Oct 7 2009
BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere” or the “Company”) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – reports the publication of a study in the October 2009 issue of the Journal of Vascular Interventional Radiology in which the authors conclude that uterine artery embolization (UAE) compares favorably to laparoscopic occlusion of uterine arteries in the treatment of uterine leiomyomas (fibroids) in cases where hysterectomy or myomectomy are not options.
The article, entitled Uterine Artery Embolization versus Laparoscopic Occlusion of Uterine Arteries for Leiomyomas: Long-term Results of a Randomized Comparative Trial, was authored by Kirsten Hald, MD, Hans Jorgen Noreng, MD, Olav Istre, MD, PhD and Nils-Einar Klow, MD, PhD of the Departments of Obstetrics and Gynecology and Radiology, Ulleval, Oslo University Hospital, Norway. In the trial, 66 women with uterine leiomyomas were randomized to receive either UAE or laparoscopic occlusion of the uterine artery, and 58 patients received treatment. Contrast-enhanced magnetic resonance (MR) imaging was performed before treatment and after six months. Median follow-up time was 48 months.
According to the study authors, “Recurrence rate was significantly lower after UAE than after laparoscopic treatment. Larger volume reduction and more complete devascularization of leiomyomas were found after UAE treatment and among patients with no recurrence.”
Clinical failure and symptom recurrence occurred in 14 patients after laparoscopy (48%) and in five patients (17%) after UAE>
“This independent, peer-reviewed study demonstrates again the importance of uterus-sparing UAE/UFE as an efficacious treatment alternative for properly selected women suffering from fibroids,” said Richard Faleschini, president and CEO of BioSphere Medical. “Until recently, there has only been very short-term data available regarding the laparoscopic occlusion of the uterine artery in the treatment of fibroids, but this longer-term study demonstrates a lack of durability when compared with UAE. We believe that the results of this study further support the Level A recommendation of UFE by the American College of Obstetricians and Gynecologists (ACOG) announced last August, and are added to the now large body of data that shows UFE to be an excellent therapeutic alternative for properly selected women with symptomatic fibroids. We look forward to disseminating the results of this study to the targeted physicians who refer patients for UFE and perform the procedure.”
Source: BioSphere Medical, Inc.
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