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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-tools="gulangu" data-id="97917"><section><section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>据外媒报道，美敦力为旗下</span><span>首个治疗小血管病变的2.0 毫米药物洗脱支架</span><span>Remark Onyx申请到了新的独特CE认证，针对高出血风险（HBR）患者的DAPT适应症。</span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><p><p><img src="image/20201014/ba21df8de968c9e819eb55d02ca6799c_2.jpg" /></p></p><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>对于HBR患者而言，长期使用DAPT治疗方案会增加额外的风险，美敦力允许这一新的适应症允许医生在使用Resolute Onyx进行经皮冠状动脉介入治疗后，执行为期一个月的短期DAPT方案。</span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>据悉，美敦力在近2,000名HBR患者中分别用Resolute Onyx和BioFreedom DCS进行了长期的比对试验，结果在<span>重大不良心脏事件、心肌梗塞、靶血管血运重建、缺血驱动靶病变血运重建、心脏死亡、1年全因死亡</span>等标准下，Resolute Onyx的表现全面占优。这项全球研究的结果在2019年9月第31届经导管心血管治疗会议上的最新临床试验会议上分享，并已发表在《新英格兰医学杂志》上。</span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span><strong><span>Resolute Onyx 2.0 毫米药物洗脱支架</span></strong></span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>2018年，美敦力宣布Resolute Onyx获得FDA认证，这是目前市场上最小的药物洗脱支架，专用于治疗小血管病变。这款新型支架旨在帮助心脏介入医生治疗冠状动脉小血管病变患者，此类患者通常在经皮冠状动脉介入治疗中无法使用较大支架技术。</span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><p><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0bf25yaacaaajaanevpbdrpfb3wdahxaaaia.f10002.mp4?dis_k=f5979e08961fa5fa78f68a27e4359571&dis_t=1602648228" type="video/mp4"></source></video></p><p><span>关于Resolute Onyx 视频来源：美敦力官网</span></p><p><br /></p><p><span>该产品是美国获批的首款，也是目前唯一一款2.0 毫米药物洗脱支架，让医生在已有的 Resolute Onyx 4.5 毫米和5.0 毫米规格之外，获得更多的药物洗脱支架尺寸选择，能够为患者提供应用于从极小到极大冠状动脉血管、从最简单到最复杂解剖结构的治疗方案。</span></p><p><span><br /></span></p><p><p><img src="image/20201014/87f8f3d07942361489b843bea41ddeb2_3.jpg" /></p></p><p><br /></p><p><span>此外，这一支架的设计达到了药物洗脱支架的最小外径（小于1毫米），具有极佳的输送能力。输送到位后，Resolute Onyx 2.0 毫米药物洗脱支架可从2.0 毫米扩张至标示的最大扩张直径3.25 毫米。</span></p><p><span><br /></span></p><p><span>Resolute Onyx支架平台是首先并唯一使用Core Wire技术的药物洗脱支架，该技术由连续正弦波技术演变而来。连续正弦波技术是美敦力特有的支架制造工艺，用正弦波形态的一根钴合金金属丝构建支架。Core Wire技术实现了更细的支架丝，同时保持良好的支撑性和可视性。</span></p><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><strong><span>国内市场概览</span></strong><br /></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>Resolute Onyx 2.0<span>毫米药物洗脱支架</span>过审CE，意味着Resolute Onyx系列“首个能够用于直径＜2.25mm的药物洗脱支架”得到了欧盟认可，在造福患者的同时，也将为美敦力公司带来巨大的商业价值。<br /></span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section data-bgless="spin" data-bgopacity="30%"><span>可以说在下一代产品可降解支架全面普及上线以前，药物洗脱支架仍然将统治这块市场。我国冠脉支架技术发展起步时落后于发达国家，目前处于加速追赶阶段。目前国产品牌冠脉支架约占80%的国内市场，主要品牌有微创医疗、乐普医疗等，在研发方面已经取得了一定的成绩。</span></section><section data-bgless="spin" data-bgopacity="30%"><br /></section><section><span>如北京中科益安公司与中科院金属研究所合作，成功开发出了高氮无镍不锈钢药物洗脱支架。支架材料是中科院金属研究所开发，并且拥有自主知识产权的新型高氮无镍不锈钢(BIOSSN4)，其性能与美国Carpenter公司的BioDur108合金相当。</span></section><section><br /></section><section><span>高氮无镍不锈钢支架具有更薄的网丝结构，表现出更优异的柔顺性、支撑力和生物相容性。目前已经获得高氮无镍不锈钢冠脉支架的产品注册检验合格报告，并完成了冠脉支架的30例一期临床试验。中科院金属研究所还在国际上率先提出了医用金属材料生物功能化的创新概念。体内外实验结果显示，在传统316L不锈钢和L605合金中适量加入具有特定生物功能的Cu元素，支架显示出促进内皮化、抑制平滑肌细胞增殖和抗凝血等效果，为解决冠脉支架内再狭窄和晚期血栓问题提供了新的思路。</span></section><section><br /></section><section><span>2018年9月，《柳叶刀》杂志全文刊登了上海微创医疗器械公司自主研发的Firehawk(火鹰)冠脉雷帕霉素靶向洗脱支架系统在欧洲大规模临床试验(TARGET AC)的研究结果。结果显示，以微包裹槽靶向洗脱为设计特点的火鹰支架，是全球所有药物支架中最少药剂量和最小副作用的产品，兼具了裸支架的更安全优点和药物支架更有效性优点这两个看似矛盾的特性，避开了裸支架“易产生血管术后再狭窄”和药物支架“易引发晚期和极晚期血栓”各自固有的特征性缺陷。</span></section><section><span><br /></span></section><section><span><p><img 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发表于 2020-10-14 12:03:51