Healthcare Industry News:  Cook Medical  


 News Release - November 27, 2007

Cook Medical Delivers Innovative Treatment for Recto-Vaginal Fistulas

Surgisis(R) Biodesign(TM) Recto-Vaginal Fistula Plug offers Patients and Physicians a Safe Solution for Distressing Condition Affecting the Health and Quality of Life for Thousands of Women

SPENCER, Ind.--(HSMN NewsFeed)--Cook Medical, one of the world’s largest private medical device companies, announced today a major step forward in the treatment of recto-vaginal fistulas, abnormal tracts that form between a women’s rectum and vagina. The Surgisis® Biodesign™ Recto-Vaginal Fistula Plug communicates with the patient’s body, signaling surrounding tissue to grow across the plug and allowing the fistula tract to close. This action supports the healing process by attracting cells and nutrients to the wounded area. Once the healing process is complete, the Surgisis Biodesign Recto-Vaginal Fistula Plug is undetectable and leaves a strong repair.

Each year around the world, thousands of women suffer from recto-vaginal fistulas caused by a number of conditions. Fistulas are most commonly the result of prolonged labor, lacerations or episiotomies during delivery. Fistulas may also be caused by inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. Additionally, radiation of the pelvis or perineum to treat malignancies can also lead to a fistula.

For a woman suffering from a fistula, the effects can be embarrassing and painful. In addition, they can profoundly impact the quality of daily life. Side effects may range from the passage of gas and/or feces through the vagina, to fecal odor in the vaginal discharge, recurrent bouts of vaginitis and cystitis, pain during intercourse, and/or fecal incontinence. Any or all of these symptoms can lead to significant emotional distress for the patient. In developing countries, fistula victims are often ostracized and even shunned by their communities.

Current treatment for recto-vaginal fistulas includes surgery with the addition of fibrin glue to plug the tract and repair with a graft made of synthetic materials. However, the synthetic materials can increase the risk of infection, erosion into adjacent tissue and the growth of scar tissue. They also may require multiple surgeries that can take a toll on a patient’s physical, mental and emotional health. The Surgisis® Biodesign™ Recto-Vaginal Fistula Plug is resistant to infection, encapsulation and erosion into surrounding tissue areas. Once the healing process is complete, the plug is undetectable and provides a repair without the use of a permanent material.

“Recto-vaginal fistulas are painful and life-altering – both physically and emotionally - for the women effected,” said Christina Anné, Global Leader of Cook Medical’s Women’s Health Strategic Business Unit, one of two Cook Medical divisions responsible for global marketing of the new fistula plugs. “We’re pleased to provide these women and their physicians with a safe, comfortable and natural treatment option to repair this condition. We’ve seen great success with a similar product for anal fistulas and believe the Recto-Vaginal Fistula Plug delivers the same positive impact on patient quality of life.”

Cook Medical has brought a new level of patient-centered innovation to market recognizing that women have special health and medical needs. Cook Medical will continue to uniquely address prevalent issues in women’s health globally including infertility, high-risk obstetrics, chronic pelvic pain, pelvic organ prolapse, and stress urinary incontinence.

About Cook Medical:

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit

Source: Cook

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