<p>（第一财经）3 月 2 日——在中国主动脉和外周血管介入医疗器械制造商微创心通宣布其创新支架移植物系统获得美国食品药品监督管理局的突破性医疗器械认证后，微创心通的股票大幅上涨。</p>
<p>微创心通 [SHA: 688016] 今日收盘上涨 10.2%，报每股 111.80 元人民币（16.30 美元）。更广泛的上海股市上涨 0.5%。自去年年底以来，该股已上涨 22%。</p>
<p>微创心通在昨日晚间的股票交易所公告中表示，赫克托多支支气管主动脉支架移植物系统将获得优先审查和多项好处，包括在获得突破性医疗器械认证后加速审查流程。</p>
<p>该设备旨在对涉及主动脉弓所有三个分支的胸主动脉病变进行微创介入治疗，微创心通指出，此外它可以将血管内主动脉治疗扩展到整个主动脉弓，为患者提供更全面的手术选择，满足迫切的临床需求。</p>
<p>欧盟去年 7 月授予赫克托支架移植物系统定制医疗器械认证。该设备自此已在欧洲推出用于临床使用和推广，但尚未获得中国或美国监管机构的市场批准。</p>
<p>微创心通在 2 月 28 日的年度财报中表示，该支架移植物系统已进入中国的市场前多中心临床试验阶段，并已被纳入中国监管审查下的创新医疗器械绿色通道。</p>
<p>根据报告，微创心通去年的净利润同比增长 12%，达到 5.63 亿元人民币（7830 万美元），收入也同比增长 12%，达到 14 亿元人民币（1.878 亿美元），这得益于多款创新产品在中国的推出。海外销售猛增超过 55%，达到 2.5 亿元人民币。</p>
<p>主动脉弓病变具有极高的临床风险，若发生动脉瘤破裂，死亡率超过 80%。传统的开胸手术侵入性强，恢复时间长，且神经损伤风险高，而现有的支架系统则涉及非常高的手术和并发症风险。</p>
<p>然而，微创心通的新支架移植物系统能够实现微创的血管内治疗，同时实现主动脉及三大弓分支的血管内重建。根据该公司的官方网站，该系统在欧洲的多例临床案例中取得了良好的效果。</p>
<p>编辑：马丁·卡迪耶夫</p>

微电生理

招商中证全指医疗器械ETF

微创心通-B-新

心脉医疗

微创医疗

医疗器械ETF

微创机器人-B

微创脑科学

华夏中证全指医疗器械ETF

<p>微创心通的股票上涨了 10.2%，达到每股 111.80 元人民币，此次上涨是因为美国 FDA 授予其创新支架移植物系统突破性医疗器械认证，从而加快了市场批准进程。Hector 多支支架胸主动脉支架系统旨在对胸主动脉病变进行微创治疗。微创心通报告称，去年净利润增长 12%，达到 5.63 亿元人民币，这得益于创新产品的推出和海外销售增长 55%。该设备已获得欧盟认证，并在中国进行临床试验，旨在以更少的侵入性方法解决高风险的主动脉弓病变问题</p>

<p>(Yicai) March 2 -- Shares of MicroPort Endovascular MedTech Group surged after the Chinese aortic and peripheral vascular interventional medical devices maker said the US Food and Drug Administration granted Breakthrough Device Designation to its innovative stent graft system, which will likely speed up its market approval.</p>
<div class="lb-trans"><p>（第一财经）3 月 2 日——在中国主动脉和外周血管介入医疗器械制造商微创心通宣布其创新支架移植物系统获得美国食品药品监督管理局的突破性医疗器械认证后，微创心通的股票大幅上涨。</p>
</div><p>MicroPort [SHA: 688016] closed 10.2 percent higher at CNY111.80 (USD16.30) a share today. The broader Shanghai stock market climbed 0.5 percent. The stock has soared 22 percent since the end of last year.</p>
<div class="lb-trans"><p>微创心通 [SHA: 688016] 今日收盘上涨 10.2%，报每股 111.80 元人民币（16.30 美元）。更广泛的上海股市上涨 0.5%。自去年年底以来，该股已上涨 22%。</p>
</div><p>The Hector Multi-Branch Thoracic Aortic Stent Graft System will receive priority review and multiple benefits, including an accelerated review process following the Breakthrough Device Designation, Shanghai-based MicroPort said in a stock exchange filing late yesterday.</p>
<div class="lb-trans"><p>微创心通在昨日晚间的股票交易所公告中表示，赫克托多支支气管主动脉支架移植物系统将获得优先审查和多项好处，包括在获得突破性医疗器械认证后加速审查流程。</p>
</div><p>The device is intended for minimally invasive interventional treatment of thoracic aortic lesions involving all three branches of the aortic arch, MicroPort noted, adding that it can extend endovascular aortic treatment to the entire aortic arch, offering patients more comprehensive surgical options and addressing an urgent clinical need.</p>
<div class="lb-trans"><p>该设备旨在对涉及主动脉弓所有三个分支的胸主动脉病变进行微创介入治疗，微创心通指出，此外它可以将血管内主动脉治疗扩展到整个主动脉弓，为患者提供更全面的手术选择，满足迫切的临床需求。</p>
</div><p>The European Union granted the Hector stent graft system a custom device certification last July. The device has since been launched for clinical use and promotion in Europe, but has not yet received marketing approval from regulators in China or the United States.</p>
<div class="lb-trans"><p>欧盟去年 7 月授予赫克托支架移植物系统定制医疗器械认证。该设备自此已在欧洲推出用于临床使用和推广，但尚未获得中国或美国监管机构的市场批准。</p>
</div><p>The stent graft system has entered the pre-market multi-center clinical trial phase in China and has been accepted into the green channel for innovative medical devices under Chinese regulatory review, MicroPort said in an annual earnings report on Feb. 28.</p>
<div class="lb-trans"><p>微创心通在 2 月 28 日的年度财报中表示，该支架移植物系统已进入中国的市场前多中心临床试验阶段，并已被纳入中国监管审查下的创新医疗器械绿色通道。</p>
</div><p>MicroPort's net profit rose 12 percent to CNY563 million (USD78.3 million) last year from the previous year, with its revenue also jumping 12 percent to CNY1.4 billion (USD187.8 million) thanks to the launch of multiple innovative products in China, according to the report. Overseas sales soared more than 55 percent to CNY250 million.</p>
<div class="lb-trans"><p>根据报告，微创心通去年的净利润同比增长 12%，达到 5.63 亿元人民币（7830 万美元），收入也同比增长 12%，达到 14 亿元人民币（1.878 亿美元），这得益于多款创新产品在中国的推出。海外销售猛增超过 55%，达到 2.5 亿元人民币。</p>
</div><p>Aortic arch lesions carry extremely high clinical risks, with a mortality rate of over 80 percent in the event of aneurysm rupture. Traditional open-chest surgeries are highly invasive, require long recovery times, and carry a high risk of nerve injury, while existing stent systems involve very high surgical and complication risks.</p>
<div class="lb-trans"><p>主动脉弓病变具有极高的临床风险，若发生动脉瘤破裂，死亡率超过 80%。传统的开胸手术侵入性强，恢复时间长，且神经损伤风险高，而现有的支架系统则涉及非常高的手术和并发症风险。</p>
</div><p>However, MicroPort's new stent graft system enables minimally invasive endovascular treatment while achieving endovascular reconstruction of the aorta and the three major arch branches. It has achieved favorable outcomes in multiple clinical cases performed in Europe, according to the website of the company.</p>
<div class="lb-trans"><p>然而，微创心通的新支架移植物系统能够实现微创的血管内治疗，同时实现主动脉及三大弓分支的血管内重建。根据该公司的官方网站，该系统在欧洲的多例临床案例中取得了良好的效果。</p>
</div><p>Editor: Martin Kadiev</p>
<div class="lb-trans"><p>编辑：马丁·卡迪耶夫</p>
</div>

China's MicroPort Soars After US Grants Its New Stent Breakthrough Device Status

Yicai

中国的微创医疗在美国授予其新型支架突破性设备状态后股价大幅上涨