Varian wins FDA breakthrough nod for microspheres that treat knee osteoarthritis

瓦里安治疗膝骨关节炎微球获得FDA突破性认可

2021-10-14 06:00:10 Mass Device

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Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company, designed Embozene for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene already holds FDA clearance for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia. GAE as a treatment is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process, according to a news release. UCLA Santa Monica and the David Geffen School of Medicine at UCLA Director of Interventional Tadiology Dr. Siddharth Padia said in the release that GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration. According to Padia, a 40-patient study demonstrated a marked improvement in pain and function, with adverse events remaining uncommon and mild. Padia is currently working to initiate a randomized clinical trial and a 400-patient registry.
总部位于加州帕洛阿尔托的西门子健康公司Varian,设计了用于膝动脉栓塞(GAE)治疗症状性膝骨关节炎的Embozene。Embozene已经在栓塞高血管性肿瘤、动静脉畸形、子宫肌瘤和前列腺增生症方面获得FDA批准。 根据一份新闻稿,GAE作为一种治疗方法,旨在减少流向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和加州大学洛杉矶分校大卫·格芬医学院介入治疗学主任Siddharth Padia博士在新闻稿中说,GAE是第一个在很长时间内表现出显著症状改善的微创程序。 根据Padia的说法,一项40例患者的研究表明疼痛和功能有明显改善,不良事件仍然不常见和轻微。Padia目前正致力于启动一项随机临床试验和400名患者的登记。

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