First procedure performed in U.S. trial for SprayGel Adhesion Barrier Adhesions August 1, 2002 2002 AUG 1 - (NewsRx.com & NewsRx.net) -- Confluent Surgical, Inc., announced the commencement of its pivotal U.S. trial for the SprayGel Adhesion Barrier in Prevention of Pelvic Adhesions In Laparoscopic Surgery, the PREVAIL Study. Confluent Surgical believes that the SprayGel Adhesion Barrier will prevent and reduce adhesions that are associated with severe postoperative pain and other side effects, which affect millions of women annually.
The first procedure in the PREVAIL Study was performed by Michael L. Twede, MD, FACOG, and Dale A. Sundwall, MD, FACOG, Medical Directors at the Salt Lake City Women's Center. Twede and Sundwall are considered experts in the treatment of endometriosis and adhesions and are respected as highly skilled surgeons.
Twede states, "Based on the early published results, SprayGel appears to represent a breakthrough in adhesion prevention. It is unique in its ability to be applied laparoscopically and remain in place as a barrier for five to seven days, the period when adhesions normally form. If the results from the initial pilot study are replicated in this pivotal study, this product would prevent or significantly reduce patient trauma and costs associated with additional surgery for adhesions."
Adhesions are fibrous bands of tissue between adjacent organs of the body. They typically occur as a result of inflammation incident to surgery and can cause severe pelvic pain and infertility. Adhesions start to form within three hours of surgery and will cease forming when the surgical sites heal, usually within 7 days following surgery. The SprayGel Adhesion Barrier is designed to protect the tissues during this critical healing period. It is estimated that adhesions affect over two million women and men in the U.S. and that the potential U.S. market for abdominopelvic adhesion management is $400-$500 million.
"Based on its early performance in prior pilot trials as well as our early commercial success in Europe, we believe that SprayGel will become the product of choice for gynecologic surgeons to prevent postoperative adhesions," stated Amar S. Sawhney, president and CEO of Confluent Surgical, Inc. This article was prepared by Women's Health Weekly editors from staff and other reports.
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