CeloNova has announced the US FDA 510(k) clearance expanding the indication for Embozene microspheres to include the treatment of uterine fibroids.
Embozene received the CE mark in November 2005, including clearance for use in uterine fibroid embolization. The product received initial FDA clearance in December 2008 for the treatment of arteriovenous malformations and hypervascular tumours.
“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 Linda Bradley, an internationally recognised gynaecologic surgeon and director of The Fibroid and Menstrual Disorders Center and director of Hysteroscopic Services at Cleveland Clinic in Cleveland, USA. “Research has shown that many women want a fibroid treatment option that is minimally invasive and uterus-sparing, and embolization provides an excellent option.” Bradley was quoted in a press release from the company.
“The FDA’s clearance of Embozene for uterine fibroid embolization provides continuing support to interventional radiologists and obstetricians and gynaecologists 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.