Brentwood Medical Obtains FDA Approval for New Medical Device
12/11/2012 8:48:40 AM
A medical company with a pilot plant in Brentwood recently became the first company worldwide to obtain U.S. Food and Drug Administration approval for surgically treating uterine fibroids. Halt Medical spent nearly a decade testing and developing the medical device, called Acessa, before receiving an FDA clearance last month. The human clinical trial for Acessa involved 137 patients of various racial backgrounds at 11 different sites in the United States, Mexico and Guatemala, according to Halt CEO Jeff Cohen. "It is big news. We are still celebrating," said Cohen last week. "We are thrilled to be in a position to fundamentally improve women's health care." According to Cohen, Acessa uses radio-frequency energy to heat the tissue and destroy the uterine fibroids, which are later absorbed by the surrounding tissue. This technology allows doctors to use a minimally invasive surgery rather than do a hysterectomy, which was usually used to remove the fibroids. Dr. Don Galen, a San Ramon-based gynecologist, said among the advantages of Acessa is that it is an outpatient procedure, it involves less discomfort for patients because there is no large incision, and it doesn't require removing the majority of the uterine tissue. "It would allow us to actually treat virtually all of the fibroids in the uterus in any location in the uterus because of the high-resolution ultrasound that was used as part of the procedure," Galen said. In the United States, 7.5 million women suffer from symptomatic uterine fibroids and only 300,000 women have a procedure done to cure it, Cohen said. "Most women would rather suffer with it than have a hysterectomy," he said. Among the common symptoms of uterine fibroids is excessive bleeding, painful sexual intercourse, incontinence, infertility and pain. Through the Acessa trial, women saw a significant reduction in symptoms ï»¿during the first three to six months, and 98 percent of them would recommend it to their friends. "Often, these women only wear black, don't leave their houses or don't have intercourse," Cohen said. "We significantly reduced their bleeding. It changes your life. You can become a prisoner of it (fibroids)."
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