Cook Medical Delivers Innovative Treatment for Recto-Vaginal Fistulas.Surgisis[R] Biodesign[TM] Recto-Vaginal Fistula fistula (fĭs`ch  lə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin. Plug offers
Patients and Physicians a Safe Solution for Distressing Condition
Affecting the Health and Quality of Life for Thousands of Women
SPENCER, Ind. -- 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[R] Biodesign[TM] 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 prolonged labor Obstetrics Labor of > 24 hrs duration, which may be due to a prolonged latent phase–> 20 hrs in a primigravida or > 14 hrs in a multipara, or due to a 'protraction disorder' in which there is protracted cervical dilatation in the , lacerations or episiotomies during delivery. Fistulas may also be caused by inflammatory bowel diseases such as Crohn's disease Crohn's disease: see colitis. and ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . Additionally, radiation of the pelvis or perineum perineum /peri·ne·um/ (-ne´um) 1. the pelvic floor and associated structures occupying the pelvic outlet, bounded anteriorly by the pubic symphysis, laterally by the ischial tuberosities, and posteriorly by the coccyx. 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 Side effects Effects of a proposed project on other parts of the firm. may range from the passage of gas and/or feces through the vagina, to fecal odor in the vaginal discharge, recurrent bouts of vaginitis vaginitis Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for and cystitis cystitis (sĭstī`tĭs), common acute or chronic inflammation of the urinary bladder. The disease occurs primarily in young women and frequently results from bacterial invasion of the urethra from the adjacent rectum, most commonly with , 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[R] Biodesign[TM] 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 Anne, 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 Women and Pelvic pain Most women (and some men), at some time in their lives, experience pelvic pain. When the condition persists for longer than 3 months, it is called chronic pelvic pain (CPP). , pelvic organ prolapse prolapse Protrusion of an internal organ out of its normal place, usually of the rectum or uterus outside the body when supporting muscles weaken. The membrane lining the rectum can push out through the anus, most often in old people with constipation who strain during , and stress urinary incontinence stress urinary incontinence n. See stress 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 www.cookmedical.com. |
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