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BioPearl™ Microspheres

Resorbable drug-eluting microspheres

Description

​​​BioPearlTM microspheres are the first resorbable drug-eluting microspheres and latest innovation in your TACE therapeutic options. 

BioPearlTM microspheres have been designed to allow progressive blood flow restoration1 and lesion access, offering more opportunities for future intra-arterial treatments.

Indications: 

BioPearlTM microspheres are indicated for embolization of blood vessels supplying hypervascular primary 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.2

Characteristics

​​​Liver function is a key variable influencing survival for HCC patients receiving a TACE treatment3.  
With well-established TACE techniques, signs of liver injury and hepatic insufficiency are the most common adverse effects4. Liver function must be preserved during and after HCC TACE procedures to keep options open for any potential necessary follow up intervention: surgery, systemic or intra-arterial locoregional treatments5.  

BioPearlTM microspheres are the first resorbable drug-eluting microspheres and latest innovation in your TACE therapeutic options  
Degradation is driven by the presence of an aqueous media allowing a continuous degradation process2. BioPearlTM microspheres have been designed to allow progressive blood flow restoration and lesion access as seen in pre-clinical studies1 and early in-human experience.
​
Images With the courtesy of Prof Carlo Spreafico – Istituto Nazionale dei Tumori – Milan / Italy​
Case study, results may vary. not all patients will get the same results
​
BioPearlTM microspheres bring the confidence of the drug-eluting Microspheres technology with:  

a. A sustained chemotherapeutic drug release (in-vitro)6



b. An embolic effect1

Images with the courtesy of prof Gerd Grözinger Universitätsklinikum – Tübingen / Germany
Case study, results may vary. not all patients will get the same results​

General specifications


​Volume of microspheres​
​​2ml​


Item specifications

​​​

​BioPearlTM microspheres sizes
​Colour
​Item reference

​200µm (100-350 µm)

​Yellow

​8BP2S200

​

Enlarge table

This information is provided only in respect to markets where this product is approved or cleared. BioPearl™​ Microspheres are not 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.

All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Refer to Instructions for Use for additional information. ©2023 MicroVention, Inc. CE0297

Manufacturer: MicroVention Europe - 30 bis, rue du Vieil Abreuvoir - 78100 Saint-Germain-en-Laye - France - Tel: +33(0)1 39 21 77 46

Distributor: Terumo Europe N.V. - Interleuvenlaan 40 - 3001 Leuven - Belgium -Tel: +32 16 38 12 11​

References

​1. Data on file: TR18-174B – BioPearl Liver studies
2. BioPearl Instructions for use 2020
3. Imam Waked et al Transarterial chemo-embolisation of hepatocellular carcinoma: impact of liver function and vascular invasion. British Journal of Cancer (2017) 116, 448–454 | doi: 10.1038/bjc.2016.423 
4. 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
5. 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 
6. Data on file: Data on file: JRD20-0122

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