Perianal Stabilizer supports the perianal region of the patient during labor and delivery.
The device is easily applied, completely external and will soon be available to physicians and hospitals nationwide.
Plexus Biomedical CEO David Blurton said since there were not any competitive products or predicate devices that addressed delivery-induced hemorrhoids, the company conducted a prospective, randomized, multicenter clinical study to provide the clinical data necessary for the FDA to create a new classification for the device through its de novo 510(k) process.
Findings from the clinical study showed that none of the women randomly chosen to use the Hem-Avert device during labor and delivery developed hemorrhoids.