Uterine fibroid treatment option 'safe and effective'

Nov 1 2004

Boston Scientific Corporation today welcomed an announcement by the Interventional Procedures Advisory Committee (IPAC) of the National Institute for Clinical Excellence (NICE), confirming the safety and efficacy of uterine fibroid embolization (UFE), an innovative treatment for fibroids.

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(TM) embolic agent and the Renegade Hi-Flo(TM) 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.