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Approval of LifePearl® Microspheres as a Class III device in Europe

19/01/2018 - Leuven, Belgium

Terumo Europe N.V, announces the approval of LifePearl Microspheres as a Class III device in Europe.  This approval also expands the loadable chemotherapeutic drugs to include Idarubicin and Epirubicin.

LifePearl® class III device is used in the treatment of primary and secondary liver cancer and it comprises a range of microspheres that are biocompatible, hydrophilic, precisely calibrated and capable of loading and releasing chemotherapeutic agents in a controlled manner.

Since its launch in 2015, LifePearl® microspheres have been used in approximately 8,000 TACE procedures in Europe, Middle East and Africa.  LifePearl has five publications in various scientific journals and multiple presentations in Interventional radiology congresses.

A recent study demonstrated that amongst 11 anticancer drugs used in trans-arterial chemoembolization, Idarubicin is the best in vitro candidate drug for this treatment based on three HCC cell lines1. Due to its high lipophilicity, Idarubicin penetrates cell membranes more efficiently than other anthracycline compounds.

The recent approval to load additional chemotherapeutic agents into the LifePearl® device is providing more treatment options for interventional radiologists performing Drug-Eluting Microspheres TACE (DEM-TACE) procedures.  The LifePearl® device are currently the only Drug-eluting-Microspheres CE Marked as a Class III device with capability of loading four chemotherapeutic agents: Doxorubicin, Idarubicin, Epirubicin and Irinotecan.

Prof Boris Guiu, from CHU Montpellier, France said: "Approved CE mark for LifePearl® loaded with Idarubicin is a first and important step towards an optimized regimen for TACE of HCC in daily practice. LifePearls® can load completely and fastly idarubicin, and provides prolonged release. This is of particular importance given the greater efficacy of Idarubicin on HCC cancer cell lines, as compared to other drugs including doxorubicin and Epirubicin".

About Terumo Corporation

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over US $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.

 

1Screening of Anti-Cancer Drugs for chemo-embolization of hepatocellular carcinoma: Boulin M, et al., Anticancer Drugs 2011, 22:741-8