Medtronic, a global leader in healthcare technology, today announced that the first patient has been enrolled in the PEripheral Onyx™ Liquid Embolic (PELE) clinical trial, which will evaluate the safety and effectiveness of the Onyx™ Liquid Embolic System (LES) for embolization of arterial hemorrhage in the peripheral vasculature. The first procedure was performed by Dr. Christopher Stark at Albany Medical Center.

医疗保健技术的全球领导者美敦力 （Medtronic） 今天宣布，PE沿岸 Onyx™ Liquid E栓塞 （PELE） 临床试验已招募首例患者，该试验将评估 Onyx™ 液体栓塞系统 （LES） 栓塞外周血管动脉出血的安全性和有效性。第一个程序由奥尔巴尼医疗中心的 Christopher Stark 博士进行。

Data from the PELE IDE Clinical Study is intended to evaluate the safety and effectiveness of Onyx LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature that are deemed suitable for embolization treatment.  In this study, peripheral vasculature is defined as outside of the brain and heart..

PELE IDE临床研究的数据旨在评估Onyx LES在治疗被认为适合栓塞治疗的外周血管活动性动脉出血患者中的安全性和有效性。在本研究中，外周血管定义为脑和心脏之外的区域。

“Embolic agents are an important tool to address hemorrhage. In this case, the patient experienced bleeding due to a ruptured blood vessel following a routine medical procedure. Onyx LES was administered into the target vessel to successfully facilitate embolization,” said Chistopher Stark, M.D., vascular and interventional radiologist at Albany Medical Center.

“栓塞剂是解决出血的重要工具。在此案例中，患者因常规医疗程序后血管破裂而出现出血。Onyx LES被注入目标血管，成功实现了栓塞，”奥尔巴尼医学中心的血管和介入放射科医生克里斯托弗·斯塔克医学博士说道。

“Albany Medical Center is proud to be enrolling patients in the PELE IDE Clinical Study, the aim of which is to gather evidence to support the safety and efficacy of Onyx LES in treatment of peripheral arterial hemorrhage.”.

“奥尔巴尼医疗中心自豪地在PELE IDE临床研究中招募患者，该研究的目的是收集证据以支持Onyx LES在治疗外周动脉出血方面的安全性和有效性。”

This pivotal, prospective, multi-center, non-randomized, single arm study will enroll up to 119 patients from up to 25 sites in the U.S.  The primary safety and efficacy endpoints will be evaluated through 30 days following treatment with Onyx LES.

这项关键的、前瞻性的、多中心、非随机、单臂研究将在美国多达25个地点招募最多119名患者。主要安全性和有效性终点将在使用Onyx LES治疗后30天内进行评估。

“Onyx LES is available with a peripheral indication in many markets outside the U.S.,” said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “This trial will generate the evidence necessary for U.S. physicians to use Onyx for embolization of arterial hemorrhage in the peripheral vasculature, a key part of advancing our embolic portfolio strategy.”.

“在许多美国以外的市场，Onyx LES已获得用于外周适应症的许可，”美敦力心血管产品组合中周围血管健康业务总裁大卫·莫勒表示。“这项试验将为美国医生使用Onyx进行外周血管动脉出血栓塞提供必要的证据，这也是推进我们的栓塞产品组合战略的关键部分。”

The PELE IDE Clinical Study will build upon extensive commercial experience from the use of Onyx LES in the peripheral vasculature globally. It aims to provide the necessary evidence to add Onyx LES to the U.S. portfolio of peripheral vasculature embolization products from Medtronic. In the United States, the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature is investigational and has not been approved or cleared by the U.S.

PELE IDE临床研究将基于全球范围内使用Onyx LES在周围血管中的广泛商业经验。该研究旨在提供必要的证据，以将Onyx LES添加到美敦力在美国的周围血管栓塞产品组合中。在美国，使用Onyx LES进行周围血管动脉出血栓塞仍属于研究性质，尚未获得美国相关机构的批准或认可。

Food and Drug Administration.   .

食品药品监督管理局。

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，通过寻找和发现解决方案，勇敢地应对人类面临的最严峻的健康问题。我们的使命——减轻痛苦、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。凭借我们广泛的知识、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。在我们所做的一切中，我们正在创造非凡。欲了解有关美敦力的更多信息，请访问。