CSI entered the colposcopy market with its 1990 acquisition of Frigitronics and later introduced the first overhead colposcopy unit specifically designed for LEEP.

In 1998, CSI introduced, the Cerveillance Scope, which uses digital technology to visualize and document cervical lesions. This is the first device to combine digital imaging technology and proprietary software in a fully integrated compact instrument. CSI became a world leader in colposcopy with its 2000 acquisition of Leisegang Medical, a leading colposcopy manufacturer.

In 1991, CSI introduced the LEEP procedure to the United States market and followed with a complete line of products to surround it. These include the LEEP System 1000 electrosurgical generator, the CooperSurgical Smoke Evacuation System 6080, and the non-conductive, autoclavable instrumentation and ancillary disposable products used in each case. It also includes the Prima Series speculum that resists staining and surface degradation, and disposable products such as sterile single use LEEP electrodes and LEEP RediKit.

Menopause: Menopause is the permanent cessation of menstruation after loss of ovarian function. As the female population has aged, visits related to menopause have grown to over 10 million per year>⁸. The United States Census Bureau projects a 30 percent increase in women in this age group over the next ten years.

Office Based Gynecology Procedures
Reason for Visit	Annual Office Visits, 1999 (000's)		Rank in Annual Visits to Ob/Gyns	Product Categories Used
Gynecological examinations	13,658		Third	• Vaginal specula • Pap smear
Menopause	10,247		Fourth	• Endometrial sampling
Menstrual disorders	5,230		Fifth	• Endometrial sampling • Hysteroscopy
Abnormal Pap smear	4,840		Sixth	• LEEP products • Colposcopes • Pap smear
Vaginitis	4,398		Seventh	• Vaginitis testing
Female genital symptoms	1,570		Tenth	• Cryosurgery • Electrosurgery

Hormone replacement therapy (HRT) is recommended for the primary symptoms of menopause — hot flashes and vaginal atrophy - and to reduce the long-term effects of estrogen deficiency: cardiovascular disease, weakening of the pelvic support structures and osteoporosis. Before starting HRT, physicians often sample cells from the endometrium, particularly when bleeding is irregular or heavy. With some therapeutic regimens, physicians test annually to monitor the thickening of the uterine lining, which occurs in up to 30 percent of women receiving estrogens alone as their HRT⁸ [⁸Menopause. In: Visscher CH, ed. Précis V, An Update in Obstetrics and Gynecology, American College of Obstetrics and Gynecology, 1994; 404. ]

Endometrial cell sampling helps evaluate abnormal uterine bleeding in women at risk for endometrial polyps or abnormal cellular growth. Clinicians regard CSI's Pipelle, a disposable aspiration device, as the premier product for this procedure.

Menstrual Disorders: Office visits for menstrual disorders have risen significantly in the last five years. There are three main classes: abnormal uterine bleeding, the absence of a menstrual cycle, and a painful menstrual cycle. More than 50 percent of women experience pain associated with their menstrual cycle⁹. A comprehensive differential diagnosis of this condition often includes laparoscopy.

Abnormal uterine bleeding is common in women approaching menopause. The standard diagnostic process involves a physical examination, blood tests, pelvic ultrasound and endometrial biopsy, where the CSI Pipelle is used.

Anatomic causes of abnormal uterine bleeding, including benign tumors that are found in about 50 percent of women over 35¹⁰, are identified through laparoscopic or hysteroscopic examination. Operative hysteroscopy is often performed to remove benign tumors.

Hysteroscopy is performed either in the physician's office or at the hospital. Diagnostic hysteroscopy provides a direct view of uterine cavity abnormalities before treatment. The equipment required includes a scope, a light source and a mechanism to distend the uterus. Operative hysteroscopy is usually performed in hospitals or at outpatient surgical facilities.

CSI offers an array of diagnostic hysteroscopy products including a fully integrated system with light source, camera and monitor for office use, and a variety of hysteroscopes. CSI also markets Hyskon, a solution used to distend the uterus.

⁹[Rapkin A. Pelvic Pain and Dysmenorrhea. In Berek ed., Novak's Gynecology, 12th Edition. Baltimore: Williams & Wilkins, 1996; 408. ]
¹⁰[Hillard P. Benign Diseases of the Female Reproductive Tract: Symptoms and Signs. In: Berek JS ed., Novak's Gynecology, 12th Edition. Baltimore: Williams & Wilkins, 1996; 408.]

Vaginitis: The signs of vaginitis are redness, swelling and discharge caused by an infection or disturbance in the vaginal ecosystem mainly due to bacterial vaginosis (BV), Candidiasis (yeast), and Trichomoniasis.

Apart from physical discomfort, the consequences of yeast infections are relatively benign. BV and Trichomoniasis infections, however, can lead to serious consequences. BV has been associated with early pregnancy loss, preterm delivery, premature rupture of membranes, and postpartum endometritis as well as post surgical infections and pelvic inflammatory disease. Trichomoniasis is linked to postoperative infection, preterm delivery and premature rupture of membranes. The differential diagnosis of vaginitis includes evaluation of the discharge through pH measurement and determina-tion of the presence or absence of amines.

In 1998, CSI introduced FemExam pH and Amines TestCard, a point of care diagnostic test used to differentiate these infections. The card objectively indicates elevated pH and the presence of amines, two of the four criteria used to diagnose BV. When positive, these two criteria provide a presumptive diagnosis of BV. During 2000, the American Medical Association created a specific reimbursement code for amines testing to supplement the existing code for pH testing. The Health Care Financing Administration has set a suggested reimbursement rate.

Female Genital Symptoms: Most cases of Female Genital Symptoms relate to the human papilloma virus (HPV), which is the most common sexually transmitted viral infection in the United States. Manifestations of HPV include genital warts and precancerous conditions of the cervix and the vagina. Diagnosis is through colposcopic inspection, and where indicated, biopsy. There are no known cures. Treatment regimens include keratolytic agents that promote skin shedding, immunotherapy and surgical procedures such as cryosurgery, electrocautery (LEEP) and laser therapy. CSI offers both electrosurgical and cryosurgical equipment for office-based treatment of differing stages of the infection.