Uterine fibroids are non-cancerous growths that develop in the muscular wall of the uterus or cervix, and are believed to occur in up to 25 percent of women of child-bearing age. The growths can cause heavy menstrual bleeding (menorrhagia), pressure and bulk-related symptoms and significant pain. Traditional treatments for fibroids include pharmaceutical therapy, hysterectomy or myomectomy (the surgical removal of fibroids from the uterus). Uterine fibroids are the most frequent indication for hysterectomy among pre-menopausal women.
UFE is a less-invasive procedure performed under local anaesthetic, using a small catheter (medical tube) passed through a small incision in the groin into the uterine artery. When the catheter reaches the uterine artery, tiny particles are released into the artery which flow to the fibroids, blocking the blood flow thereby starving the fibroid.
UFE has been determined as safe and effective by IPAC. The treatment offers a less-invasive alternative to hysterectomy and myomectomy that generally spares the uterus in women with symptomatic uterine fibroids. Moreover, the average length of hospital stay following the procedure is one night, compared with a typical post-hysterectomy hospital stay of two to three days. It has been estimated that, to date, around 50,000 UFE procedures have been performed globally.
Clinicians have also welcomed the IPAC recommendation. "We have treated over 1,000 patients with uterine fibroid embolization, with a complication rate significantly less than hysterectomy and success rates of over 85 percent," said Woodruff Walker, M.D., Consultant Interventional Radiologist at the Royal Surrey County Hospital, United Kingdom. "In addition, UFE takes approximately one hour to perform and allows patients to return to normal activity in about two weeks."
Dr. Walker is leading a 10-year trial of uterine fibroid embolization, due to be completed in 2006.
Boston Scientific has developed the Contour SE™ embolic agent and the Renegade Hi-Flo™ which are used by a growing number of interventional radiologists in the UFE procedure.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, the Company's overall business strategy, and other factors described in the Company's filings with the Securities and Exchange Commission.