2015年3月15日 讯/生物谷BIOON/ --美敦力是世界最大的医疗器械制造商之一，主要的产品是心脏外科手术使用的器械。美敦力公司宣布其最新的药物洗脱支架进入临床试验阶段，表示将在需要2毫米支架的患者中测试该设备，他们当中的很多病人不符合条件使用这种设备型号。美敦力公司表示这个已获得CE认证的Resolut Onyx设备可以增加手术可见度，并且其更薄的设计能提高支架的传递性。但是最令人兴奋之处是血管更狭小的患者可以使用该设备，这一点将增加该设备的市场潜力。
这项临床试验的主要研究者，来自纽约西奈山医学院的Roxana Mehran在一份声明中说，"作为介入心脏病学家，我们面临的最大挑战是治疗细小的动脉病变，这种情况非常普遍的发生于糖尿病患者。"这项利用CoreWire技术的Resolute Onyx DES支架临床试验的开始在提供治疗难治性冠状动脉病变的选择上迈进了令人兴奋的一步。此外，美敦力公司表示，这种支架利用了它的持续正弦曲线的制造技术，可以通过制作单股线来达到实现一系列连续运动的目的。它将使用去年曾介绍过的NC Euphora气球导管全新传递系统。
去年11月Resolute Onyx获得了CE认证，已经可以在欧洲使用。前一代的Resolute Integrity药物洗脱支架在美国已经可以使用。
该支架与雅培的Xience产品线是竞争对手。雅培公司表示他们的药物洗脱支架可以用于血管直径在2.25到4.25毫米的患者。
生物谷推荐英文原文报道：
Medtronic launches U.S. clinical trial of its newest drug-eluting stent
Medtronic ($MDT) announced the launch of U.S. clinical trials for its latest drug-eluting stent, saying it will test the device on patients in need of a two-millimeter stent, many of whom are not eligible for the device type.
The company says features of the CE-marked Resolute Onyx include increased visibility during surgery and thinner struts that enable improved deliverability. But it is most excited about using the device in patients with a smaller vessel size, which would increase the potential market for the device.
"One of the biggest challenges we face as interventional cardiologists is treating small, diseased coronary arteries--a common condition seen frequently in patients with diabetes," said the study's principal investigator, Roxana Mehran of the Mount Sinai School of Medicine in New York City, in a statement. "The trial initiation of the Resolute Onyx DES with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions." In addition, Medtronic said the device uses its continuous sinusoid technology manufacturing methodology that molds a single strand of wire to achieve a continuous range of motion. It will use a new delivery system that was introduced last year with the NC Euphora balloon catheter.
The Resolute Onyx received a CE mark for use in Europe in November. The prior generation Resolute Integrity drug eluting stent is available in the U.S.
The Resolute drug-eluting stents compete with Abbott's Xience line. Abbott ($ABT) says its drug-eluting stents are indicated for use in patients with vessel diameter between or equal to 2.25 and 4.25 millimeters.