HAIFA, Israel, March 21 /PRNewswire/ -- InSightec announced today that the company has completed treatment of the final patient in a post-marketing study to evaluate the efficacy of its ExAblate 2000 in treating uterine fibroids in African-American women. This study is an element of the FDA's commercial approval for ExAblate in October 2004.
According to the U.S. National Institutes of Health, at least 25 percent of women, or thirteen million women in U.S., aged 25-50, suffer from uterine fibroids and African-American women are three to five times more likely to develop the tumors than their Caucasian counterparts. This study was initiated to confirm the efficacy of the ExAblate 2000 treatment in African American women, as they tend to have more severe uterine fibroids.
Following an expedited Pre-Market Approval (PMA) review, the U.S. Food and Drug Administration in October 2004 approved ExAblate 2000 for commercial use in patients with uterine fibroids. As part of the PMA approval order, InSightec reports safety and efficacy results to the FDA on each of the ongoing clinical studies every six months. The ExAblate 2000 is being used in 30 sites worldwide and has treated over 1500 women with uterine fibroids.
In addition to the 30 African-American patients treated in the pre-approval study 75 patients were treated in this post-PMA approval study focused on African-American women, and will be followed up for a period of 36 months. This study, tailored to the African American population, will produce some of the first data of its kind regarding the non-invasive treatment management of uterine fibroids of this high risk segment of population with the ExAblate system.
"ExAblate 2000 has given women a new non-invasive, outpatient treatment option for a condition that previously required invasive surgery and long recovery times," Dr. Phyllis Gee, an Ob/GYN surgeon at the Dallas site who is participating in the study said. "Additional studies and data will hopefully continue to add to our body of knowledge about this revolutionary treatment option."
A total of six sites participated in this study: Brigham and Women's Hospital, Boston, Mass.; Virtua Health Hospital, Vorhees, NJ; University MRI, Boca Raton, Florida; Beverly Tower Wilshire Advanced Imaging Center Radnet Radiology , Los Angeles, Ca.; Lahey Clinic, Burlington, MA, Tx and ExAblate of Dallas, Plano, Tx.
About ExAblate 2000
The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved system to use the breakthrough MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 EU's Information Society Technologies grand prize for The Wall Street Journal's 2004 Technology Innovation Awards, and Advanced Imaging's 2005 Solutions of the Year.
Uterine fibroids are benign growths in the uterus that affect approximately 13 million women of childbearing age in the U.S. Each year approximately 200,000 women have hysterectomies, to treat uterine fibroids, requiring several days of hospitalization and extensive recovery time. The ExAblate 2000 is a non-invasive, outpatient procedure using MR-guided focused ultrasound to thermally ablate (destroy) tumors in the uterus. For women this means no hospital stay and only 1-2 days of recovery as opposed to the one week (UAE); two weeks (myomectomy); or six weeks (hysterectomy) usually associated with treatment of this condition.
Contact Information InSightec Ltd. www.insightec.com Tel: +972-4-813-1313 Email: info@insightec.com For media inquiries, contact: Fern Lazar Lazar Partners, Ltd. Tel: +1-(212)-867-1762 Email: flazar@lazarpartners.com
InSightec Ltd.CONTACT: Contact Information InSightec Ltd., www.insightec.com, Tel:+972-4-813-1313, Email: info@insightec.com; For media inquiries, contact:Fern Lazar, Lazar Partners, Ltd., Tel: +1-(212)-867-1762, Email:flazar@lazarpartners.com
