Varian Receives FDA Breakthrough Device Designation For Embozene® Microspheres For Genicular Artery Embolization For Symptomatic Knee Osteoarthritis

Varian获得FDA突破性装置命名,用于膝动脉栓塞治疗症状性膝骨关节炎的Embozene®微球

2021-10-14 02:00:09 BioSpace

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Varian, Inc., a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration has granted the company Breakthrough Device Designation for its Embozene® microspheres for genicular artery embolization for symptomatic knee osteoarthritis. Embozene is a medical device that is FDA cleared for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia. Embozene microspheres received this designation due to their potential to offer a more effective treatment for appropriate patients with osteoarthritis of the knee. GAE is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process. "GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration," said Siddharth Padia, M.D, director, Interventional Radiology at UCLA Santa Monica and the David Geffen School of Medicine at UCLA. "In a 40-patient, prospective study, the procedure resulted in a marked improvement in pain and function, and adverse events were uncommon and mild. I remain excited about the possibilities of this technology and its benefit to patients." Dr. Padia is currently working to initiate a randomized clinical trial and a 400-patient registry. Osteoarthritis is the most common form of arthritis and is a "wear and tear" degenerative joint disease that affects the cartilage and surrounding tissues.1 The knee is the joint that is most commonly affected with osteoarthritis and knee osteoarthritis is the leading cause of disability in the U.S. adult population.2,3 It is estimated that 14 million individuals in the United States have symptomatic knee osteoarthritis, with half suffering from advanced knee osteoarthritis.4 The management of osteoarthritis of the knee is estimated to cost the United States healthcare system from $5.7 to $15 billion annually.5 Treatment for osteoarthritis often escalates from over-the-counter medications and physical therapy to cortisone injections and sometimes knee replacement surgery. "GAE holds great promise in providing clinicians with a new, non-invasive treatment option, which may not only ameliorate pain, but reduce the economic burden of this common disease," said Frank Facchini, MD, FSIR, president, Varian Interventional Solutions. "Varian's investigational program for GAE exemplifies our commitment to investing in our core technologies to determine their potential to treat the world's most debilitating diseases."  The FDA Breakthrough Device Program is intended to provide patients with more timely access to medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. As part of the program, the FDA expedites the traditional review and assessment process to help accelerate the development, assessment and review of the device for possible approval. About Varian Interventional Solutions Varian and Siemens Healthineers are investing in the future of interventional radiology. By partnering with interventional radiologists and researchers in the field, we are delivering a portfolio of intelligent solutions to benefit patients around the globe. We're committed to enhancing the patient experience at every stage of care by developing and delivering innovative solutions in ablation, embolization and beyond. About Varian At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 11,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com and follow @VarianMedSys on Twitter. Press Contact Lynne Tran Corporate Communications publicrelations@varian.com Investor Relations Contact Siemens Healthineers Investor Relations 1     United States Bone and Joint Initiative: The Burden of Musculoskeletal Diseases in the United States (BMUS), Fourth Edition. Rosemont, IL. Available at http://www.boneandjointburden.orgexternal icon. Accessed on June 10, 2021. 2     Felson DT, Naimark A, Anderson J, et al. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987;30:914–8. 3     Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: A review of community burden and current use of primary health care. Ann Rheum Dis. 2001;60:91–7. 4     Deshpande BR, Katz JN, Solomon DH, et al. Number of persons with symptomatic knee osteoarthritis in the us: impact of race and ethnicity, age, sex, and obesity. Arthritis Care Res. 2016;68:1743-1750. doi: 10.1002/acr.22897. 5     Bedenbaugh AV, Bonafede M, Marchlewicz EH, et al. Real-World Health Care Resource Utilization and Costs Among US Patients with Knee Osteoarthritis Compared with Controls. Clinicoecon Outcomes Res. 2021;13:421-435. doi: 10.2147/CEOR.S302289. View original content:https://www.prnewswire.com/news-releases/varian-receives-fda-breakthrough-device-designation-for-embozene-microspheres-for-genicular-artery-embolization-for-symptomatic-knee-osteoarthritis-301398761.html SOURCE Varian
西门子Healthineers公司Varian,Inc.今天宣布,美国食品药品监督管理局已批准该公司的Embozene®微球用于膝动脉栓塞治疗症状性膝骨关节炎的突破性设备指定。Embozene是美国FDA批准的用于栓塞高血管性肿瘤、动静脉畸形、子宫肌瘤和良性前列腺增生的医疗设备。 Embozene微球获得这一指定,因为它们有潜力为适当的膝骨关节炎患者提供更有效的治疗。GAE旨在减少关节周围组织的血流量,限制炎症过程。 加州大学洛杉矶分校圣莫尼卡分校介入放射学主任和加州大学洛杉矶分校大卫·格芬医学院的Siddharth Padia医学博士说:“GAE是第一个在很长一段时间内表现出显著症状改善的微创手术。”“在一项40名患者的前瞻性研究中,该手术显著改善了疼痛和功能,不良事件罕见且轻微。我仍然对这项技术的可能性及其对患者的益处感到兴奋。”帕迪亚博士目前正致力于启动一项随机临床试验和400名患者的登记。 骨关节炎是最常见的关节炎形式,是一种影响软骨和周围组织的“磨损”退行性关节疾病。1膝关节是最常见的骨关节炎的关节,膝关节骨关节炎是美国成年人致残的主要原因。2,3据估计,美国有1400万人患有症状性膝关节骨关节炎,4据估计,治疗膝骨关节炎每年花费美国医疗保健系统57亿至150亿美元。5骨关节炎的治疗经常从非处方药和物理治疗升级到注射可的松,有时还进行膝关节置换手术。 “GAE在为临床医生提供一种新的、无创的治疗选择方面有很大的希望,不仅可以减轻疼痛,还可以减轻这种常见疾病的经济负担,”Frank Facchini博士说,他是FSIR的主席,瓦里安介入解决方案公司的总裁。“瓦里安对GAE的研究项目体现了我们对核心技术投资的承诺,以确定它们治疗世界上最虚弱疾病的潜力。” FDA突破性设备计划旨在为患者提供更及时的医疗设备,这些设备有可能为威胁生命或不可逆转的虚弱疾病或条件提供更有效的治疗或诊断。作为该项目的一部分,FDA加快了传统的审查和评估过程,以帮助加快该设备的开发、评估和审查,以获得可能的批准。 关于卵巢介入治疗的探讨 瓦里安和西门子Healthineers正在投资介入放射学的未来。通过与介入放射学家和该领域的研究人员合作,我们正在提供一系列智能解决方案,以造福全球患者。我们致力于通过开发和提供消融、栓塞等方面的创新解决方案来提高患者在每个护理阶段的体验。 关于瓦里安 在西门子医疗保健公司Varian,我们设想一个没有癌症恐惧的世界。70多年来,我们为全球各地的临床合作伙伴开发、构建和提供了创新的癌症护理技术和解决方案,帮助他们每年治疗数百万患者。通过智能癌症护理方法,我们正在利用人工智能、机器学习和数据分析等先进技术来加强癌症治疗和扩大获得护理的机会。我们在70个地点的11000名员工将病人和我们的临床合作伙伴放在我们思考的中心,因为我们在癌症护理方面取得了新的胜利。因为,对于各地的癌症患者来说,他们的战斗就是我们的战斗。欲了解更多信息,请访问http://www.varian.com,并在推特上关注@varianmedsys。 新闻联络 林恩·陈 企业传播 publicrelations@varian.com 投资者关系联络 西门子Healthineers投资者关系 1美国骨与关节倡议:美国肌肉骨骼疾病的负担(BMUS),第四版。伊利诺伊州罗斯蒙特。可在http://www.boneandjointburden.orgexternal icon查阅。2021年6月10日访问。 2 Felson DT,Naimark A,Anderson J,et al.老年人膝骨性关节炎的患病率。弗雷明汉骨关节炎研究。大黄关节炎。1987年;30:914-8。 3 Peat G,McCarney R,Croft P.老年人的膝痛和骨关节炎:社区负担和目前初级卫生保健使用的回顾。安·莱厄姆·迪斯。2001年;60:91-7。 4 Deshpande BR,Katz JN,Solomon DH,et al.美国有症状性膝骨关节炎的人数:种族和民族、年龄、性别和肥胖的影响。关节炎护理报告,2016;68:1743-1750。DOI:10.1002/ACR.22897。 5 Bedenbaugh AV,Bonafede M,Marchlewicz EH,et al.美国膝骨关节炎患者与对照组的真实世界卫生保健资源利用和成本比较。临床研究结果,2021;13:421-435。DOI:10.2147/CEOR.S302289。 查看原始内容:https://www.prnewswire.com/news-releases/varian-receives-fda-breakthrough-device-designation-for-embozene-micropheres-for-genicular-arteraction-mempolation-for-thermatic-knee-osteoarthritis-301398761.html 来源瓦里安

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