Terumo Europe NV announces approval of LifePearl as a Class III device in Europe

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LifePearl

This approval also expands the number of chemotherapeutic drugs that can be loaded onto LifePearl to include idarubicin and epirubicin, a press release from the company states.

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

The recent approval to load additional chemotherapeutic agents onto the LifePearl device provides more treatment options for interventional radiologists performing transarterial chemoembolization (TACE) with drug-eluting microspheres (DEM-TACE). LifePearl is currently the only drug-eluting-microsphere CE marked as a Class III device with the capability of loading four chemotherapeutic agents: doxorubicin, idarubicin, epirubicin and irinotecan, the release adds.

Since its launch in 2015, LifePearl has been used in approximately 8,000 TACE procedures in Europe, the Middle East and Africa. LifePearl has five publications in various scientific journals and multiple presentations in interventional radiology congresses, material from Terumo states.

A recent study demonstrated that amongst 11 anticancer drugs used in TACE, idarubicin is the best in vitro candidate drug for this treatment based on three hepatocellular carcinoma cell lines. Due to its high lipophilicity, idarubicin penetrates cell membranes more efficiently than other anthracycline compounds, notes the release.

Boris Guiu, from CHU Montpellier, France said: “CE mark approval for LifePearl loaded with idarubicin is a first and important step towards an optimised regimen for TACE for hepatocellular carcinoma in daily practice. LifePearl [microspheres] can completely and rapidly load idarubicin and provide prolonged release. This is of particular importance, given the greater efficacy of idarubicin on hepatocellular carcinoma cancer cell lines, as compared to other drugs including doxorubicin and epirubicin”.

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