Medtronic today announced it has received approval of a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE), to initiate its pivotal clinical trial of the Prevail™ coronary paclitaxel drug-coated balloon (DCB) for in stent restenosis (ISR) and de novo small vessel disease.

美敦力今天宣布，它已获得美国食品和药物管理局（FDA）研究设备豁免（IDE）的批准，启动其针对支架内再狭窄（ISR）和新生小血管疾病的Prevail™冠状动脉紫杉醇药物涂层球囊（DCB）的关键临床试验。

Data from the Prevail Global Clinical Program will be used to support approval of the Prevail DCB in Japan and the U.S..

Prevail 全球临床项目的数据将用于支持 Prevail DCB 在日本和美国获得批准。

The multi-center, dual cohort clinical trial will enroll up to 1,205 patients with coronary artery disease from approximately 65 global centers across the U.S., Europe and Asia Pacific. The trial will include a randomized controlled evaluation of ISR patients and a single arm evaluation of de novo small vessel disease patients to assess the safety and efficacy of the Prevail DCB.   .

这项多中心、双队列临床试验将招募来自美国、欧洲和亚太地区约65个全球中心的1205名冠心病患者。该试验将包括对ISR患者的随机对照评估和对新生小血管疾病患者的单臂评估，以评估Prevail DCB的安全性和有效性。。

“As physicians treat more patients with complex lesions, it is important to have a device that helps to maintain durable patency while preserving future treatment options,” said David Kandzari, M.D., chief, Piedmont Heart Institute and Cardiovascular Services in Atlanta and co-principal investigator of the Prevail Global Study.

亚特兰大皮埃蒙特心脏研究所和心血管服务中心主任兼Prevail全球研究联合首席研究员DavidKandzari医学博士说：“随着医生治疗越来越多的复杂病变患者，重要的是要有一种设备来帮助维持持久的通畅性，同时保留未来的治疗选择。”。

“Drug-coated balloons provide clinicians with an anti-restenosis solution, without the need of a permanent stent. This groundbreaking trial will include the first head-to-head randomized trial of two drug coated balloons in the U.S. and will provide important additional evidence for this growing therapy.”.

“药物涂层气球为临床医生提供了一种抗再狭窄的解决方案，而不需要永久性支架。这项开创性的试验将包括美国首次对两种药物涂层气球进行头对头随机试验，并将为这种日益增长的疗法提供重要的额外证据。”。

The ISR Cohort will be led by Dr. Kandzari and Prof. Bruno Scheller, M.D., professor for Clinical and Experimental Interventional Cardiology at Saarland University, Germany and will randomize patients 1:1 with the Medtronic Prevail DCB and Boston Scientific AGENT™ DCB* to assess non-inferiority.

ISR队列将由Kandzari博士和德国萨尔大学临床和实验介入心脏病学教授Bruno Scheller教授领导，并将使用美敦力Prevail DCB和Boston Scientific AGENT™DCB*对患者进行1:1的随机分组，以评估非劣效性。

The de novo small vessel (DNSV) Cohort will be led by Azeem Latib, M.D., system director of Interventional Cardiology, Montefiore Health System and director of Structural Heart, Montefiore Medical Center & White Plains Hospital, and Darren Mylotte, M.D., consultant cardiologist, Galway University Hospital and School of Medicine, University of Galway, and will compare Prevail DCB against drug eluting stents, the standard of care for small vessel treatment, using a historical control from the extensive body of evidence from the Resolute Onyx Clinical Program.

新生小血管（DNSV）队列将由医学博士Azeem Latib和医学博士Darren Mylotte领导，Azeem Latib是Montefiore Health system介入心脏病学系统主任，也是Montefiore Medical Center&White Plains Hospital结构性心脏主任，Darren Mylotte是高威大学医院和高威大学医学院的心脏病顾问，他们将使用Resolute Onyx临床计划的大量证据进行历史控制，将Prevail DCB与药物洗脱支架（小血管治疗的标准）进行比较。

The primary endpoint for both cohorts will be target lesion failure (TLF) at 12 months. Patients will be followed out to five years..

两个队列的主要终点将是12个月时的靶病变失败（TLF）。患者将被随访五年。。

The Prevail DCB is intended to be used during percutaneous coronary intervention (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旨在用于经皮冠状动脉介入治疗（PCI）过程中，以治疗冠状动脉疾病患者的冠状动脉狭窄或阻塞。在基于导管的手术过程中，球囊在动脉内充气，而药物（紫杉醇）被输送到动脉组织，在那里它被吸收并保留，以提供持久的抗再狭窄作用。。

“The launch of the Prevail IDE study underscores our commitment to pioneering advanced solutions for complex PCI,” stated Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “The Prevail DCB has the potential to be a significant advancement in the coronary market.

“Prevail IDE研究的推出突显了我们致力于开创复杂PCI的先进解决方案，”美敦力心血管投资组合的高级副总裁兼冠状动脉和肾脏去神经支配业务总裁Jason Weidman表示。“Prevail DCB有可能在冠状动脉市场取得重大进展。

Medtronic is proud to invest in the expansion of clinical evidence to bring Prevail to patients globally. As a leader in drug and device combination therapies for vascular diseases, we look forward to collaborating closely with study investigators and the FDA to initiate patient enrollment in the forthcoming months.”.

美敦力自豪地投资于临床证据的扩展，为全球患者带来胜利。。

The Prevail Global Study will build upon the extensive experience from the use of Prevail DCB globally. Prevail DCB was launched in Europe in 2021 with indications for the treatment of de novo lesions, in-stent restenosis, and small vessel disease in the coronary arteries. Its 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全球研究将以全球使用Prevail DCB的丰富经验为基础。Prevail DCB于2021年在欧洲推出，用于治疗新生病变，支架内再狭窄和冠状动脉小血管疾病。其差异化的FreePac™涂层在冠状动脉和外周动脉疾病方面都有广泛的证据，超过10项试验和1600名患者进行了研究。。

The Prevail™ DCB is commercially available in more than 79 countries globally. Within the Prevail Global Study, Prevail DCB is investigational. Prevail DCB is not approved or sold in the U.S. or Japan.

Prevail™DCB在全球79多个国家上市。在Prevail全球研究中，Prevail DCB正在进行调查。Prevail DCB未在美国或日本获得批准或销售。

About Medtronic

关于美敦力

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。总部位于爱尔兰戈尔韦的美敦力公司是全球领先的医疗保健技术公司，通过寻找和寻找解决方案，大胆应对人类面临的最具挑战性的健康问题。。

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。凭借我们丰富的知识、永不满足的好奇心以及帮助所有需要帮助的人的愿望，我们提供了创新技术，每秒钟、每小时、每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 (NYSE:MDT), visit www.Medtronic.com and follow us on LinkedIn. .

随着我们增强洞察力驱动的护理、以人为本的体验以及为我们的世界带来更好的结果，对我们的期望会更高。在我们所做的每件事中，我们都在创造非凡。有关美敦力（纽约证券交易所代码：MDT）的更多信息，请访问www.Medtronic.com并在LinkedIn上关注我们。。