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Gynecare introduces thermal balloon ablation device.
2003 JUN 12 - (NewsRx.com & NewsRx.net) -- Gynecare announced that the U.S. Food and Drug Administration (FDA) has provided premarket approval (PMA) for the new Gynecare Thermachoice III Uterine Balloon Therapy System, a device indicated to treat menorrhagia due to benign causes in premenopausal women.
The new device offers greater cornual coverage and improved treatment of the lower uterine segment than the current system.
"Thermachoice has proven to deliver high patient satisfaction over the long term with minimal risk," said R. Wayne Whitted, MD, director, department of obstetrics and gynecology, University of Miami School of Medicine. "The new technology should enhance treatment outcomes for women who suffer with heavy menstrual periods."
In evaluating Thermachoice III, it was found that it allowed for more even necrosis of tissue throughout the entire endometrium.
A long-term follow-up study of women previously treated with the original Gynecare Thermachoice device confirms efficacy and patient satisfaction. The data shows that 5 years after treatment, 95% of women still reported normal bleeding or less, and 93% of women said they remained satisfied with the treatment. Overall, nearly 7 out of 10 patients avoided further surgical intervention for menorrhagia, such as hysterectomy, dilation and curretage (D&C), or repeat endometrial ablation. The 5-year follow-up data also showed no reported endometrial carcinoma among the ...
- Study Reports GYNECARE THERMACHOICE III Helps Most Women With Heavy Periods...
- Press release article from: PR Newswire November 10, 2006 700+ words
...undergoing treatment with GYNECARE THERMACHOICE* III Uterine Balloon Therapy...following treatment with GYNECARE THERMACHOICE III. The success rates in...These results show that GYNECARE THERMACHOICE III is a safe and effective...
- Gynecare, the women's health division of Ethicon, a Johnson & Johnson company....
- Newspaper article from: The BBI Newsletter July 1, 2003 700+ words
...the FDA has provided premarket approval for the Gynecare Thermachoice III Uterine Balloon Therapy System, a device indicated...causes in premenopausal women. In evaluating Thermachoice III, it was found that it allowed for more even...
- Gynecare Introduces Next Generation Thermal Balloon Ablation Device.
- Press release article from: PR Newswire May 13, 2003 700+ words
...provided Pre-Market approval (PMA) for the new GYNECARE THERMACHOICE* III Uterine Balloon Therapy System, a device indicated...of women previously treated with the original GYNECARE THERMACHOICE device confirms efficacy and patient satisfaction...
- Product Briefs.
- Magazine article from: Medical Device Week November 13, 2006 700+ words
...nine out of 10 women undergoing treatment with Gynecare Thermachoice III Uterine Balloon Therapy System to treat menorrhagia...PAC) or to no PAC following treatment with Gynecare Thermachoice III. The success rates in the groups were comparable...
- Newer version of endometrial ablation technique said to boost satisfaction.
- Magazine article from: OB GYN News Johnson, Kate July 15, 2005 700+ words
...clinical efficacy data on the Thermachoice III balloon ablation system...at the meeting focused on Thermachoice III. "My results on patient...and symptom reduction with Thermachoice III do look better than results...
- What Women Want and Don't Want When Treating Heavy Periods; New Survey Reveals...
- Press release article from: PR Newswire May 25, 2004 700+ words
...15). About Treatment with GYNECARE THERMACHOICE Uterine Balloon Therapy System GYNECARE THERMACHOICE* Uterine Balloon Therapy System...non-cancerous) causes. GYNECARE THERMACHOICE uses heat to treat the endometrium...
- New Study Shows Uterine Balloon Therapy Helps Women Avoid Hysterectomy Over The...
- Press release article from: PR Newswire May 30, 2003 700+ words
...heavy menstrual periods) with the GYNECARE THERMACHOICE* Uterine Balloon Therapy System...annually in the United States. The GYNECARE THERMACHOICE Uterine Balloon Therapy System...activity the day after treatment. GYNECARE THERMACHOICE has been used to treat more than...
- New Study Shows Endometrial Ablation Most Cost-Effective Treatment for Heavy...
- Press release article from: PR Newswire July 28, 2006 700+ words
...amp; Urology, makers of the GYNECARE THERMACHOICE* Uterine Balloon Therapy system...or repeat endometrial ablation. GYNECARE THERMACHOICE Uterine Balloon Therapy is not...company. For more information about GYNECARE THERMACHOICE, please visit http://www...
- Studies by H.O. Chapa and co-authors describe new findings in...
- Magazine article from: Women's Health Weekly June 11, 2009 700+ words
...study from the United States, "To evaluate in-office Thermachoice III endometrial ablation on subsequent dysmenorrhea and premenstrual...Menorrhagia). The researchers concluded: "In-office Thermachoice III endometrial ablation results in decreased dysmenorrhea...
- Conceptus and Gynecare to Begin Immediate Co-Promotion of Essure and...
- Press release article from: Business Wire July 27, 2004 700+ words
...allowing for use of the Essure(R) procedure with the GYNECARE THERMACHOICE(TM) Uterine Balloon Therapy System. These modifications...Birth Control performed immediately prior to treatment by GYNECARE THERMACHOICE(TM) endometrial ablation. Pregnancy after any form...
Source: HighBeam Research, Gynecare introduces thermal balloon ablation device.