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Stellarex drug-coated balloon: a technology evaluation.
Expert Opinion on Drug Delivery ( IF 5.0 ) Pub Date : 2020-07-02 , DOI: 10.1080/17425247.2020.1787982
Roberto Nerla 1 , Fausto Castriota 1 , Alberto Cremonesi 1 , Antonio Micari 1
Affiliation  

The Stellarex® drug-coated balloon (DCB) is an over-the-wire dual lumen catheter with a distally premounted semi-compliant balloon, which has a low dose (2 μg/mm2 of the expanded balloon surface) paclitaxel coating. Its hybrid formulation, made of amorphous and crystalline paclitaxel combined with a polyethylene glycol excipient, provides maintenance of coating integrity and adequate drug release. This balanced combination of amorphous and crystalline paclitaxel is able to maintain drug on the surface during handling and balloon tracking, with an effective drug transfer to vessel wall in the lesion site. Clinical data associated with Stellarex balloon are growing and confirm clinical effectiveness over a long-term follow-up without any possible signal of a reduced safety for treated patients.



中文翻译:

Stellarex药物涂层球囊:技术评估。

Stellarex®药物涂层球囊(DCB)是线控双腔导管,其远端预装了半顺应性球囊,紫杉醇涂层剂量低(扩张的球囊表面2μg/ mm 2)。它的混合配方由无定形和结晶紫杉醇与聚乙二醇赋形剂结合而成,可保持涂层完整性和足够的药物释放。非晶态和结晶性紫杉醇的这种平衡组合能够在处理和球囊跟踪过程中将药物保持在表面上,并有效地将药物转移到病变部位的血管壁上。与Stellarex球囊相关的临床数据正在增长,并证实了长期随访的临床有效性,而没有任何可能降低被治疗患者安全性的信号。

更新日期:2020-08-20
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