FDA Approves PMA Application for New Therapy to Treat Excessive Menstrual Bleeding, the Second-Leading Indicator of Hysterectomy.

MENLO PARK, Calif.--(BW HealthWire)--Dec. 15, 1997--

Eight-Minute, Minimally Invasive, Outpatient

Alternative Performed under Local Anesthesia

The ThermaChoice(TM) Uterine Balloon Therapy(TM) system is now approved for marketing by the U.S. Food and Drug Administration (FDA) for the treatment of excessive menstrual bleeding (menorrhagia), due to benign causes in pre-menopausal women who have completed childbearing. Menorrhagia is a debilitating condition that affects approximately 22% of all menstruating women. ThermaChoice is intended to reduce excessive bleeding to normal menstruation levels or less. Gynecare(TM), Inc., which operates as a division of Ethicon, Inc., a Johnson & Johnson (NYSE:JNJ) company, developed the therapy.

Excessive menstrual bleeding accounts for more than 30% of the 600,000 hysterectomies performed in the United States each year and is a common cause of iron deficiency anemia. Hysterectomy, the second most frequently performed female surgical procedure in the United States (surpassed only by Cesarean section), is the most common surgical treatment for menorrhagia. Hysterectomy provides a cure for menorrhagia, but is often accompanied by numerous physical and psychological effects. Another surgical therapy -- endometrial ablation using a laser or electrosurgical probe -- is available, but is not broadly used due to the high degree of surgical skill required to perform the procedure. Hysterectomies performed to treat excessive menstrual bleeding cost the U.S. healthcare system an estimated $1.5 billion annually.

"Hysterectomy is a costly, major surgical procedure, requiring general anesthesia and four to six weeks off from work," said clinical investigator Brian Walsh, M.D., chief of the division of surgical gynecology, Brigham and Women's Hospital, Boston, Mass. "Uterine Balloon Therapy is a far simpler approach than hysterectomy. It typically takes less than half an hour including the administration of local anesthesia, with only approximately eight minutes necessary for the therapy itself. The patients I treated in the clinical trial were pleased with the outcome of the procedure and were able to resume normal activity in 24 hours."

One-year follow-up results from the U.S. clinical trials indicate that the ThermaChoice procedure was successful in 81% of the 125 patients treated with ThermaChoice and followed for 12 months. Clinicians typically define success in treating excessive menstrual flow as a reduction to normal bleeding levels or less. No intra-operative complications were observed during the trials and only minor post-operative effects were noted: 2.1% of patients experienced probable endometritis and urinary tract infection. Minor post-operative cramping was typically managed with an anti-inflammatory pain reliever.

"I did not want to have a hysterectomy to treat my excessive menstrual bleeding," said Robin Katsaros, a California patient treated during the ThermaChoice U.S. clinical trials. "I felt practically no pain during the ThermaChoice procedure and was able to go home the same day. The amount of blood loss during my period has decreased significantly, allowing me to lead an active lifestyle every day of the month. The most comforting thought to me is that I still have my uterus."

The ThermaChoice procedure, which is expected to cost between US$2,500 and $3,000, uses heat to remove the endometrial lining of the uterus, the primary source of menstrual bleeding. A balloon catheter is inserted vaginally through the cervix and into the uterus. The balloon is inflated with sterile fluid, which is then heated to 87 degrees Celsius (188 degrees Fahrenheit) for eight minutes. After the treatment cycle is completed, the balloon is deflated and the balloon catheter is withdrawn and discarded.

"ThermaChoice offers women a minimally invasive treatment that will significantly reduce bleeding with minimal time away from work and their normal daily routine," said ThermaChoice clinical investigator, Tanya Spirtos, M.D., clinical professor, Stanford University School of Medicine, Palo Alto, Calif. "With ThermaChoice, there are fewer complications and less pain as compared with other surgical treatments such as hysterectomy. Additionally, women do not have to experience the psychological or physical impact of having their uterus removed, an organ often associated with a woman's femininity."

Physicians and patients who are interested in learning more about ThermaChoice may telephone [phone]. -0- Note to Editors and Producers:

Visuals of ThermaChoice are available in photo print, slide or .tif file format.

A Video News Release and B-roll will be broadcast via satellite at the following four times and coordinates:

-- Monday, Dec. 15 at 10 a.m. EST/7 a.m. PST; Ku-Band / SBS-6 / Transponder 11 / Audio 6.2 & 6.8; downlink frequency 11.970 MHz (Horizontal).

-- Monday, Dec. 15 at 1 p.m. EST/10 a.m. PST; C-Band / Galaxy 9 / Transponder 22 / Audio 6.2 & 6.8; downlink frequency 4140 MHz (Horizontal).

-- Tuesday, Dec. 16 at 10 a.m. EST/7 a.m. PST; C-Band / Galaxy 9 / Transponder 1 / Audio 6.2 & 6.8; downlink frequency 3720 MHz (Vertical).

-- Tuesday, Dec. 16 at 1 p.m. EST/10 a.m. PST; Ku-Band / SBS-6 / Transponder 13 / Audio 6.2 & 6.8; downlink frequency 12.019 MHz (Horizontal).

An Audio News Release will be broadcast via satellite at the following three times and coordinates:

-- Monday, Dec. 15 at 3:08 p.m. EST/12:08 p.m. PST; AP Network News / Main Audio Line.

-- Tuesday, Dec. 16 at 4:08 a.m. EST/1:08 a.m. PST; AP Network News / Main Audio Line.

-- Tuesday, Dec. 16 at 4:45 a.m. EST/1:45 a.m. PST; ABC Radio / Satcom C_5 / Transponder 23 / SEDAT Channel 15.

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The Ethicon, Inc. subsidiary of Johnson & Johnson is the world's leading marketer of surgical sutures and, through its Mitek Products division, suture anchors. The company also markets a full line of surgical mesh products and electrosurgery devices. Through its recently established women's health division, Ethicon, Inc. markets Interceed(TM), a leading surgical adhesion barrier, and products for the treatment of female incontinence. In November 1997, Gynecare and Johnson & Johnson completed a stock-for-stock merger of Gynecare with Johnson & Johnson. Gynecare will operate as a division of Ethicon, Inc., a Johnson & Johnson company headquartered in Somerville, New Jersey.

The ThermaChoice UBT System is a thermal ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. Contraindications include patients who are pregnant or who want to become pregnant; patients with a history of allergy or sensitivity to latex; patients with uterine cancer or pre-malignant change of the endometrium; patients with conditions contributing to weakness of the myometrium; patients with active genital or urinary tract infection; and patients with an intra-uterine device in place. Endometrial ablation using ThermaChoice is not a sterilization procedure, and pregnancy after ablation can be dangerous for both mother and fetus. Endometrial ablation using ThermaChoice should be performed only by medical professionals experienced in procedures within the uterine cavity. The safety and effectiveness of ThermaChoice has not been fully evaluated in patients with atypical uterine cavity size, with sub-mucosal myomas and certain other conditions, who have undergone previous endometrial ablation procedures or who are post-menopausal. Events that have been reported following completion of the procedure include mild to moderate cramping and pelvic pain for most patients, which may be severe during the intra-operative period and immediate post-operative period, nausea and vomiting, and endometritis, perforation and hematometra. Consult the package insert for full information about use. -0-

Note to Editors: Gynecare, ThermaChoice and Uterine Balloon Therapy are trademarks of Gynecare, Inc. Interceed is a trademark of Ethicon, Inc.

CONTACT: Schwartz Communications

Hallie Loring/Hope Freundlich, 415/512-0770

Lloyd Benson, 781/684-0770