I am pleased to announce that Nippon Kayaku (authorized distributor for Merit Medical Systems, Inc.) has received distribution and marketing authorization in Japan for Embosphere Microspheres and HepaSphere Microspheres.
The Japan Ministry of Health, Labour and Welfare held the “10th Investigative Commission about Expedited Introduction of Medical Devices, Which Are Strongly Needed in Medical Treatment” and it recommended the introduction of Embosphere and HepaSphere Microspheres to the Japan market. The recommendation was fulfilled by approval of both products in June 2013.
Embosphere Microspheres, the most clinically studied round embolic, provide consistent and predictable results for effective embolization in the treatment of uterine fibroids, hypervascular tumors, and arteriovenous malformations. Used worldwide in over 250,000 procedures since 2002, Embosphere Microspheres are the gold standard in uterine fibroid embolization, with Interventional Radiologists choosing Embosphere Microspheres in 73% of cases according to the FIBROID registry published in Obstetrics and Gynecology.
HepaSphere Microspheres are biocompatible, hydrophilic, nonresorbable, and conformable microspheres designed for controlled, targeted embolization. HepaSphere Microspheres also rapidly absorb aqueous solutions such as contrast media or saline. HepaSphere Microspheres enable physicians to optimize outcomes by more precisely matching the sphere size to the size of the targeted vasculature. In Japan, HepaSphere Microspheres are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in the following procedures:
- Embolization of hepatocellular carcinoma
- Embolization of metastases to the liver
Please visit our product pages for more information.
Product Manager, Merit Medical