Positive Results From Clinical Trial Designed To Evaluate Safety And Efficacy Of Biodesign™ Vaginal Erosion Repair Graft

Main Category: Women's Health / Gynecology
Article Date: 11 Mar 2009 - 5:00 PDT

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An 11-month clinical study led by Manish P. Patel, M.D., generated positive results on Cook Medical's Biodesign™ Vaginal Erosion Repair Graft for the treatment of vaginal mesh exposures, a common complication resulting from the use of synthetic mesh in pelvic floor repair, the procedure used to treat pelvic organ prolapse. The results, which confirmed the safety and efficacy of Biodesign, were presented at the 2009 Society for Urodynamics and Female Urology Winter Meeting in Las Vegas.

The study examined the efficacy of the Biodesign Vaginal Erosion Repair Graft in treating 10 women with large, symptomatic extrusions that resulted from the use of polypropylene or synthetic mesh in a previous pelvic floor reconstruction procedure. To treat the complication, the exposed synthetic mesh was completely removed and the Biodesign graft was implanted to help fully restore and repair the pelvic floor. Research findings showed that all 10 large mesh exposures were successfully repaired with the Biodesign graft with no evidence of recurrence or further complication.

According to the National Institute of Health, an estimated one-third of all U.S. women are affected by pelvic floor disorders including pelvic organ prolapse, a condition that occurs when the pelvic muscles become weakened and stretched, often as a result of childbirth. Although pelvic floor reconstruction is the most common form of treatment, synthetic mesh-based procedures have recently come under scrutiny after the FDA received more than 1,000 reports of rare but serious complications, including vaginal erosion, linked specifically to the use of synthetic mesh. Cook's Biodesign Vaginal Erosion Repair Graft will play an especially important role in treating these synthetic mesh-based complications and more.

"The surgical repair of prolapse remains one of the most difficult challenges in pelvic floor reconstruction due to the large recurrence rate and postoperative complications including foreign body reaction and mesh extrusion," said Patel, who is a physician at Piedmont Urology Associates in North Carolina. "I'm pleased that Biodesign has proven to be an effective and lasting treatment option for patients suffering from painful, large-scale vaginal mesh exposures."

The Biodesign Vaginal Erosion Repair Graft incorporates the best attributes of a biologic graft - resistance to infection and complete remodeling - with the added benefits of moderate price, ease of use and ample shelf life for on-site availability. Upon deployment, the graft reinforces the pelvic floor or vaginal wall and, over time, communicates with the patient's body, signalling surrounding tissue to grow across the scaffold where the pelvic floor needs to be repaired. Unlike synthetic mesh, Biodesign is resistant to infection, encapsulation and erosion into surrounding tissue.

"The complications associated with the use of synthetic mesh in treating pelvic organ prolapse can clearly cause a significant decrease in quality of life for women," said Andy Cron, vice president of Cook Medical's Surgery strategic business unit. "The results of this study come at a very important time, as reports continue to surface around the complications resulting from synthetic mesh treatments. We are excited by the results of Dr. Patel's research and look forward to providing many women with a natural, lasting solution."

About Cook Medical

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.

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