SAN ANTONIO--(BUSINESS WIRE)--CeloNova BioSciences, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance expanding the indication for their leading Embozene® microsphere product to include the treatment of uterine fibroids.
This approval will give women suffering from uterine fibroids an important treatment option performed by interventional radiologists called uterine fibroid embolization (UFE).
In the United States, at least 600,000 women every year have hysterectomies – the surgical removal of the uterus – according to the Centers for Disease Control and Prevention.1 Many of those major surgeries, some 232,000, are performed on women who suffer from uterine fibroids, which are common benign tumors made of muscle and connective tissue from the wall of the uterus.
Fibroids can range greatly in size and can cause excessive or painful bleeding during menstruation, frequent urination, low back pain and infertility. According to the Office of Women’s Health, U.S. Department of Health and Human Services, 20% to 80% of women develop fibroids by age 50.2
The UFE procedure offers significant advantages over hysterectomy, including a minimally invasive procedure with reduced recovery time (typically performed as an outpatient procedure) and lower medical costs. It is estimated that more than 24,000 UFE procedures3 are conducted annually in the U.S., with that number predicted to grow considerably as awareness grows about this effective treatment.
“The symptoms of uterine fibroids can cause significant impact in a patient’s quality of life and are the leading cause of hysterectomy in America,” said Dr. Linda Bradley, MD, an internationally recognized gynecologic surgeon and Director of The Fibroid and Menstrual Disorders Center and Director of Hysteroscopic Services at Cleveland Clinic in Cleveland, OH.4 “Research has shown that many women want a fibroid treatment option that is minimally invasive and uterus-sparing, and embolization provides an excellent option.”5
“The FDA’s clearance of Embozene® for uterine fibroid embolization provides continuing support to interventional radiologists and OBGYNs working in tandem to offer women an alternative to hysterectomy. This clearance allows us to focus our embolic platform to provide women relief for symptomatic fibroids,” said Dennert O. Ware, Chairman of the Board of CeloNova BioSciences.
Embozene® microspheres are tiny spheres that shrink the fibroid by stopping the blood flow to the growing tumor.
“Embozene® microspheres go through a sophisticated manufacturing process that ensures precisely calibrated size and shape,” said Jane Ren, Ph.D., Chief Technology Officer of CeloNova BioSciences. “They are really designed to give the interventional radiologist the highest level of confidence in performing the procedure.”
CeloNova BioSciences Embozene® microspheres received European CE mark in November 2005, including embolization for UFE. Embozene® microspheres received initial FDA clearance in December 2008 for the treatment of arteriovenous malformations and hypervascular tumors. Embozene® microspheres have been successfully used in thousands of procedures and are currently available in more than 45 countries.
About the Company
CeloNova BioSciences, Inc., headquartered in San Antonio, Texas, is a global medical device company that develops, manufactures and markets a family of Interventional Cardiology and Endovascular products. Our products are developed and manufactured in Carlsbad, California, U.S.A. and Ulm, Germany. The Company’s regional offices are located in Germany, France, United Kingdom, Netherlands and Austria. For additional information about CeloNova BioSciences, see the company website at www.celonova.com.
3. Millennium Research Group, US Markets for Transcatheter Embolization and Occlusion Devices 2014.
5. Borah JB, Nicholson WK, Bradley L, et al. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol 2013;209:319.e1-20
The CeloNova BioSciences, and Embozene® names and logos are registered to CeloNova BioSciences, Inc. All product names in any character format and/or with the trademark symbol are trademarks of CeloNova BioSciences, Inc. Distributed by CeloNova BioSciences, Inc. San Antonio, TX 78258 © CeloNova BioSciences. All rights reserved.
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