Gil Robert J, Bil Jacek, Kaczynski Mateusz, Milewski Krzysztof P
a Department of Invasive Cardiology , Central Clinical Hospital of the Ministry of the Interior and Administration , Warsaw , Poland.
b Polish Academy of Science , Mossakowski Medical Research Centre , Warsaw , Poland.
Expert Rev Med Devices. 2017 Apr;14(4):279-284. doi: 10.1080/17434440.2017.1318058. Epub 2017 Apr 19.
Coronary bifurcation lesions pose therapeutic challenges during percutaneous coronary interventions. Dedicated bifurcation stents are one of the treatment options available. Areas covered: This paper will analyze the results of the BiOSS (Bifurcation Optimization Stent System) Clinical Program with a special focus on the cobalt-chromium BiOSS LIM C stent which has recently been introduced into the market (CE 2016). The stent is characterized by a strut thickness of 70 µm and sirolimus concentration of 1.4 µg/mm. Expert commentary: The first BiOSS stent was a bare metal one, but shortly after a paclitaxel-eluting version was introduced - BiOSS Expert stent (CE 2010). After acceptable results of BiOSS Expert stent were obtained in registries as well as in the randomized clinical trial POLBOS I, a way for improvement was to change paclitaxel into the - olimus drug. Sirolimus has been chosen and the BiOSS LIM stent was developed (CE 2012). BiOSS LIM is the dedicated bifurcation stent with stainless steel platform that releases sirolimus (1.4 µg/mm) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids. Nevertheless, the idea to reduce late lumen loss and as a result TLR rate by using thinner struts appeared. Therefore, presently first-in-man registry with BiOSS LIM C is ongoing.
冠状动脉分叉病变在经皮冠状动脉介入治疗中带来了治疗挑战。专用分叉支架是可用的治疗选择之一。涵盖领域：本文将分析BiOSS（分叉优化支架系统）临床项目的结果，特别关注最近已进入市场（2016年CE认证）的钴铬合金BiOSS LIM C支架。该支架的特点是支柱厚度为70微米，西罗莫司浓度为1.4微克/毫米。专家评论：第一代BiOSS支架是裸金属支架，但不久后推出了紫杉醇洗脱版本——BiOSS Expert支架（2010年CE认证）。在注册研究以及随机临床试验POLBOS I中获得了可接受的BiOSS Expert支架结果后，改进的方法是将紫杉醇换成-olimus类药物。选择了西罗莫司并开发了BiOSS LIM支架（2012年CE认证）。BiOSS LIM是一种专用分叉支架，其不锈钢平台从由乳酸和乙醇酸共聚物组成的可生物降解涂层表面释放西罗莫司（1.4微克/毫米）。然而，出现了通过使用更薄的支柱来减少晚期管腔丢失并因此降低靶病变血运重建率的想法。因此，目前正在进行BiOSS LIM C的首例人体注册研究。
