Cook Medical Announces Breakthrough Device for Diagnosis of Abnormal Uterine Bleeding.

Goldstein SonoBiopsy[TM] Catheter Provides Physicians Two Diagnostic Options in One Device

SPENCER, Ind. -- Cook Medical, the world's largest privately held medical device company, today announced the availability of the first of its kind Goldstein SonoBiopsy[TM] Catheter for use in diagnosing the cause of abnormal uterine bleeding. The Goldstein SonoBiopsy Catheter is unique in that it combines Saline Infusion Sonohysterography (SIS) and biopsy functionality in a single device. The new device provides physicians with the increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to biopsy endometrial tissue during the same procedure. In addition, the Goldstein SonoBiopsy[TM] Catheter eliminates the need to introduce additional instruments into the patient's body and reduces the incidence for multiple procedures.

Abnormal uterine bleeding affects 10 million women in the United States and accounts for approximately one-third of all visits to the gynecologist.(i) In the most severe cases, abnormal uterine bleeding can be a sign of endometrial cancer, leukemia or a coagulation disorder. It can also result in anemia if not treated quickly and effectively. Even less severe cases may dramatically affect a woman's daily activities and can have a negative affect on overall quality of life.

The Goldstein SonoBiopsy Catheter allows physicians to fill the uterus with saline solution, enabling better echo-resonance of the uterine cavity during an ultrasound. The catheter's unique acorn-shaped stopper keeps the fluid inside the uterus and prevents it from draining, allowing superior uterine imaging during the procedure. If the physician determines that an endometrial biopsy is required, the Goldstein SonoBiopsy Catheter also allows the physician to simply apply suction to the catheter to aspirate an appropriate tissue sample for evaluation. The diagnostic procedure is completed during one patient visit.

Dr. Ted Cox collected and presented his recent experiences with the Goldstein Sonobiopsy Catheter at the 2007Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Diego. His experiences demonstrated that the Goldstein SonoBiopsy Catheter reduced procedure time by 30 percent when compared to other devices. In addition, patient discomfort was significantly reduced as the need to re-insert the speculum and place in a different catheter for collection of material for the endometrial biopsy was eliminated.

According to Dr. Cox, "With the Goldstein SonoBiopsy Catheter, Cook Medical has taken the next steps in the continued improvement of the work-up and triage of abnormal uterine bleeding. The Goldstein SonoBiopsy Catheter has significantly reduced procedure times and patient discomfort while still producing an excellent sonohysterogram and providing an accurate endometrial biopsy all in the same catheter."

"Given the nature of abnormal uterine bleeding, diagnosis often requires many invasive tests that can be uncomfortable and extremely time consuming for patients," said Christina Anne, Global Leader of Cook Women's Health. "With the Goldstein SonoBiopsy Catheter, we've reduced patient discomfort by combining two of the most common tests into one device, thus reducing the need for multiple procedures.

About Cook Women's Health

Cook Women's Health has brought a new level of patient-centered innovation to the global market recognizing that women have special health and medical needs. Cook Women's Health will continue to uniquely address prevalent areas of women's health including pelvic floor repair, high-risk obstetrics, assisted reproductive technology and gynecological imaging.

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.

(i) Meniru GI, Hopkins MP. Abnormal Uterine Bleeding. In: Curtis A, Overholt S, Hopkins MP, eds, Glas's Office Gynecology. Philadelphia, PA; Lippincott Williams & Wilkens; 2006: 177.