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SOUTH JORDAN, Utah, May 14, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege Vascular Plug. Merit also announced the launch of its Bearing nsPVA Express Prefilled Syringe in the United States and Australia..
犹他州南约旦,2024年5月14日(环球通讯社)--医疗保健技术的全球领导者Merit Medical Systems,Inc.(纳斯达克:MMSI)今天宣布美国食品和药物管理局(FDA)510(k)批准其围攻血管塞。Merit还宣布在美国和澳大利亚推出其轴承nsPVA Express预充注射器。。
The latest additions to Merit’s Embolics portfolio, Siege Vascular Plug and Bearing nsPVA Express, complement a comprehensive offering of microsphere, particle, and gelatin foam products supported by a range of microcatheters, guide wires, and other enabling devices.
Merit栓塞产品组合的最新产品Sized Vascular Plug和Bearing nsPVA Express补充了由一系列微导管、导丝和其他支持设备支持的微球、颗粒和明胶泡沫产品的全面供应。
Embolization is a minimally invasive procedure where physicians implant devices or materials to occlude blood vessels or abnormal vascular channels. It may be used to stop bleeding or to block the flow of blood to a tumor or abnormal area of tissue. Embolization has made remarkable advances in recent years, becoming a widely adopted treatment option..
栓塞是一种微创手术,医生植入装置或材料以阻塞血管或异常血管通道。它可用于止血或阻断血液流向肿瘤或组织异常区域。近年来,栓塞取得了显着进展,成为广泛采用的治疗选择。。
The Siege Vascular Plug has a highly deliverable, recapturable design that enables precise placement. The nitinol self-expanding plug achieves vessel occlusion within 1.3 minutes.1 Available in three sizes, Siege treats peripheral arteries 1.5 mm to 6.0 mm in diameter. All sizes of the Siege Vascular Plug are delivered with a microcatheter..
攻城血管塞具有高度可交付、可重现的设计,可以精确放置。镍钛合金自膨胀塞可在1.3分钟内实现血管闭塞。1有三种尺寸,Sizege可治疗直径为1.5毫米至6.0毫米的外周动脉。所有尺寸的围城血管塞都配有微导管。。
“The Siege Vascular Plug will be a valuable addition to my clinical practice. A plug with rapid occlusion, precise placement, and microcatheter compatibility is important to me,” said Gary Siskin, MD, Professor and Chairman of the Radiology Department at Albany Medical Center in Albany, NY, and paid consultant of Merit..
纽约州奥尔巴尼市奥尔巴尼医学中心放射学系主任、教授加里·西斯金(Gary Siskin)医学博士(Gary Siskin)表示:“围城血管塞将对我的临床实践产生宝贵的帮助。具有快速闭塞、精确放置和微导管兼容性的血管塞对我很重要。”。。
The newly launched Bearing nsPVA Express is a 20-mL, vacuum-sealed syringe prefilled with Merit-manufactured Bearing nsPVA® Embolization Particles. Bearing nsPVA Embolization Particles are small, irregularly shaped, biocompatible, hydrophilic, and nonresorbable particles available in multiple sizes (45-1180 µm).
新推出的Bearing nsPVA Express是一款20毫升真空密封注射器,预装有Merit制造的带有nsPVA®栓塞颗粒的注射器。携带nsPVA栓塞颗粒是小的,不规则形状的,生物相容的,亲水的和不可吸收的颗粒,可用于多种尺寸(45-1180μm)。
The preloaded syringe offers convenience and ease of use that can save clinicians’ time and minimize product waste. In hands-on testing, 100% of clinicians found the Bearing nsPVA Express to be easily incorporated into a procedure, and 75% said it was easier to use than the vial product.1.
预加载注射器提供了方便和易用性,可以节省临床医生的时间并最大程度地减少产品浪费。在实际操作测试中,100%的临床医生发现携带nsPVA Express很容易纳入程序,75%的临床医生说它比小瓶产品更容易使用。
“Bearing nsPVA Express streamlines embolization procedures. It eliminates a number of steps involved in using PVA in a vial,” said Jafar Golzarian, MD, Interventional Radiologist and Founder at Northstar Vascular and Interventional in Golden Valley, MN. “Unlike vial products, it’s ready to use, enabling interventional radiologists to focus on the procedure.”.
“携带nsPVA Express可以简化栓塞程序。它消除了在小瓶中使用PVA所涉及的许多步骤,”介入放射科医生兼明尼苏达州金谷Northstar Vascular and Interventive创始人Jafar Golzarian说。“与小瓶产品不同,它可以随时使用,使介入放射科医生能够专注于该程序。”。
As part of its commitment to innovation, education, and research in embolotherapy, Merit will participate in the 18th Annual Global Embolization Oncology Symposium Technologies (GEST) Meeting, to be held May 16-19, 2024, in New York City, NY. In addition to introducing the Siege Vascular Plug and Bearing nsPVA Express, Merit will be exhibiting other embolic product solutions, including Embosphere® Microspheres, EmboCube™ Embolization Gelatin, and Torpedo™ Gelatin Foam.
作为其对栓塞治疗创新,教育和研究的承诺的一部分,Merit将参加2024年5月16日至19日在纽约市举行的第18届全球栓塞肿瘤学研讨会技术(GEST)年会。除了推出Size血管塞和轴承nsPVA Express外,Merit还将展出其他栓塞产品解决方案,包括Embosphere®微球、EmboCube™栓塞明胶和鱼雷™明胶泡沫。
Merit will also feature the SwiftNINJA® Steerable Microcatheter and the longer-length Merit Maestro® Microcatheter; both delivery systems are ideal for radial procedures..
Merit还将配备SwiftNINJA®可操纵微导管和更长长度的Merit Maestro®微导管;两种输送系统都是放射状手术的理想选择。。
Physicians can try these products through hands-on workshops held at the Merit booth. GEST attendees will also have access to Merit’s simulator for added prostatic artery embolization and uterine fibroid embolization experience involving Embosphere Microspheres and other Merit devices.
医生可以通过在美德展台举办的实践研讨会来尝试这些产品。GEST与会者还可以访问Merit的模拟器,以增加前列腺动脉栓塞和子宫肌瘤栓塞的经验,包括栓塞微球和其他Merit设备。
“Merit is a leader in embolotherapy,” said Fred P. Lampropoulos, Merit Chairman and Chief Executive Officer. “Through continued investment in new product solutions, we have developed a strong record of delivering meaningful innovation, new indications, and portfolio extensions designed to meet the needs of our healthcare partners.
“Merit是栓塞疗法的领导者,”Merit董事长兼首席执行官弗雷德·兰普洛斯(FredP.Lampropoulos)表示。“通过对新产品解决方案的持续投资,我们在提供有意义的创新、新适应症和投资组合扩展方面取得了良好的记录,旨在满足我们医疗保健合作伙伴的需求。
We look forward to demonstrating this excellence at GEST, showcasing the ways we help physicians deliver a better patient experience.”.
我们期待着在GEST展示这种卓越,展示我们帮助医生提供更好患者体验的方式。”。
ABOUT MERIT MEDICAL
关于MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling over 700 individuals.
Merit Medical Systems,Inc.成立于1987年,致力于开发、制造和分销用于介入、诊断和治疗程序的专有一次性医疗设备,特别是在心脏病学、放射学、肿瘤学、重症监护和内窥镜检查中。Merit为全球客户医院提供服务,拥有国内外销售团队和临床支持团队,共计700多人。