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BioPearl™, the first biodegradable drug eluting Microspheres, received CE mark

28/04/2020 - LEUVEN, BELGIUM

Terumo Europe N.V. today announced that BioPearlTM Microspheres received CE Mark, making it an innovative new option for patients eligible for loco-regional embolization of target artery blood supply to liver cancer. BioPearlTM Microspheres, the next generation of drug eluting microspheres, are designed to preserve post-TACE target artery access, opening up the potential for cyclic treatment1,2.


"The availability of BioPearlTM Microspheres is an important milestone in Interventional Oncology as it is the first biodegradable drug-eluting microsphere loadable with 3 chemotherapeutic drugs (doxorubicin, idarubicin and epirubicin). BioPearlTM may further improve patient outcomes by enabling retreatment of the same target artery." said Peter Coenen, President of Interventional Systems Terumo EMEA. "BioPearlTM Microspheres are leading the way to new opportunities with a biodegradable (TACE) by allowing future treatment options to be kept open. BioPearlTM Microspheres represent Terumo's latest innovation complementing our loco-regional treatment portfolio.

Currently, Drug-Eluting Microsphere TACE (DEM-TACE) and conventional-TACE are both used worldwide. BioPearlTM Microspheres have been designed based upon clinicians' desire to have controlled drug elution while keeping future treatment options open. BioPearlTM Microspheres could change treatment algorithms and may offer more choices for patients.

"Interventional Oncology is not a stand-alone speciality and by working with medical oncologists, we will be able to optimize current and future treatments, namely by delivering drugs directly into the tumour. Through such collaboration, we may be able to reduce the dosage and improve the toxicity profile of anticancer drugs and ultimately improve the field." said Pr. Thierry De Baere from Institute Gustave Roussy in Villejuif - France. "BioPearlTM drug eluting Microspheres and its degradation profile is a significant next step toward enhancing localized drug delivery and hopefully improving patient outcomes".

 

For more information
Sophie Olivier
Marketing Manager Oncology
Sophie.olivier@terumo-europe.com

 

Data on file - TR18-174B. BioPearlTM liver studies

Data on file TR-18 – 174C BioPearlTM liver studies

 

About Terumo Europe

Terumo Europe is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA. www.terumo-europe.com

About Terumo Corporation

Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for nearly 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide, to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been bolstering healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Disclaimer

INTENDED USE/INDICATIONS:

    • BioPearlTM Microspheres are indicated for embolization of blood vessels supplying primary-hypervascular tumors or metastases in the liver.
    • Note: BioPearlTM Microspheres can be loaded with chemotherapeutic drugs. When used for drug loading, drug loading should be done under a physician's direction, choice and responsibility, based on type and dose of drug most beneficial to the patient.
    • The BioPearlTM microspheres are compatible with Doxorubicin, Epirubicin, and Idarubicin, which can be loaded prior to embolization and then, as a secondary action, elute a local, controlled, and sustained dose to the tumor after embolization.
    • BioPearlTM-Microspheres are indicated for embolization according to the IFU. They may be loaded with a drug to elute a local, controlled, sustained dose of said drug to targeted tumor sites after embolization. Loading of drug should be under a physician's direction, choice and responsibility, based on type and dose of drug most beneficial to the patient.

BioPearlTM Microspheres are not available for sale in all countries. This information is provided only in respect to markets where this product is approved or cleared. The use of the BioPearlTM device in combination with drugs is not cleared or approved in the U.S.A. by the Food and Drug Administration. BioPearl Microspheres are not approved in Canada. Please contact your Terumo local sales representative for more information.

All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Refer to Instructions for Use for additional information. CE0297

Manufacturer : MicroVention Europe, 30 bis, rue du Vieil Abreuvoir, 78100 Saint-Germain-en-Laye, France

Tel: +33(0)1 39 21 77 46, Fax: +33(0)1 39 21 16 01

Distributor : Terumo Europe N.V., Interleuvenlaan 40, 3001 Louvain Belgique, Tel: +32 16 38 12 11