Terumo Europe N.V. is pleased to announce the launch of BioPearl™ microspheres, the first resorbable drug-eluting microspheres. We are continuing our commitment to advancing TACE by adding our latest innovation and to expanding your TACE therapeutic options. BioPearl™ microspheres are designed to combine the confidence from the drug-eluting microspheres technology and the benefits of a resorbable agent.
TACE is the guideline-recommended, first line treatment of patients with intermediate-stage HCC¹-⁶ and DEM-TACE provides a standardized treatment approach1,2,7. However, with well-established TACE techniques, signs of liver injury and hepatic insufficiency are the most common adverse effects⁸ while liver function must be preserved to safely perform potential follow up surgery, systemic or intra-arterial locoregional treatments⁹.
BioPearl™ microspheres have been designed to allow progressive blood flow restoration¹⁰ and lesion access, offering more opportunities for future intra-arterial treatments. Its degradation is driven by the presence of an aqueous media allowing a continuous degradation process¹¹.
BioPearl™ microspheres also bring the confidence of the embolic effect and sustained drug release from the drug-eluting microspheres technology.
“I’m really excited about the launch of BioPearl™ microspheres.” said Ghada Farah, Senior Vice President TIS EMEA. “Over the years, we have been continuously investing in the development and improvement of the TACE treatment through innovations and clinical data generation. We are now making Terumo’s latest innovation in TACE treatment available to TACE eligible patients in Europe – enabling healthcare providers to open new horizons in treating HCC.”
To learn more about BioPearl™ microspheres – the latest addition to our Advanced TACE portfolio – click here
For more information
Name: Olivier Sophie
Title: Marketing Manager Interventional Oncology EMEA
About Terumo Europe
Terumo Europe N.V. 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, Hospital Care Solutions, Cardiovascular and Life Care Solutions. 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.
About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 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 supporting 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 such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
DISCLAIMER:
Intended Purpose: BioPearl™ microspheres are indicated for embolization of blood vessels supplying primary-hypervascular tumours or metastases in the liver. Note: BioPearl™ 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. BioPearl™ microspheres are compatible with doxorubicin, epirubicin, and idarubicin. BioPearl™ microspheres can be drug loaded prior to embolization and then, as a secondary action, elute a local, controlled, and sustained dose to the targeted tumour sites after embolization. BioPearl™ 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 BioPearl™ devices is not cleared or approved in the USA by the Food and Drug Administration. BioPearl™ microspheres are not approved in Canada. Please contact your Terumo local sales representative for more information. BioPearl™ microspheres are manufactured by MicroVention and exclusively distributed by Terumo Europe NV in EMEA region. All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Refer to Instructions for Use for Contraindications, Warnings and Precautions.
©2023 Terumo Corporation. CE0297
Manufacturer: MicroVention Europe SARL - 30 bis, rue du Vieil Abreuvoir - 78100 Saint-Germain-en-Laye - France -
Tel: +331 39 21 77 46
Distributor: Terumo Europe N.V. - Interleuvenlaan 40 - 3001 Leuven - Belgium - Tel: +32 16 38 12 11
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2. Vogel A et al. Ann Oncol 2018;29 (suppl 4):iv238–iv255;
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7. Varela M et al. J Hepatol 2007;46:474–481;
8. Mohamed A S Kohla et al Predictors of hepatic decompensation after TACE for hepatocellular carcinoma BMJ Open Gastro 2015;2:e000032. doi:10.1136/ bmjgast-2015-000032
9. A Vogel et al Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Annals of Oncology 29 (Supplement 4): iv238–iv255, 2018 doi 10.1093/annonc/mdy308
10. Data on file – TR18-1748, BioPearl liver studies
11. BioPearl™ IFU: IFU100873 Rev. B 2020-03
