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Medical Devices / Commercial Operations

Nippon Kayaku Introduces Embolic Microspheres in Japan

Jan. 31, 2014

Technology company Nippon Kayaku said Thursday it has launched the HepaSphere and Embosphere microspheres in Japan. The devices combat cancer by cutting off the arteries that feed malignant cells.

The company acquired exclusive rights to develop and market both products in Japan from Merit Medical Systems subsidiary BioSphere Medical in 2009. Japan’s Pharmaceutical and Medical Devices Agency approved the devices in June of last year.

Embosphere has been available in the U.S., EU and many countries for 12 years for use in embolyzing uterine fibroid, hypervascular tumors and arteriovenous malformations, said Merit spokesman Jim Kelly. The microspheres can compress up to 33 percent to better pass through microcatheters and may reduce problems stemming from particle fragmentation, which are common in other embolics, according to Merit.

HepaSphere is indicated for embolization of hepatocellular carcinoma or liver metastases in the EU, Canada and Japan. The microspheres, which elute doxorubicin, are capable of absorbing contrast media or saline and can be matched to a patient’s vasculature in order to optimize outcomes. HepaSphere has not been cleared for liver pathology in the U.S., where it is marketed as QuadraSphere, Kelly said.

The launch adds to the Nippon Kayaku’s oncology interventional radiology portfolio, which includes IA-call for hepatocellular carcinoma, Gelpart for transarterial embolization in hepatocellular carcinoma and Serescue to stanch bleeding from transcatheter arterial embolization. — Lena Freund

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