Cook Women’s Health (Spencer, Indiana), a division of Cook (Bloomington, Indiana), is introducing its Transcervical Pelvic Venogram, designed to diagnose Pelvic Congestion Syndrome, one of the many causes of chronic pelvic pain at the International Pelvic Pain Society (Birmingham, Alabama) annual meeting, held today and Saturday in San Antonio.

The company said chronic pelvic pain affects about 15% of women ages 18-50 and has a “drastic negative impact” on the quality of a woman’s life.

A number of causes can be the source of pelvic pain, including endometriosis, interstitial cystitis or pelvic injury. The challenge for physicians has always been to diagnose the correct source of the pain.

“In the market today, there is no product like that available,” Christina Ann , global leader of Cook’s Women’s Health, told Medical Device Daily. “Right now, it’s always been a guess of where does that pelvic pain come from. The [device] will actually give one target, so they don’t have to look at all targets any longer. [Physicians] will know straightaway if the pain is Pelvic Congestion Syndrome.”

Cook said that pelvic veins are vulnerable to chronic dilation, which can lead to vascular congestion. Because pelvic veins are thin-walled, unsupported and are attached “relatively weakly” to supporting tissue, they may bulge, stretch or dilate.

That bulging or dilating causes pelvic congestion, essentially similar to varicose veins found in the legs. That condition leads to chronic pelvic pain.

“Pelvic congestion can be severe and hinder a woman’s ability to walk, exercise, sleep, conduct chores and, in some patients, may inhibit any type of activity,” the company said.

Cook’s solution to the problem of diagnosis begins with a catheter through which is threaded a tiny needle, Ann said. That catheter is inserted intravaginally, forwarded through the cervix and on toward the very top of the uterus.

At the top of the uterus, the needle is inserted and injects a dye, which reveals the veins of the abdomen. That, in turn, enables physicians to determine if the veins of the pelvis are congested when used in conjunction with a fluoroscope, which would show the veins fluorescently on a small screen in real-time using X-ray.

This, in some cases, will work to determine that a hysterectomy is not needed, if a patient knows the precise source of her pain. Or it might avoid medication treatment for endometriosis, when PCS is actually the cause of the pain.

Cook will be marketing not only to gynecologists — and training them in the procedure — but also to radiology departments, with an educational component to its marketing.

“When a woman is in pain, her first gatekeeper is a gynecologist,” Ann said. “When we have pelvic pain, we don’t tend to go to a radiologist or surgeon. We may be referred to those people, but ... a gynecologist can do this procedure.”

Ann noted that Cook has seven divisions, one of which is devoted to radiology and diagnostics, and the device would be offered by that division, as well.

Cook’s Women’s Health unit was launched in May at the American College of Obstetrics and Gynecology (ACOG; Washington) annual meeting in Washington (Medical Device Daily, May 9, 2006).

The division’s mission is to develop solutions for health problems specific to women, such as infertility, pelvic organ prolapse and incontinence.

Ann said that the company is targeting the development of products to treat health problems throughout a woman’s life-cycle, from age 20 to 60 and older.

In July, for example, the Cook Women’s Health division introduced the Bakri Postpartum Balloon, which is intended to treat women suffering from hemorrhage following childbirth (MDD, July 18, 2006).

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