Medtronic, a global leader in healthcare technology, today announced results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) on the Prevail

全球医疗技术领导者美敦力公司今天宣布了来自瑞典冠状动脉造影和血管成形术注册中心 (SCAAR) 关于Prevail 的研究结果。

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paclitaxel-coated balloon catheter (also known as a coronary drug-coated balloon, or DCB). The results were presented as a late-breaking clinical trial at Cardiovascular Research Technologies (CRT) 2025 in Washington, D.C. by Dr. Sacharias von Koch, Department of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Sweden. The real-world data show the Prevail DCB having comparable outcomes with other contemporary DCBs used in the study, suggesting the Prevail DCB as effective treatment for a variety of complex coronary lesions..

紫杉醇涂层球囊导管（也称为冠状动脉药物涂层球囊，或 DCB）。研究结果由瑞典隆德大学斯科讷大学医院心脏病学与临床科学系的萨查里亚斯·冯·科赫博士在华盛顿特区举行的2025年心血管研究技术（CRT）会议上作为最新突破性临床试验发布。真实世界数据表明，Prevail DCB 的效果与其他当代研究中使用的 DCB 相当，这表明 Prevail DCB 可有效治疗各种复杂的冠状动脉病变。

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SCAAR is a nationwide registry including data on all patients in Sweden undergoing coronary angiography. The real-world analysis is the largest study to date comparing different types of DCBs, and it is the largest dataset evaluating the Prevail DCB, with 1,797 patients. The SCAAR data compared the Prevail DCB to other DCBs in a complex patient population, including 61% patients with acute coronary syndrome, 31.8% with diabetes, 55.3% with complex lesions, 22.8% with bifurcation lesions, and 28% in-stent restenosis (ISR).

SCAAR是一个全国性的注册数据库，包含瑞典所有接受冠状动脉造影患者的资料。这项真实世界分析是迄今为止对比不同类型药物涂层球囊（DCB）的最大规模研究，同时也是评估Prevail DCB的最大数据集，涵盖1797名患者。SCAAR的数据在复杂患者群体中将Prevail DCB与其他DCB进行了对比，其中包括61%的急性冠脉综合征患者、31.8%的糖尿病患者、55.3%的复杂病变患者、22.8%的分叉病变患者以及28%的支架内再狭窄（ISR）患者。

Outcomes included all-cause mortality, myocardial infarction (MI), new revascularization with percutaneous coronary intervention (PCI), target lesion definite thrombosis, and target lesion revascularization. Prevail DCB demonstrated low mortality event rates at one year (4.7%) and two years (7.2%) post-procedure.

结果包括全因死亡率、心肌梗死（MI）、经皮冠状动脉介入治疗（PCI）的新血管重建、目标病灶明确血栓形成以及目标病灶血管重建。Prevail DCB 在术后一年（4.7%）和两年（7.2%）表现出较低的死亡事件发生率。

Additionally, the outcomes showed a 98.7% local success rate with the Prevail DCB and very low rates of target lesion thrombosis (0.8% at two years compared to 1.3% with other DCBs). In hybrid PCIs (defined as DCB and stent in the same vessel), Prevail showed lower new MI rates versus other contemporary DCBs..

此外，结果显示，使用Prevail DCB的局部成功率达到98.7%，目标病灶血栓形成率非常低（两年内为0.8%，而其他DCB为1.3%）。在混合PCI（定义为在同一血管中使用DCB和支架）中，与其他当代DCB相比，Prevail显示出较低的新发心肌梗死率。

The Prevail DCB is intended for use during PCI procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. During the catheter-based procedure, the balloon inflates within the artery, while the drug (paclitaxel) is delivered to the arterial tissue where it is absorbed and retained to provide a durable anti-restenotic effect.

Prevail DCB 适用于在经皮冠状动脉介入治疗（PCI）手术中，用于治疗冠状动脉疾病患者的狭窄或阻塞的冠状动脉。在基于导管的手术过程中，球囊在动脉内膨胀，同时药物（紫杉醇）被输送到动脉组织，在那里被吸收并保留，以提供持久的抗再狭窄效果。

The Prevail DCB’s differentiated FreePac™ coating has an extensive body of evidence in both coronary and peripheral artery disease with over 10 trials and 1,600 patients studied..

Prevail DCB的差异化FreePac™涂层在冠状动脉和外周动脉疾病中拥有超过10项试验和1600名患者研究的广泛证据。

“As physicians encounter and treat an increasing number of patients with complex lesions, it is crucial to continuously gather data on our Prevail DCB,” stated Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Medtronic Cardiovascular Portfolio.

“随着医生遇到并治疗越来越多的复杂病变患者，持续收集我们Prevail药物涂层球囊（DCB）的数据变得至关重要，”美敦力心血管产品组合中冠状动脉与肾去神经业务的高级副总裁兼总裁Jason Weidman表示。

“With its differentiated design, Prevail has seen strong market adoptions since 2021, and we are eager to see how this new data will further advance the Prevail DCB in the market. These findings reaffirm Medtronic’s dedication to advancing complex PCI solutions, ultimately bringing this procedure to patients worldwide.”.

“凭借其差异化的设计，自2021年以来，Prevail已经获得了强劲的市场认可，我们渴望看到这些新数据将如何进一步推动Prevail DCB在市场上的发展。这些发现再次证实了美敦力致力于推进复杂的PCI解决方案，最终将这一手术带给全球患者。”

The Prevail™ DCB is commercially available in more than 80 countries globally. Prevail received approval from the U.S. FDA in October 2024 for an investigational device exemption (IDE) to begin the Prevail Global study, which

Prevail™ DCB 已在全球 80 多个国家上市。Prevail 于 2024 年 10 月获得美国 FDA 的研究设备豁免 (IDE) 批准，以启动 Prevail Global 研究，该研究...

recently enrolled

最近注册

its first patient.

它的第一位患者。

The Prevail DCB is not approved or sold in the U.S. or Japan, and the use of the DCB in the Prevail Global study is investigational.

Prevail DCB 尚未在美国或日本获得批准或销售，Prevail Global 研究中使用 DCB 属于研究性质。

* Always refer to the approved product labeling for the indications, safety, and warning information.

* 始终参考经批准的产品标签以获取适应症、安全性和警告信息。

About Medtronic

美敦力公司简介

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更大胆的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，勇敢地应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、无尽的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

随着我们推动以洞察力为导向的护理、以人为本的体验以及为我们的世界带来更好的结果，期待我们做得更多。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力的更多信息，请访问。

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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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