Three months after introducing a product designed to treat pelvic organ prolapse, Cook Women’s Health (Spencer, Indiana), a division of Cook Medical (Bloomington, Indiana), late last month launched a new device using the same materials to treat recto-vaginal fistulas – abnormal tracts that form between a women’s rectum and vagina.

In August the company introduced the Surgisis Biodesign, a product intended to help the pelvic floor repair itself naturally, offering what Cook called a more permanent solution to pelvic organ prolapse (Medical Device Daily, Aug. 29, 2007).

By using the same natural biodesign material – a pig-derived tissue – Cook calls the Surgisis Biodesign Recto-Vaginal Fistula Plug (RVP) a “major step forward” in the treatment of recto-vaginal fistulas.

While rare in the U.S., the condition is fairly prevalent in developing countries, Jeanny Chung, a product manager at Cook Women’s Health, told Medical Device Daily.

Each year thousands of women around the world suffer from rectal-vaginal fistulas, the company said. According to Cook, fistulas are most commonly the result of prolonged labor, lacerations or episiotomies during delivery. Inflammatory bowel diseases such as Chron’s and ulcerative colitis may also cause fistulas. Also, the company noted, radiation of the pelvis or perineum to treat malignancies can lead to a fistula.

Recto-vaginal fistulas can be quite embarrassing for women who have the condition, Chung said, because she may be expelling gas or feces through the vagina. Other effects may include fecal odor in the vaginal discharge, recurrent bouts of vaginitis and cystitis, pain during intercourse, and fecal incontinence. The condition also can impact the woman’s quality of life, the company said, as fistula victims in some developing countries are shunned by their communities.

“Recto-vaginal fistulas are painful and life-altering – both physically and emotionally – for the women effected,” said Christina Ann , global business unit leader of Cook Women’s Health.

In patients with pelvic organ prolapse, the Surgisis Biodesign is designed to communicate with the patient’s body, signaling surrounding cells to grow across the scaffold, allowing the body to repair itself.

For fistula patients, the Surgisis Biodesign RVP also communicates with the patient’s body, signaling surrounding tissue to grow across the plug and allowing the fistula tract to close, Cook said. This supports the healing process by attracting cells and nutrients to the wounded area, the company noted.

Once the healing process is complete, the device is undetectable and leaves a strong repair, Cook said. That process typically takes about eight to 10 weeks, Chung said.

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, Cook said. They also may require multiple surgeries.

The Surgisis Biodesign RVP is a minimally-invasive alternative to surgery, Chung said. The product combines attributes of synthetic mesh and biologic grafts resulting in “the best of both worlds,” she said.

According to Cook, the Surgisis Biodesign material is not just a new type of standard mesh or graft, but a new category in tissue repair.

Chung said there are four key attributes associated with the materials used: resistance to infection, complete remolding, long-term strength and the ability to signal the body to repair itself.

Cook launched its Women’s Health unit in May of last year (MDD, May 9, 2006), and it grew 30% in its first year (MDD, May 11, 2007). The unit addresses various areas of women’s health issues, including pelvic floor repair, high-risk obstetrics, assisted reproductive technology and gynecological imaging.

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