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FDA Approval for device made of Nonwoven to Prevent Hemorrhoids during Vaginal Birth.

01 Mar '11

2 min read

Plexus Biomedical Inc. has been granted a new classification and approval from the Food and Drug Administration to market the first device clinically shown to help prevent external hemorrhoids during vaginal childbirth. Hemorrhoids associated with vaginal delivery are a frequent complication of childbirth and affect between 750,000 and 1,000,000 pregnant women in the U.S. every year.

The patented Hem-Avert® Perianal Stabilizer supports the perianal region of the patient during labor and delivery. The unique device is easily applied, completely external and will soon be available to physicians and hospitals nationwide.

CEO David Blurton stated, "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. By contrast, 25% of the women in the control group who delivered without the Hem-Avert® device developed hemorrhoids as a direct result of vaginal delivery, a finding consistent with the reported incidence of hemorrhoids documented in medical literature.

The high incidence of delivery-induced hemorrhoids among all vaginal births yields a potential U.S. market in excess of $650M. When combined with vaginal births from Canada and Europe, the potential market for the Hem-Avert® device doubles to $1.3B. The company believes better patient outcomes, cost savings, and patient demand will all contribute to the product's success.

Plexus Biomedical is dedicated to revolutionizing obstetrics by eliminating or reducing common problems and morbidities associated with childbirth. The company already has two issued United States Patents covering the Hem-Avert® Perianal Stabilizer with additional patent applications pending in the United States and internationally.

Image Source: MedGadget

Plexus Biomedical Inc.