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EROS-CTD™ Female Sexual Therapy Device Approved By FDA For Female Sexual
Dysfunction (FSD) UroMetrics® 05/03/2000
Summary: The EROS-CTD™ (clitoral therapy device) has been approved by the U.S. FDA as a prescription device to treat female sexual dysfunction (FSD). The
UROS-CTD™ is designed to treat forms of FSD caused by inadequate blood flow to the genitalia by providing suction directly to the clitoris, causing engorgement. The FDA-approved indications for
EROS-CTD™ are that it improves sensation, vaginal lubrication, orgasm and overall sexual satisfaction.
Press Release: Atlanta, Georgia and St. Paul, Minnesota, May 3, 2000
- UroMetrics Inc. announced today at the American Urological Association Conference that the U.S. Food and Drug Administration has granted market clearance for the EROS-CTD™ (clitoral therapy
device) treatment as a prescription device to treat female sexual dysfunction (FSD).
Designed to treat forms of FSD caused by inadequate blood flow to the genitalia, EROS-CTD™ safely and non-invasively provides
gentle suction directly to the clitoris, causing engorgement. The FDA-approved indications for EROS-CTD™ are that it improves sensation, lubrication, orgasm and overall satisfaction.
FSD, a disease recognized by the National Institutes of Health, affects more
than 43 percent of American women (about 40 million) to some degree. The majority, but not all, of women with FSD are postmenopausal (due to hormonal changes following menopause). Women with diabetes, spinal cord injuries, or cardiovascular problems such as hypertension, high cholesterol or pre-existing heart disease, and women on anti-depressants or blood pressure medications tend to experience FSD more frequently.
"Sexual dysfunction is actually more common in women than men," said Dr.
Kevin Billups, the Minneapolis/St. Paul urologist who specializes in male and female sexual health and who conducted clinical trials on EROS-CTD™ with Dr. Irwin Goldstein, professor of urology, Boston University School of Medicine. "EROS-CTD™ is the first product on the market to effectively treat female patients complaining of reduced genital sensation, vaginal lubrication, ability to achieve orgasm and sexual satisfaction," Dr. Billups said. "It is an ideal treatment for female arousal disorders."
The EROS-CTD™ was evaluated in a two-center pilot study of pre- and post-menopausal women with complaints of Female Sexual
Arousal Disorder (FSAD), and pre- and post-menopausal women with no sexual function complaints. After
using the device, 100 percent of women with FSAD said the EROS-CTD™ improved their sexual sensation. Eighty percent noted increased sexual satisfaction and 73 percent experienced improved lubrication. Clinical studies have shown no adverse side effects from use of the EROS-CTD™.
"The results of the study were significant," said Dr. Billups. "With this kind of improvement, physicians can
finally offer a solution to their patients."
Several additional clinical trials are being conducted in the United States,
France, Norway and Italy to further evaluate EROS-CTD effectiveness. Dr. Philip Sarrel, a preeminent gynecologist with Yale University, is currently conducting one such clinical trial.
The EROS-CTD™ is available by prescription only in the United States. The EROS-CTD™ is also CE marked and available
internationally in Australia, France and the United Kingdom. AmeriSource, a national drug wholesaler, will make EROS-CTD™ available to its network of hospitals, clinics and pharmacies in the near future.
"We've been receiving great interest at the conference from hundreds of physicians who will now be able to write prescriptions
for the new device," said UroMetrics president Philip Messina.
"This is a product category we've never seen before," said Glen Faust,
managing director of Universal Sales Associates, a direct marketing firm specializing in gynecological and urological products. "Initial responses from physicians have been extremely favorable. We can see the excitement in doctors' eyes when we introduce the EROS-CTD™." Faust estimates that as many as two million women could be using the product within two years.
SOURCE: UroMetrics®
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